SlideShare ist ein Scribd-Unternehmen logo
1 von 5
Generic Drugs
A generic drug is a pharmaceutical drug that has the same chemical substance as
the drug that was originally developed, patented and innovated. Generic drugs are
allowed for sale after the expiry of the patent of the original drugs. Because the
active chemical substance is the same, the medical profile of generics is believed to
be equivalent in performance. The generic drug has the same active pharmaceutical
ingredient (API) as the original, but it may differ in characteristics such as
manufacturing process,formulation, excipient, color, taste, and packaging.
Although they may not be associated with a particular company, generic drugs are
usually subject to government regulations in the countries in which they are
dispensed. They are labeled with the name of the manufacturer and a generic
nonproprietary name such as the United States Adopted Name or international
nonproprietary name of the drug. A generic drug must contain the same active
ingredients as the original brand name formulation. The U.S. Food and Drug
Administration (FDA) requires generics to be identical to or within an
acceptable bioequivalent range of their brand name counterparts, with respect
to pharmacokinetic and pharmacodynamics properties. (The FDA's use of the word
"identical" is a legal interpretation, not literal.)
Biopharmaceuticals, such as monoclonal antibodies, differ biologically from small
molecule drugs. Bio similars have active pharmaceutical ingredients that are
almost identical to the original product and are typically regulated under an
extended set of rules, but they are not the same since generic drugs as the active
ingredients are not the same as those of their reference products.
In most cases, generic products become available after the patent protections,
afforded to a drug's original developer, expire. Once generic drugs enter the
market, competition often leads to substantially lower prices for both the original
brand name product and its generic equivalents. In most countries, patents give 20
years of protection. However, many countries and regions, such as the European
Union and the United States, may grant up to five years of additional protection
("patent term restoration") if manufacturers meet specific goals, such as
conducting clinical trials for pediatric patients.
Manufacturers, wholesalers, insurers, and drug stores can all increase prices at
various stages of production and distribution. In 2014, according to an analysis by
the Generic Pharmaceutical Association, generic drugs accounted for 88% of the
4.3 billion prescriptions filled in the United States.
"Branded generics" on the other hand are defined by the FDA and NHS as
"products that are (a) either novel dosage forms of off-patent products produced by
a manufacturer that is not the originator of the molecule, or (b) a molecule copy of
an off-patent product with a trade name. Since the company making branded
generics can spend little on research and development, it is able to spend on
marketing alone, thus earning higher profits and driving costs down. For example,
the largest revenues of Ranbaxy, now owned by Sun Pharma, came from branded
generics.
What is a drug patent definition?
Medical Definition of patent medicine: a packaged nonprescription drug which is
protected by a trademark and whose contents are incompletely disclosed; also: any
drug that is a proprietary.
Patent medicines are NOT medicines that have been patented. They are instead
proprietary (i.e., "secret formula") and unproved remedies advertised and sold
directly to the public. The growth of the patent medicine industry was rooted in the
medical shortcomings of the early 19th century.
How long does a drug patent last in the US?
Now, patents protect drugs from copycat versions for 20 years after the drug is
invented. This is a bitter pill for pharmaceutical companies because it can
take eight years or more after invention to accumulate enough data to get a drug
past the U.S. Food and Drug Administration.
Are generic drugs safe?
Yes. The FDA requires that all drugs be safe and effective. Since generics use the
same active ingredients and are shown to work the same way in the body, they
have the same risks and benefits as their brand-name counterparts.
Brand Name
Branded medicines are medicines which have a name given to them by a company
for the purpose of advertising. Branded medicines may be the original
medicine developed by a company or several companies may make the same
generic medicine, to which each company gives its own brand name.
Why generic medicines are cheaper?
Generic makers don't face the same costs as manufacturers of brand-name drugs.
That's because the brand-name maker often invented the drug, a process that can
cost hundreds of millions of dollars. ... That is an enormous economic advantage
for these companies, which is why their drugs can be much cheaper.
What is a branded generic?
Generic drugs are frequently as effective as, but much cheaper than, brand-name
drugs.2 Many generic medicines are marketed using only the generic name and are
not given a brand name. A branded generic is the brand name given to a drug that
is bioequivalent to the original (innovator).
Is generic medicine less effective?
A generic medicine is the same as a brand-name medicine in dosage, safety,
effectiveness, strength, stability, and quality, as well as in the way it is taken and
should be used. The FDA Generic Drugs Program conducts a rigorous review to
make sure generic medicines meet these requirements.
Can pharmacist substitute generic drugs?
A pharmacist may substitute a therapeutically equivalent drug product listed in the
current state drug formulary. ... A pharmacist may substitute with a generic product
unless the FDA has determined that a drug product of the same generic name is not
bioequivalent to the prescribed brand name prescription medication.
Generic Drugs- Why is it important?
A generic drug is equivalent to the brand name drug. After a brand name drug is
developed after considerable amount of research and after the patent expires,
generic drugs can be manufactured and sold to customers at very cheap rates.
According to the US FDA, “A generic drug is identical or bioequivalent to a brand
name drug in dosage, form, safety, strength, root of administration and intended
use.”
As we shall see, very often the cost difference is so much that even well to do
people cannot afford a branded drug while the generic version can be afforded.
Take the case of Novartis. It sells its anti cancer drug for treating chronic myeloid
leukemia ‘Gleevec’ for Rs. 1.2 lakh per month. The generic version costs Rs.
8000/month. The drug is out of patent in India and thus the generic drug can be
sold.
Novartis is fighting a case for grant of patent on a new, crystalline salt form of the
anti cancer drug ‘Immatinib Mesylate’ which it sold under the brand name
Gleevec. A patent on this new form could provide another 20 year monopoly to
Novartis. Such practices are called evergreening of patent.
Reference:
1. https://www.google.com
2. http://greencleanguide.com/generic-drugs/

Weitere ähnliche Inhalte

Was ist angesagt?

Brand drug vs generic drug
Brand drug vs generic drugBrand drug vs generic drug
Brand drug vs generic drugShubham Paul
 
Pharmaceutical marketing by vikram mathariya
Pharmaceutical marketing by vikram mathariyaPharmaceutical marketing by vikram mathariya
Pharmaceutical marketing by vikram mathariyaAshish Agrawal
 
Abbreviated New Drug Application [ANDA]
Abbreviated New Drug Application [ANDA]Abbreviated New Drug Application [ANDA]
Abbreviated New Drug Application [ANDA]Sagar Savale
 
common mobile apps in medical practice
common mobile apps in medical practicecommon mobile apps in medical practice
common mobile apps in medical practicedr tushar chokshi
 
Common Technical Document (CTD)
Common Technical Document (CTD)Common Technical Document (CTD)
Common Technical Document (CTD)Swapnil Fernandes
 
Over the Counter Drugs (OTC DRUGS)
Over the Counter Drugs (OTC DRUGS)Over the Counter Drugs (OTC DRUGS)
Over the Counter Drugs (OTC DRUGS)Umair hanif
 
Regulations of medical devices in india
Regulations of medical devices in indiaRegulations of medical devices in india
Regulations of medical devices in indiasuspandanachowdary
 
Over the counter (OTC) sales
Over the counter (OTC) salesOver the counter (OTC) sales
Over the counter (OTC) salessunayanamali
 
BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory)2. unit ii, chapter-1 reg...
BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory)2. unit ii, chapter-1 reg...BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory)2. unit ii, chapter-1 reg...
BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory)2. unit ii, chapter-1 reg...Audumbar Mali
 
New Drug Application [NDA]
New Drug Application [NDA]New Drug Application [NDA]
New Drug Application [NDA]Sagar Savale
 
Online Pharmacy Views & Counter Views
Online Pharmacy Views & Counter ViewsOnline Pharmacy Views & Counter Views
Online Pharmacy Views & Counter ViewsTausif Momin
 
5. Unit-V- Regulatory Concepts.
5. Unit-V- Regulatory Concepts.5. Unit-V- Regulatory Concepts.
5. Unit-V- Regulatory Concepts.Audumbar Mali
 
Regulatory Affairs.
Regulatory Affairs.Regulatory Affairs.
Regulatory Affairs.Naila Kanwal
 
Generic drug product development
Generic drug product developmentGeneric drug product development
Generic drug product developmentBashant Kumar sah
 

Was ist angesagt? (20)

Brand drug vs generic drug
Brand drug vs generic drugBrand drug vs generic drug
Brand drug vs generic drug
 
Pharmaceutical marketing by vikram mathariya
Pharmaceutical marketing by vikram mathariyaPharmaceutical marketing by vikram mathariya
Pharmaceutical marketing by vikram mathariya
 
Abbreviated New Drug Application [ANDA]
Abbreviated New Drug Application [ANDA]Abbreviated New Drug Application [ANDA]
Abbreviated New Drug Application [ANDA]
 
common mobile apps in medical practice
common mobile apps in medical practicecommon mobile apps in medical practice
common mobile apps in medical practice
 
Common Technical Document (CTD)
Common Technical Document (CTD)Common Technical Document (CTD)
Common Technical Document (CTD)
 
ind
indind
ind
 
Anda
AndaAnda
Anda
 
Over the Counter Drugs (OTC DRUGS)
Over the Counter Drugs (OTC DRUGS)Over the Counter Drugs (OTC DRUGS)
Over the Counter Drugs (OTC DRUGS)
 
final year project
final year projectfinal year project
final year project
 
Regulations of medical devices in india
Regulations of medical devices in indiaRegulations of medical devices in india
Regulations of medical devices in india
 
Over the counter (OTC) sales
Over the counter (OTC) salesOver the counter (OTC) sales
Over the counter (OTC) sales
 
BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory)2. unit ii, chapter-1 reg...
BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory)2. unit ii, chapter-1 reg...BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory)2. unit ii, chapter-1 reg...
BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory)2. unit ii, chapter-1 reg...
 
Cdsco ppt
Cdsco pptCdsco ppt
Cdsco ppt
 
New Drug Application [NDA]
New Drug Application [NDA]New Drug Application [NDA]
New Drug Application [NDA]
 
Pharmacovigilance
PharmacovigilancePharmacovigilance
Pharmacovigilance
 
Online Pharmacy Views & Counter Views
Online Pharmacy Views & Counter ViewsOnline Pharmacy Views & Counter Views
Online Pharmacy Views & Counter Views
 
Achyutha anda
Achyutha andaAchyutha anda
Achyutha anda
 
5. Unit-V- Regulatory Concepts.
5. Unit-V- Regulatory Concepts.5. Unit-V- Regulatory Concepts.
5. Unit-V- Regulatory Concepts.
 
Regulatory Affairs.
Regulatory Affairs.Regulatory Affairs.
Regulatory Affairs.
 
Generic drug product development
Generic drug product developmentGeneric drug product development
Generic drug product development
 

Ähnlich wie Why Generic Drugs Are Important for Affordable Healthcare

pharma regulatory a
pharma regulatory apharma regulatory a
pharma regulatory aswapy123
 
What you want to know about generic drugs
What you want to know about generic drugsWhat you want to know about generic drugs
What you want to know about generic drugsstewart granger
 
Generic Medication vs Brand name
Generic Medication vs Brand nameGeneric Medication vs Brand name
Generic Medication vs Brand namegarreth mulany
 
Myths about generic medicines
Myths about generic medicinesMyths about generic medicines
Myths about generic medicinesSastasundar
 
Kwality Generics and Medicose.pptx
Kwality Generics and Medicose.pptxKwality Generics and Medicose.pptx
Kwality Generics and Medicose.pptxKwalityGenerics
 
Kwality Generics and Medicose.pdf
Kwality Generics and Medicose.pdfKwality Generics and Medicose.pdf
Kwality Generics and Medicose.pdfKwalityGenerics
 
Indian pharma and generic medicines
Indian pharma and generic medicinesIndian pharma and generic medicines
Indian pharma and generic medicinespuneet552001
 
Facts about Generics Drugs
Facts about Generics DrugsFacts about Generics Drugs
Facts about Generics DrugsPhilip Jopar
 
20180808 generic drug approval yuan愿 song宋
20180808 generic drug approval yuan愿 song宋20180808 generic drug approval yuan愿 song宋
20180808 generic drug approval yuan愿 song宋Yuan愿 Song宋
 
Generic drug and WTO
Generic drug and WTOGeneric drug and WTO
Generic drug and WTOVishu1234567
 
An Introduction to Generic Pharmaceuticals
An Introduction to Generic PharmaceuticalsAn Introduction to Generic Pharmaceuticals
An Introduction to Generic PharmaceuticalsDV Medical Supply
 
ANDA FDA APPLICATION
ANDA FDA APPLICATIONANDA FDA APPLICATION
ANDA FDA APPLICATIONRoshan Bodhe
 
Drug Bulletin of Nepal
Drug Bulletin of Nepal Drug Bulletin of Nepal
Drug Bulletin of Nepal Nabin Bist
 

Ähnlich wie Why Generic Drugs Are Important for Affordable Healthcare (20)

What are Generic medicines ????
What are Generic medicines ????What are Generic medicines ????
What are Generic medicines ????
 
pharma regulatory a
pharma regulatory apharma regulatory a
pharma regulatory a
 
Swapnil2
Swapnil2Swapnil2
Swapnil2
 
Patents and Generic.pptx
Patents and Generic.pptxPatents and Generic.pptx
Patents and Generic.pptx
 
Patents and Generic.pptx
Patents and Generic.pptxPatents and Generic.pptx
Patents and Generic.pptx
 
What you want to know about generic drugs
What you want to know about generic drugsWhat you want to know about generic drugs
What you want to know about generic drugs
 
Generic name
Generic nameGeneric name
Generic name
 
Generic Medication vs Brand name
Generic Medication vs Brand nameGeneric Medication vs Brand name
Generic Medication vs Brand name
 
SCHEDULE W.pptx
SCHEDULE W.pptxSCHEDULE W.pptx
SCHEDULE W.pptx
 
Myths about generic medicines
Myths about generic medicinesMyths about generic medicines
Myths about generic medicines
 
Kwality Generics and Medicose.pptx
Kwality Generics and Medicose.pptxKwality Generics and Medicose.pptx
Kwality Generics and Medicose.pptx
 
Kwality Generics and Medicose.pdf
Kwality Generics and Medicose.pdfKwality Generics and Medicose.pdf
Kwality Generics and Medicose.pdf
 
Indian pharma and generic medicines
Indian pharma and generic medicinesIndian pharma and generic medicines
Indian pharma and generic medicines
 
Facts about Generics Drugs
Facts about Generics DrugsFacts about Generics Drugs
Facts about Generics Drugs
 
Anda 2011 ppt raaj gprac
Anda 2011 ppt raaj gpracAnda 2011 ppt raaj gprac
Anda 2011 ppt raaj gprac
 
20180808 generic drug approval yuan愿 song宋
20180808 generic drug approval yuan愿 song宋20180808 generic drug approval yuan愿 song宋
20180808 generic drug approval yuan愿 song宋
 
Generic drug and WTO
Generic drug and WTOGeneric drug and WTO
Generic drug and WTO
 
An Introduction to Generic Pharmaceuticals
An Introduction to Generic PharmaceuticalsAn Introduction to Generic Pharmaceuticals
An Introduction to Generic Pharmaceuticals
 
ANDA FDA APPLICATION
ANDA FDA APPLICATIONANDA FDA APPLICATION
ANDA FDA APPLICATION
 
Drug Bulletin of Nepal
Drug Bulletin of Nepal Drug Bulletin of Nepal
Drug Bulletin of Nepal
 

Mehr von Bishnu Koirala

Stability basic concepts and purposes
Stability basic concepts and purposesStability basic concepts and purposes
Stability basic concepts and purposesBishnu Koirala
 
Environmental aspects and impacts
Environmental aspects and impactsEnvironmental aspects and impacts
Environmental aspects and impactsBishnu Koirala
 
Candidiasis, causes and their treatment
Candidiasis, causes and their treatmentCandidiasis, causes and their treatment
Candidiasis, causes and their treatmentBishnu Koirala
 
Preformulation and product development
Preformulation and product developmentPreformulation and product development
Preformulation and product developmentBishnu Koirala
 
High grade prostatic intraepithelial neoplasia
High grade prostatic intraepithelial neoplasiaHigh grade prostatic intraepithelial neoplasia
High grade prostatic intraepithelial neoplasiaBishnu Koirala
 
general knowledge about Viral infection (fever).
general knowledge about Viral infection (fever). general knowledge about Viral infection (fever).
general knowledge about Viral infection (fever). Bishnu Koirala
 
Shelf life calculation of drugs
Shelf life calculation of drugsShelf life calculation of drugs
Shelf life calculation of drugsBishnu Koirala
 
Basic concept of process validation
Basic concept of process validation Basic concept of process validation
Basic concept of process validation Bishnu Koirala
 
International legal consideration
International legal considerationInternational legal consideration
International legal considerationBishnu Koirala
 
Pharmacovigilance by bishnu koirala
Pharmacovigilance by bishnu koiralaPharmacovigilance by bishnu koirala
Pharmacovigilance by bishnu koiralaBishnu Koirala
 
Herbal medicine & cosmetics by bishnu koirala
Herbal medicine & cosmetics by bishnu koiralaHerbal medicine & cosmetics by bishnu koirala
Herbal medicine & cosmetics by bishnu koiralaBishnu Koirala
 
Regulatory affairs by bishnu koirala
Regulatory affairs by bishnu koiralaRegulatory affairs by bishnu koirala
Regulatory affairs by bishnu koiralaBishnu Koirala
 
container closure system
container closure systemcontainer closure system
container closure systemBishnu Koirala
 

Mehr von Bishnu Koirala (14)

Stability basic concepts and purposes
Stability basic concepts and purposesStability basic concepts and purposes
Stability basic concepts and purposes
 
Environmental aspects and impacts
Environmental aspects and impactsEnvironmental aspects and impacts
Environmental aspects and impacts
 
Candidiasis, causes and their treatment
Candidiasis, causes and their treatmentCandidiasis, causes and their treatment
Candidiasis, causes and their treatment
 
Preformulation and product development
Preformulation and product developmentPreformulation and product development
Preformulation and product development
 
High grade prostatic intraepithelial neoplasia
High grade prostatic intraepithelial neoplasiaHigh grade prostatic intraepithelial neoplasia
High grade prostatic intraepithelial neoplasia
 
general knowledge about Viral infection (fever).
general knowledge about Viral infection (fever). general knowledge about Viral infection (fever).
general knowledge about Viral infection (fever).
 
Shelf life calculation of drugs
Shelf life calculation of drugsShelf life calculation of drugs
Shelf life calculation of drugs
 
Basic concept of process validation
Basic concept of process validation Basic concept of process validation
Basic concept of process validation
 
Isotonic solution
Isotonic solutionIsotonic solution
Isotonic solution
 
International legal consideration
International legal considerationInternational legal consideration
International legal consideration
 
Pharmacovigilance by bishnu koirala
Pharmacovigilance by bishnu koiralaPharmacovigilance by bishnu koirala
Pharmacovigilance by bishnu koirala
 
Herbal medicine & cosmetics by bishnu koirala
Herbal medicine & cosmetics by bishnu koiralaHerbal medicine & cosmetics by bishnu koirala
Herbal medicine & cosmetics by bishnu koirala
 
Regulatory affairs by bishnu koirala
Regulatory affairs by bishnu koiralaRegulatory affairs by bishnu koirala
Regulatory affairs by bishnu koirala
 
container closure system
container closure systemcontainer closure system
container closure system
 

Kürzlich hochgeladen

Lucknow Call girls - 8800925952 - 24x7 service with hotel room
Lucknow Call girls - 8800925952 - 24x7 service with hotel roomLucknow Call girls - 8800925952 - 24x7 service with hotel room
Lucknow Call girls - 8800925952 - 24x7 service with hotel roomdiscovermytutordmt
 
Manyata Tech Park ( Call Girls ) Bangalore ✔ 6297143586 ✔ Hot Model With Sexy...
Manyata Tech Park ( Call Girls ) Bangalore ✔ 6297143586 ✔ Hot Model With Sexy...Manyata Tech Park ( Call Girls ) Bangalore ✔ 6297143586 ✔ Hot Model With Sexy...
Manyata Tech Park ( Call Girls ) Bangalore ✔ 6297143586 ✔ Hot Model With Sexy...vidya singh
 
Call Girls Nagpur Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Nagpur Just Call 9907093804 Top Class Call Girl Service AvailableCall Girls Nagpur Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Nagpur Just Call 9907093804 Top Class Call Girl Service AvailableDipal Arora
 
Best Rate (Patna ) Call Girls Patna ⟟ 8617370543 ⟟ High Class Call Girl In 5 ...
Best Rate (Patna ) Call Girls Patna ⟟ 8617370543 ⟟ High Class Call Girl In 5 ...Best Rate (Patna ) Call Girls Patna ⟟ 8617370543 ⟟ High Class Call Girl In 5 ...
Best Rate (Patna ) Call Girls Patna ⟟ 8617370543 ⟟ High Class Call Girl In 5 ...Dipal Arora
 
Call Girls Ooty Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Ooty Just Call 9907093804 Top Class Call Girl Service AvailableCall Girls Ooty Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Ooty Just Call 9907093804 Top Class Call Girl Service AvailableDipal Arora
 
Top Rated Bangalore Call Girls Mg Road ⟟ 9332606886 ⟟ Call Me For Genuine S...
Top Rated Bangalore Call Girls Mg Road ⟟   9332606886 ⟟ Call Me For Genuine S...Top Rated Bangalore Call Girls Mg Road ⟟   9332606886 ⟟ Call Me For Genuine S...
Top Rated Bangalore Call Girls Mg Road ⟟ 9332606886 ⟟ Call Me For Genuine S...narwatsonia7
 
Call Girls Gwalior Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Gwalior Just Call 9907093804 Top Class Call Girl Service AvailableCall Girls Gwalior Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Gwalior Just Call 9907093804 Top Class Call Girl Service AvailableDipal Arora
 
Call Girls Bareilly Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Bareilly Just Call 9907093804 Top Class Call Girl Service AvailableCall Girls Bareilly Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Bareilly Just Call 9907093804 Top Class Call Girl Service AvailableDipal Arora
 
Call Girls Haridwar Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Haridwar Just Call 9907093804 Top Class Call Girl Service AvailableCall Girls Haridwar Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Haridwar Just Call 9907093804 Top Class Call Girl Service AvailableDipal Arora
 
Pondicherry Call Girls Book Now 9630942363 Top Class Pondicherry Escort Servi...
Pondicherry Call Girls Book Now 9630942363 Top Class Pondicherry Escort Servi...Pondicherry Call Girls Book Now 9630942363 Top Class Pondicherry Escort Servi...
Pondicherry Call Girls Book Now 9630942363 Top Class Pondicherry Escort Servi...Genuine Call Girls
 
(Low Rate RASHMI ) Rate Of Call Girls Jaipur ❣ 8445551418 ❣ Elite Models & Ce...
(Low Rate RASHMI ) Rate Of Call Girls Jaipur ❣ 8445551418 ❣ Elite Models & Ce...(Low Rate RASHMI ) Rate Of Call Girls Jaipur ❣ 8445551418 ❣ Elite Models & Ce...
(Low Rate RASHMI ) Rate Of Call Girls Jaipur ❣ 8445551418 ❣ Elite Models & Ce...parulsinha
 
Russian Escorts Girls Nehru Place ZINATHI 🔝9711199012 ☪ 24/7 Call Girls Delhi
Russian Escorts Girls  Nehru Place ZINATHI 🔝9711199012 ☪ 24/7 Call Girls DelhiRussian Escorts Girls  Nehru Place ZINATHI 🔝9711199012 ☪ 24/7 Call Girls Delhi
Russian Escorts Girls Nehru Place ZINATHI 🔝9711199012 ☪ 24/7 Call Girls DelhiAlinaDevecerski
 
Premium Bangalore Call Girls Jigani Dail 6378878445 Escort Service For Hot Ma...
Premium Bangalore Call Girls Jigani Dail 6378878445 Escort Service For Hot Ma...Premium Bangalore Call Girls Jigani Dail 6378878445 Escort Service For Hot Ma...
Premium Bangalore Call Girls Jigani Dail 6378878445 Escort Service For Hot Ma...tanya dube
 
Book Paid Powai Call Girls Mumbai 𖠋 9930245274 𖠋Low Budget Full Independent H...
Book Paid Powai Call Girls Mumbai 𖠋 9930245274 𖠋Low Budget Full Independent H...Book Paid Powai Call Girls Mumbai 𖠋 9930245274 𖠋Low Budget Full Independent H...
Book Paid Powai Call Girls Mumbai 𖠋 9930245274 𖠋Low Budget Full Independent H...Call Girls in Nagpur High Profile
 
Call Girls Gwalior Just Call 8617370543 Top Class Call Girl Service Available
Call Girls Gwalior Just Call 8617370543 Top Class Call Girl Service AvailableCall Girls Gwalior Just Call 8617370543 Top Class Call Girl Service Available
Call Girls Gwalior Just Call 8617370543 Top Class Call Girl Service AvailableDipal Arora
 
VIP Service Call Girls Sindhi Colony 📳 7877925207 For 18+ VIP Call Girl At Th...
VIP Service Call Girls Sindhi Colony 📳 7877925207 For 18+ VIP Call Girl At Th...VIP Service Call Girls Sindhi Colony 📳 7877925207 For 18+ VIP Call Girl At Th...
VIP Service Call Girls Sindhi Colony 📳 7877925207 For 18+ VIP Call Girl At Th...jageshsingh5554
 
Call Girls Bangalore Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Bangalore Just Call 9907093804 Top Class Call Girl Service AvailableCall Girls Bangalore Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Bangalore Just Call 9907093804 Top Class Call Girl Service AvailableDipal Arora
 
Top Rated Bangalore Call Girls Ramamurthy Nagar ⟟ 9332606886 ⟟ Call Me For G...
Top Rated Bangalore Call Girls Ramamurthy Nagar ⟟  9332606886 ⟟ Call Me For G...Top Rated Bangalore Call Girls Ramamurthy Nagar ⟟  9332606886 ⟟ Call Me For G...
Top Rated Bangalore Call Girls Ramamurthy Nagar ⟟ 9332606886 ⟟ Call Me For G...narwatsonia7
 
Best Rate (Hyderabad) Call Girls Jahanuma ⟟ 8250192130 ⟟ High Class Call Girl...
Best Rate (Hyderabad) Call Girls Jahanuma ⟟ 8250192130 ⟟ High Class Call Girl...Best Rate (Hyderabad) Call Girls Jahanuma ⟟ 8250192130 ⟟ High Class Call Girl...
Best Rate (Hyderabad) Call Girls Jahanuma ⟟ 8250192130 ⟟ High Class Call Girl...astropune
 
Call Girls Varanasi Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Varanasi Just Call 9907093804 Top Class Call Girl Service AvailableCall Girls Varanasi Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Varanasi Just Call 9907093804 Top Class Call Girl Service AvailableDipal Arora
 

Kürzlich hochgeladen (20)

Lucknow Call girls - 8800925952 - 24x7 service with hotel room
Lucknow Call girls - 8800925952 - 24x7 service with hotel roomLucknow Call girls - 8800925952 - 24x7 service with hotel room
Lucknow Call girls - 8800925952 - 24x7 service with hotel room
 
Manyata Tech Park ( Call Girls ) Bangalore ✔ 6297143586 ✔ Hot Model With Sexy...
Manyata Tech Park ( Call Girls ) Bangalore ✔ 6297143586 ✔ Hot Model With Sexy...Manyata Tech Park ( Call Girls ) Bangalore ✔ 6297143586 ✔ Hot Model With Sexy...
Manyata Tech Park ( Call Girls ) Bangalore ✔ 6297143586 ✔ Hot Model With Sexy...
 
Call Girls Nagpur Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Nagpur Just Call 9907093804 Top Class Call Girl Service AvailableCall Girls Nagpur Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Nagpur Just Call 9907093804 Top Class Call Girl Service Available
 
Best Rate (Patna ) Call Girls Patna ⟟ 8617370543 ⟟ High Class Call Girl In 5 ...
Best Rate (Patna ) Call Girls Patna ⟟ 8617370543 ⟟ High Class Call Girl In 5 ...Best Rate (Patna ) Call Girls Patna ⟟ 8617370543 ⟟ High Class Call Girl In 5 ...
Best Rate (Patna ) Call Girls Patna ⟟ 8617370543 ⟟ High Class Call Girl In 5 ...
 
Call Girls Ooty Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Ooty Just Call 9907093804 Top Class Call Girl Service AvailableCall Girls Ooty Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Ooty Just Call 9907093804 Top Class Call Girl Service Available
 
Top Rated Bangalore Call Girls Mg Road ⟟ 9332606886 ⟟ Call Me For Genuine S...
Top Rated Bangalore Call Girls Mg Road ⟟   9332606886 ⟟ Call Me For Genuine S...Top Rated Bangalore Call Girls Mg Road ⟟   9332606886 ⟟ Call Me For Genuine S...
Top Rated Bangalore Call Girls Mg Road ⟟ 9332606886 ⟟ Call Me For Genuine S...
 
Call Girls Gwalior Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Gwalior Just Call 9907093804 Top Class Call Girl Service AvailableCall Girls Gwalior Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Gwalior Just Call 9907093804 Top Class Call Girl Service Available
 
Call Girls Bareilly Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Bareilly Just Call 9907093804 Top Class Call Girl Service AvailableCall Girls Bareilly Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Bareilly Just Call 9907093804 Top Class Call Girl Service Available
 
Call Girls Haridwar Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Haridwar Just Call 9907093804 Top Class Call Girl Service AvailableCall Girls Haridwar Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Haridwar Just Call 9907093804 Top Class Call Girl Service Available
 
Pondicherry Call Girls Book Now 9630942363 Top Class Pondicherry Escort Servi...
Pondicherry Call Girls Book Now 9630942363 Top Class Pondicherry Escort Servi...Pondicherry Call Girls Book Now 9630942363 Top Class Pondicherry Escort Servi...
Pondicherry Call Girls Book Now 9630942363 Top Class Pondicherry Escort Servi...
 
(Low Rate RASHMI ) Rate Of Call Girls Jaipur ❣ 8445551418 ❣ Elite Models & Ce...
(Low Rate RASHMI ) Rate Of Call Girls Jaipur ❣ 8445551418 ❣ Elite Models & Ce...(Low Rate RASHMI ) Rate Of Call Girls Jaipur ❣ 8445551418 ❣ Elite Models & Ce...
(Low Rate RASHMI ) Rate Of Call Girls Jaipur ❣ 8445551418 ❣ Elite Models & Ce...
 
Russian Escorts Girls Nehru Place ZINATHI 🔝9711199012 ☪ 24/7 Call Girls Delhi
Russian Escorts Girls  Nehru Place ZINATHI 🔝9711199012 ☪ 24/7 Call Girls DelhiRussian Escorts Girls  Nehru Place ZINATHI 🔝9711199012 ☪ 24/7 Call Girls Delhi
Russian Escorts Girls Nehru Place ZINATHI 🔝9711199012 ☪ 24/7 Call Girls Delhi
 
Premium Bangalore Call Girls Jigani Dail 6378878445 Escort Service For Hot Ma...
Premium Bangalore Call Girls Jigani Dail 6378878445 Escort Service For Hot Ma...Premium Bangalore Call Girls Jigani Dail 6378878445 Escort Service For Hot Ma...
Premium Bangalore Call Girls Jigani Dail 6378878445 Escort Service For Hot Ma...
 
Book Paid Powai Call Girls Mumbai 𖠋 9930245274 𖠋Low Budget Full Independent H...
Book Paid Powai Call Girls Mumbai 𖠋 9930245274 𖠋Low Budget Full Independent H...Book Paid Powai Call Girls Mumbai 𖠋 9930245274 𖠋Low Budget Full Independent H...
Book Paid Powai Call Girls Mumbai 𖠋 9930245274 𖠋Low Budget Full Independent H...
 
Call Girls Gwalior Just Call 8617370543 Top Class Call Girl Service Available
Call Girls Gwalior Just Call 8617370543 Top Class Call Girl Service AvailableCall Girls Gwalior Just Call 8617370543 Top Class Call Girl Service Available
Call Girls Gwalior Just Call 8617370543 Top Class Call Girl Service Available
 
VIP Service Call Girls Sindhi Colony 📳 7877925207 For 18+ VIP Call Girl At Th...
VIP Service Call Girls Sindhi Colony 📳 7877925207 For 18+ VIP Call Girl At Th...VIP Service Call Girls Sindhi Colony 📳 7877925207 For 18+ VIP Call Girl At Th...
VIP Service Call Girls Sindhi Colony 📳 7877925207 For 18+ VIP Call Girl At Th...
 
Call Girls Bangalore Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Bangalore Just Call 9907093804 Top Class Call Girl Service AvailableCall Girls Bangalore Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Bangalore Just Call 9907093804 Top Class Call Girl Service Available
 
Top Rated Bangalore Call Girls Ramamurthy Nagar ⟟ 9332606886 ⟟ Call Me For G...
Top Rated Bangalore Call Girls Ramamurthy Nagar ⟟  9332606886 ⟟ Call Me For G...Top Rated Bangalore Call Girls Ramamurthy Nagar ⟟  9332606886 ⟟ Call Me For G...
Top Rated Bangalore Call Girls Ramamurthy Nagar ⟟ 9332606886 ⟟ Call Me For G...
 
Best Rate (Hyderabad) Call Girls Jahanuma ⟟ 8250192130 ⟟ High Class Call Girl...
Best Rate (Hyderabad) Call Girls Jahanuma ⟟ 8250192130 ⟟ High Class Call Girl...Best Rate (Hyderabad) Call Girls Jahanuma ⟟ 8250192130 ⟟ High Class Call Girl...
Best Rate (Hyderabad) Call Girls Jahanuma ⟟ 8250192130 ⟟ High Class Call Girl...
 
Call Girls Varanasi Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Varanasi Just Call 9907093804 Top Class Call Girl Service AvailableCall Girls Varanasi Just Call 9907093804 Top Class Call Girl Service Available
Call Girls Varanasi Just Call 9907093804 Top Class Call Girl Service Available
 

Why Generic Drugs Are Important for Affordable Healthcare

  • 1. Generic Drugs A generic drug is a pharmaceutical drug that has the same chemical substance as the drug that was originally developed, patented and innovated. Generic drugs are allowed for sale after the expiry of the patent of the original drugs. Because the active chemical substance is the same, the medical profile of generics is believed to be equivalent in performance. The generic drug has the same active pharmaceutical ingredient (API) as the original, but it may differ in characteristics such as manufacturing process,formulation, excipient, color, taste, and packaging. Although they may not be associated with a particular company, generic drugs are usually subject to government regulations in the countries in which they are dispensed. They are labeled with the name of the manufacturer and a generic nonproprietary name such as the United States Adopted Name or international nonproprietary name of the drug. A generic drug must contain the same active ingredients as the original brand name formulation. The U.S. Food and Drug Administration (FDA) requires generics to be identical to or within an acceptable bioequivalent range of their brand name counterparts, with respect to pharmacokinetic and pharmacodynamics properties. (The FDA's use of the word "identical" is a legal interpretation, not literal.) Biopharmaceuticals, such as monoclonal antibodies, differ biologically from small molecule drugs. Bio similars have active pharmaceutical ingredients that are almost identical to the original product and are typically regulated under an extended set of rules, but they are not the same since generic drugs as the active ingredients are not the same as those of their reference products. In most cases, generic products become available after the patent protections, afforded to a drug's original developer, expire. Once generic drugs enter the market, competition often leads to substantially lower prices for both the original brand name product and its generic equivalents. In most countries, patents give 20 years of protection. However, many countries and regions, such as the European Union and the United States, may grant up to five years of additional protection ("patent term restoration") if manufacturers meet specific goals, such as conducting clinical trials for pediatric patients. Manufacturers, wholesalers, insurers, and drug stores can all increase prices at various stages of production and distribution. In 2014, according to an analysis by
  • 2. the Generic Pharmaceutical Association, generic drugs accounted for 88% of the 4.3 billion prescriptions filled in the United States. "Branded generics" on the other hand are defined by the FDA and NHS as "products that are (a) either novel dosage forms of off-patent products produced by a manufacturer that is not the originator of the molecule, or (b) a molecule copy of an off-patent product with a trade name. Since the company making branded generics can spend little on research and development, it is able to spend on marketing alone, thus earning higher profits and driving costs down. For example, the largest revenues of Ranbaxy, now owned by Sun Pharma, came from branded generics. What is a drug patent definition? Medical Definition of patent medicine: a packaged nonprescription drug which is protected by a trademark and whose contents are incompletely disclosed; also: any drug that is a proprietary. Patent medicines are NOT medicines that have been patented. They are instead proprietary (i.e., "secret formula") and unproved remedies advertised and sold directly to the public. The growth of the patent medicine industry was rooted in the medical shortcomings of the early 19th century. How long does a drug patent last in the US? Now, patents protect drugs from copycat versions for 20 years after the drug is invented. This is a bitter pill for pharmaceutical companies because it can take eight years or more after invention to accumulate enough data to get a drug past the U.S. Food and Drug Administration.
  • 3. Are generic drugs safe? Yes. The FDA requires that all drugs be safe and effective. Since generics use the same active ingredients and are shown to work the same way in the body, they have the same risks and benefits as their brand-name counterparts. Brand Name Branded medicines are medicines which have a name given to them by a company for the purpose of advertising. Branded medicines may be the original medicine developed by a company or several companies may make the same generic medicine, to which each company gives its own brand name. Why generic medicines are cheaper? Generic makers don't face the same costs as manufacturers of brand-name drugs. That's because the brand-name maker often invented the drug, a process that can cost hundreds of millions of dollars. ... That is an enormous economic advantage for these companies, which is why their drugs can be much cheaper. What is a branded generic? Generic drugs are frequently as effective as, but much cheaper than, brand-name drugs.2 Many generic medicines are marketed using only the generic name and are not given a brand name. A branded generic is the brand name given to a drug that is bioequivalent to the original (innovator). Is generic medicine less effective? A generic medicine is the same as a brand-name medicine in dosage, safety, effectiveness, strength, stability, and quality, as well as in the way it is taken and should be used. The FDA Generic Drugs Program conducts a rigorous review to make sure generic medicines meet these requirements.
  • 4. Can pharmacist substitute generic drugs? A pharmacist may substitute a therapeutically equivalent drug product listed in the current state drug formulary. ... A pharmacist may substitute with a generic product unless the FDA has determined that a drug product of the same generic name is not bioequivalent to the prescribed brand name prescription medication. Generic Drugs- Why is it important? A generic drug is equivalent to the brand name drug. After a brand name drug is developed after considerable amount of research and after the patent expires, generic drugs can be manufactured and sold to customers at very cheap rates. According to the US FDA, “A generic drug is identical or bioequivalent to a brand name drug in dosage, form, safety, strength, root of administration and intended use.” As we shall see, very often the cost difference is so much that even well to do people cannot afford a branded drug while the generic version can be afforded. Take the case of Novartis. It sells its anti cancer drug for treating chronic myeloid leukemia ‘Gleevec’ for Rs. 1.2 lakh per month. The generic version costs Rs. 8000/month. The drug is out of patent in India and thus the generic drug can be sold. Novartis is fighting a case for grant of patent on a new, crystalline salt form of the anti cancer drug ‘Immatinib Mesylate’ which it sold under the brand name Gleevec. A patent on this new form could provide another 20 year monopoly to Novartis. Such practices are called evergreening of patent.