| Top Generic Drugs |
Generic and Brand-Name Drugs:
What are Generic Drugs
What are Generic Drugs
Home
Drug Discovery
Generics/Brands
Drug
Information
Health
Information
Top Generic
Drugs
Buy Generic
Drugs
About
Links
Drug Discovery
Generics/Brands
Drug
Information
Health
Information
Top Generic
Drugs
Buy Generic
Drugs
About
Links
Brand Drugs and Generic Equivalents. Patent
Protection
Brand name is the name under which a new innovator drug is
developed and marketed. When a pharmaceutical company
develops a new medication, they obtain patent for it. Brand-name
drugs are usually given patent protection for more than 20 years. The
patent protects the company investments (including research,
development, marketing etc.). When the patent expires, other
companies can introduce its generic version. About 50% of the drugs
on the market are now available in generic form.
Efficacy and Safety
Generic drugs are as safe as effective as the brand-name
medications. They show exactly the same pharmacological and
clinical effects, and have the same risks and benefits as their
brand-name counterparts.
Bioequivalence studies
To receive market approval, the pharmaceutical company should
provide evidence that the generic product is bioequivalent, i.e., that it
performs in the same manner as the original. As generic drugs
contain the same active substance, there is no necessity to repeat
the preclinical tests and the clinical trials made with the original.
Instead, they are replaced by bioequivalence studies. These studies,
performed usually on 24-36 healthy human volunteers compare the
time it takes the drug to reach the bloodstream, and the
concentrations of the newly developed medication and the brand
original in the blood. Both drugs are considered bioequivalent when
they show same rate and extent of absorption in the human
organism.
Quality
Both brands and generics are of the same quality, as their facilities
have to meet the same rigorous productions standards of Good
Manufacturing Practice (GMP).
Price
Generic drugs are considerably less expensive than the brand-name
originals, as the generic manufacturers do not carry the investment
costs for the development of a new pharmaceutical. The price of the
generics is 30%- 80% lower than the price of the equivalent brand
product.
Benefits for the Society
Generic medications provide a major benefit to the society, as they
ensure access to quality, safe and effective medicines. Increasing
the range of generic medications is essential for the healthcare. The
healthcare systems save much money by promoting the use of
cost-effective generics. About 50% of all prescriptions in the United
States, and more than 40% of all prescriptions in Canada are filled
with generic drugs.
Protection
Brand name is the name under which a new innovator drug is
developed and marketed. When a pharmaceutical company
develops a new medication, they obtain patent for it. Brand-name
drugs are usually given patent protection for more than 20 years. The
patent protects the company investments (including research,
development, marketing etc.). When the patent expires, other
companies can introduce its generic version. About 50% of the drugs
on the market are now available in generic form.
Efficacy and Safety
Generic drugs are as safe as effective as the brand-name
medications. They show exactly the same pharmacological and
clinical effects, and have the same risks and benefits as their
brand-name counterparts.
Bioequivalence studies
To receive market approval, the pharmaceutical company should
provide evidence that the generic product is bioequivalent, i.e., that it
performs in the same manner as the original. As generic drugs
contain the same active substance, there is no necessity to repeat
the preclinical tests and the clinical trials made with the original.
Instead, they are replaced by bioequivalence studies. These studies,
performed usually on 24-36 healthy human volunteers compare the
time it takes the drug to reach the bloodstream, and the
concentrations of the newly developed medication and the brand
original in the blood. Both drugs are considered bioequivalent when
they show same rate and extent of absorption in the human
organism.
Quality
Both brands and generics are of the same quality, as their facilities
have to meet the same rigorous productions standards of Good
Manufacturing Practice (GMP).
Price
Generic drugs are considerably less expensive than the brand-name
originals, as the generic manufacturers do not carry the investment
costs for the development of a new pharmaceutical. The price of the
generics is 30%- 80% lower than the price of the equivalent brand
product.
Benefits for the Society
Generic medications provide a major benefit to the society, as they
ensure access to quality, safe and effective medicines. Increasing
the range of generic medications is essential for the healthcare. The
healthcare systems save much money by promoting the use of
cost-effective generics. About 50% of all prescriptions in the United
States, and more than 40% of all prescriptions in Canada are filled
with generic drugs.
Facts
Brand-Name Drugs and Generic Equivalents
Of the 11,167 FDA-approved drugs listed in the FDA's Orange Book,
8,400 have generic equivalents.
Sales
The global sales of generic drugs will increase from $29 billion in
2003 to $49 billion in 2007. Generic drug sales will increase an
average of 14% per year (data from IMS Health).
Price
In 2003, the average price of a brand-name drug was $84.21,
whereas the average price of a generic product was $30.56 (data
from the National Association of Chain Drug Stores). Generic drugs
account for 51% of all prescriptions dispensed in the U.S.
Savings
Generic drugs save consumers approximately $8-10 billion each
year at retail pharmacies.
Consumer Attitudes
In a survey performed by ChangeWave Research in 2002, 59% of the
consumers said they ask their doctor if a generic drug is available for
their treatment.
Brand-Name Drugs and Generic Equivalents
Of the 11,167 FDA-approved drugs listed in the FDA's Orange Book,
8,400 have generic equivalents.
Sales
The global sales of generic drugs will increase from $29 billion in
2003 to $49 billion in 2007. Generic drug sales will increase an
average of 14% per year (data from IMS Health).
Price
In 2003, the average price of a brand-name drug was $84.21,
whereas the average price of a generic product was $30.56 (data
from the National Association of Chain Drug Stores). Generic drugs
account for 51% of all prescriptions dispensed in the U.S.
Savings
Generic drugs save consumers approximately $8-10 billion each
year at retail pharmacies.
Consumer Attitudes
In a survey performed by ChangeWave Research in 2002, 59% of the
consumers said they ask their doctor if a generic drug is available for
their treatment.
Top Generic Drugs, Copyright 2004-2008
| Generic Drugs Resources |
FDA Office of Generic Drugs
Profound information on generic
drugs: definition, Q&A, news,
approvals etc.
FDA:
Questions and Answers
Frequently asked questions about
generic drugs
FDA Ensures
Equivalence of Generics
FDA approval of generic drugs,
requirements for brand-name and
generic drugs, myths and facts.
FDA:
Consumer Education
Generic drugs: safe, effective,
FDA approved
EGA:
FAQ on Generics
Frequently asked questions about
generics presented by European
Generic Medicines Association
EGA About Generics:
Glossary
Glossary of terms related to
generic medicines
Profound information on generic
drugs: definition, Q&A, news,
approvals etc.
FDA:
Questions and Answers
Frequently asked questions about
generic drugs
FDA Ensures
Equivalence of Generics
FDA approval of generic drugs,
requirements for brand-name and
generic drugs, myths and facts.
FDA:
Consumer Education
Generic drugs: safe, effective,
FDA approved
EGA:
FAQ on Generics
Frequently asked questions about
generics presented by European
Generic Medicines Association
EGA About Generics:
Glossary
Glossary of terms related to
generic medicines
Generic drugs are considered identical, or bioequivalent to the
brand-name originals. They contain the same active substances as
the original brand-name product and have the same quality, efficacy
and safety. Generic drugs may contain different inactive ingredients
that do not have therapeutic effect.
brand-name originals. They contain the same active substances as
the original brand-name product and have the same quality, efficacy
and safety. Generic drugs may contain different inactive ingredients
that do not have therapeutic effect.