Hatch Waxman Act by Anamika Dey

Hatch Waxman Act is a topic of Regulatory Affairs.

1. HATCH-WAXMAN ACT PRESENTED BY- ANAMIKA DEY ROLL NO- MPH/10009/19

2. CONTENTS INTRODUCTION OBJECTIVES OF THE ACT NEW DRUG APPROVAL GENERIC DRUG APPROVAL CHALLENGING PATENT EXCLUVITIES ANDA EXCLUSIVITY PATENT TERM EXTENSION BENEFITS FOR BRANDED DRUG MANUFACTURERS LOOPHOLES OF THE ACT CONCLUSION

3. INTRODUCTION It is also known as “ The drug price competition and patent term restoration act”. It was proposed by Orrin Hatch and Henry A. Waxman. Effective since 24 September, 1984 It facilitated the growth of generic industry The bill altered the pharmaceutical industry substantially as it established government regulations for generic drugs in the United States and made it a lot easier for generic drugs to enter the market.

4. Objectives of the act The original intent of the act was to increase generic drug availability in the market and make drugs more affordable. The act sought to achieve the objective of increasing competition with the introduction of a greater number of generic drugs in timely manner and rewards innovators with increased patent terms during which they enjoy market exclusivity. The Hatch Waxman Act amended the FD&C Act and created Abbreviated New Drug process to submit generic drugs to the FDA for approval. It also compensates the branded drug manufacturers for the time lost from the patent term because of the regulatory approval formality.

5. NEW DRUG APPROVAL The FDA requires every new drug to be safe and effective. A branded drug company seeking FDA approval to market a new drug must submit an NDA (New Dug Application) to FDA. The information provided in the NDA allows FDA to determine whether: 1) The new drug is safe and effective 2) Certain other regulatory requirements are met, such as those concerning good manufacturing practices. Obtaining and submitting this information is a time consuming process as it requires many extensive and clinical trials.

6. GENERIC DRUG APPROVAL Under the HATCH-WAXMAN Act, generic drug companies can typically file an ANDA (Abbreviated New Drug Application) to FDA. Generic drug applications are required to prove that they are therapeutically equivalent to innovator drugs. This is accomplished by demonstrating: Bio equivalence Pharmaceutical equivalence Compliance with cGMP requirements

7. Generic drugs were also required to include certifications of the status of all patents to the reference innovator drug. Accordingly the generic submission are categorized as: PARAGRAPH I FILINGS : No patent information has been previously submitted to the FDA. PARAGRAPH II FILINGS : All the submitted patents relevant to drug have expired. PARAGRAPH III FILINGS : If the applicant states that he intends to market the drug only after the expiry of the listed patents. PARAGRAPH IV FILINGS : If the applicant certifies that any product or used patent is invalid or will not be infringed by the generic drug approval. Challenging patent exclusivity

8. Anda exclusivity The first filer of ANDA with a Paragraph IV Certification concerning an reference listed drug (RLD) is potentially entitled to a 180 day period during which the FDA will not approve any other ANDA having a Paragraph IV certification for a generic version of RLD. Thus, first filer exclusivity blocks final approval of other ANDAs with Paragraph IV certification for 180 days.

9. PATENT TERM EXTENSION The Hatch WAXMAN Act provides a patent term extension for patents covering certain products including human drug products, that are subject to FDA approval. Only one extension can be granted in connection to a particular product, and it must be for a patent that claims either a: A) Drug product, that is, the active ingredient and any approved drug using that active ingredient. B) Method of using that drug product C) Method of manufacturing a drug product

10. Benefits for branded manufacturers Orange book provides public notice of patents drugs. Allows for resolution of patent disputes prior to generic entry. 30 months stay of FDA approval of generic Patent term restoration. Allows for several market exclusivities A)Data Exclusivity- 1) 5 years for new chemical entity 2) 3 years for new clinical study exclusivity B)Orphan drug(7 years) C)Pediatric drug(6 months)

11. LOOPHOLES OF THE ACT AUTHORIZED GENERICS- They are pharmaceutical products that are approved as brand-name drugs but marketed as generic drugs. Authorized generics do not bear the trademark of the manufacturer but are manufactured to the brand’s specifications. WAREHOUSING PATENTS- An innovator may patent multiple attributes of a product (may be color, manufacturing process), essentially forcing the generic to hose between waiting for the patents to expire or file a para IV litigation and associated costs and delays.

12. CONCLUSION The HATCH WAXMAN Act provides an expedited USFDA program for speedy generic entry and market exclusivity. The HATCH WAXMAN Act allows for a patent term extension of a maximum of 5 years for the branded drug manufacturer to compensate for the time lost during the NDA approval by the US FDA.