ANDA APPLICATION

1. Roshan Gomaji Bodhe
Pharmaceutics
(M. Pharm. Sem1)
SES,RCPIPER Shirpur Campus

2. WHAT IS A DRUG?
“Any product used to diagnose, cure,
mitigate, treat, or prevent a disease.”

3. Stage 1
Drug
Discovery
Stages of Drug Development and Review
The Drug Discovery, Development, and Review Process
Stage 2
Preclinical
Stage 3
Clinical Trials
Stage 4
FDA Review
6.5 years 7 years 1.5 years
Phase 1
20-100 volunteers
Phase 3
1,000-5,000 volunteers
Phase 2
100-500 volunteers
INDsubmitted
NDAsubmitted
250
compounds
5 compounds
10,000
compounds
1
FDA
approved
drug
Stage 5
Post
Marketing
Trials
Phase 4
several
hundred to
several
thousand
Entire Life
Cycle

4. 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
protection.

5. GENERICS
Active ingredients
Purity and quality
Amount absorbed
Dosage
Manufacturer’s processing
Safety
Efficacy

6. Marketplace
Branded
Generic Generic
Entrance to
Marketplace
Patents and
Exclusivity
Generics are
unable to gain
access to the
marketplace

7. The Cycle of Innovation and Competition
Branded company
innovates
Branded company
rewarded with
monopoly position
Generics are
distributed;
branded company
loses revenue
Patent expiration
opens market to
generic competition
Branded company
innovates
Branded company
rewarded with
monopoly position
Patent expiration
opens market to
generic competition
Generics are
distributed;
branded company
loses revenue

8. The Hatch-Waxman Act/ Drug Price
Competition/ Patent Term Restoration
Act (1984)
 "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
Listing."
 The act was enacted in the USA in 1984.

9.  It was necessitated by the following
observations:
 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
obvious.
 Patients were denied the option of cheaper

10. 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.
 Generic companies are now able to use a patented
drug to establish acts related to FDA approval.

11. HATCH-WAXMAN
EXCLUSIVITY PROVISIONS
 Innovator companies may get “patent term restoration” equal to
delay of approval by FDA, up to 5 years, called “marketing
exclusivity”.
 Innovator companies also get protection of safety and
effectiveness data for 5 years after NDA approval, so-called “data
exclusivity”.
 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
patent expiration).

15. 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.

16. 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.

17. ANDA
(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
resolved.

18.  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.

19. U.S. Department of
Health
and Human Services
Food and Drug
Administration
Center for Biologics
Evaluation and
Research
Center for Devices
and Radiological
Health
Center for Drug
Evaluation and
Research
Center for Food Safety
and Applied Nutrition
Center for Veterinary
Medicine
National Center for
Toxicological Research

20. Generic Drug Review Process
Application
submitted
to Office of
Generic
Drugs
Bioequivalence Review
Plant Inspection
Chemistry/Micro Review
Labeling Review
FDA reviews
and decides if
product is
approved or
not approvable
Determine if application is acceptable
Generic manufacturers do not need to
complete the three phases of clinical trials

24. “PARAGRAPH IV
CERTIFICATION”
 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
basis
 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).

26. 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
ORANGE BOOK”