Generic Drugs:  Overview of ANDA Review
Process
Ted Sherwood
Office of Pharmaceutical Science
Brand vs. Generic
G et
F eel
B etter
B etter
What is the Main Consumer
Concern Regarding Generics?
z Do the quality and performance of
generic drugs compare to brand drugs?
Often triggered by brand companies
and physicians
Legislative History
z1906 Pure Food and Drug Act -establishes regulation of Food and Drugs
z1938 Food, Drug and Cosmetic Act -introduced safety standards
z1962 Kefauver-Harris Amendments to the FDA&C Act -tightened safety standards and introduced requirement that drugs must be effective
z1984 Hatch-Waxman Act -created an abbreviated mechanism for approval of generic copies of all drugs
originally approved after 1962, by stating that pre-clinical and clinical testing did not have to be repeated for generics
Definition of a Generic Drug
A drug product that is comparable to a
brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use.
When can a Generic Drug
be Marketed?
z After patent & exclusivity protection ends, or z patent owner waives its rights, and
z FDA requirements are met
Patent Protection
• 17 years from the date the patent was issued
or
• 20 years from the date the patent was submitted (to the Patent Office, not FDA)
Equates to approximately 12 years
of marketing protection.
Patent Filing
Granted by U.S. Patent and Trademark Office
Submitted to/for NDAs only
Covers
Drug Substance – Active Ingredient
ignore subsequent bad blocks
Method of Use – Indication
Drug Product – Formulation, Composition
Published in Orange Book
Delays final approval date of ANDAs
Approximately 240 patents listed in Orange Book
will expire in the next 5 years
Patent Certification
I Patent Not Submitted to FDA -approval effective after OGD scientific determination
II Patent Expired -approval effective after OGD scientific determination
III Patent Expiration Date (honored) – tentative approval after OGD scientific determination, final approval when patent expires
IV Patent Challenge – tentative approval after OGD science determination, final approval when challenge won
Patent Challenge Process
Paragraph IV certification by ANDA holder declaring patent invalid, not infringed, or not enforceable
Notification provision on ANDA holder
45-Day clock
No lawsuit – challenge successful
Lawsuit – 30 months (risk of marketing after
meeting FDA approval criteria) or final court
decision, whichever earlier

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