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WHAT IS A DRUG?
“Any product used to diagnose, cure,
mitigate, treat, or prevent a disease.”
Stages of Drug Development and Review
The Drug Discovery, Development, and Review Process
6.5 years 7 years 1.5 years
What is GENERIC DRUG Product?
A Generic Drug product is a drug product that is comparable to
an innovator drug product (also known as the reference listed
drug (RLD) product as identified in the FDA’s list of Approved
Drug Products with Therapeutic Equivalence Evaluations)
in dosage form, strength, route of administration, quality,
performance characteristic, and intended use.
Another definition include that Generic drug product is that
drug product which is free from any patent or copyright
Purity and quality
unable to gain
access to the
The Cycle of Innovation and Competition
opens market to
opens market to
The Hatch-Waxman Act/ Drug Price
Competition/ Patent Term Restoration
"The Hatch-Waxman Act is an act dealing with the
approval of generic drugs and associated conditions
for getting their approval from the Food and Drug
Administration (FDA), market exclusivity, rights of
exclusivity, patent term extension and Orange Book
The act was enacted in the USA in 1984.
It was necessitated by the following
Absence of Generic drug manufacturing:
Sometime in the year 1962 it was observed in the
USA that out of the 150 off patent drugs in the
market, there were no generic drugs! Owing to
cumbersome procedures involved, manufacturers
were simply not interested to take up manufacture
of these, even though these were cheaper.
Cumbersome regulatory procedures: Many
companies did not go in for manufacture of generic
drugs because of the impractical and non-scientific
manner in which the regulatory authorities viewed
the approval process and insisted upon proving the
Patients were denied the option of cheaper
HATCH-WAXMAN ACT (1984) LINKED FDA
APPROVAL AND PATENT PROTECTION
Hatch-Waxman applies only to drugs.
It balanced interests of research companies and
Generic companies are now able to use a patented
drug to establish acts related to FDA approval.
Innovator companies may get “patent term restoration” equal to
delay of approval by FDA, up to 5 years, called “marketing
Innovator companies also get protection of safety and
effectiveness data for 5 years after NDA approval, so-called “data
Brand drug companies may seek restoration of some of the
patent life lost during the period of FDA testing/approval up to 5
years (or no more than 14 years between FDA approval and
Patents and Drug Exclusivity
1. Drug patents are granted by the Patent and Trademark
Office and can be granted at any time during the
development of a drug.
2. Drug exclusivity refers to the exclusive marketing rights
granted to a drug upon its approval by the FDA.
FDA MARKETING APPROVAL FOR
GENERIC DRUGS – ABBREVIATED NEW
DRUG APPLICATION (ANDA)
Hatch-Waxman created an ANDA
After expiration of “data exclusivity,” generic
companies may use safety and effectiveness data of
innovator company for their ANDA.
Generic companies must only prove
“bioequivalence” to the innovator’s drug product—
“bioavailability” of the drug at the site of activity in
the body at same potency.
(Abbreviated New Drug Application)
“ANDA” is the abbreviation for Abbreviated New Drug Application.
It contains data which when submitted to FDA’s CDER, office of
generic drugs, provides for the review and ultimate approval of a
generic drug product.
Once approved an applicant may manufacture and market the
generic drug product provided all issues related to patent
protection and exclusivity associated with RLD have been
Generic drug applications are termed “abbreviated” in that they
are generally not required to include preclinical (animal) and
clinical (human) data to establish safety and effectiveness.
These parameters were established upon the approval of the
innovator drug product, which is the first version of the drug
product approved by the FDA.
Intent is to minimize duplication of available information.
Complete chemistry, manufacturing, and controls information.
Information regarding the bioavailability of solid dosage forms.
U.S. Department of
and Human Services
Food and Drug
Center for Biologics
Center for Devices
Center for Drug
Center for Food Safety
and Applied Nutrition
Center for Veterinary
National Center for
Generic Drug Review Process
to Office of
and decides if
Determine if application is acceptable
Generic manufacturers do not need to
complete the three phases of clinical trials
A “Paragraph IV certification” by a generic company states the
applicant believes the patent is invalid (or is unenforceable) or
will not be infringed by the generic product.
Company must send notice to the NDA holder
Notice must include a detailed statement of factual and legal
NDA holder can file a patent infringement suit within 45 days of
receipt of notice.
If suit is filed in 45 days, ANDA approval is delayed for 30
months (during litigation).
Avoiding Patent Infringement
Under Hatch-Waxman Act, Generic Companies Filing
ANDAs are required to certify with the FDA that their
“COPYCAT” DRUGS will not infringe each and every
existing patent on the innovative drug they seek to
copy, which are listed in a printed compendium known
as “Approved Drug Product with Therapeutic
Equivalence” but most commonly called “THE