HATCH -WAXMAN ACT

Regarding the objectives of the act , drug approval that includes both the branded drug and the generic drug approval, new drug exclusivity, about the challenging patent exclusivity, patent term extension and patent litigation under the act ,and the benefits of branded manufacturers will be discussed here .

1. HATCH-WAXMAN ACT Submitted by:Anu Paul P First year M.Pharm (Pharmaceutics) St.Jame ΄ s c ollege of pharmaceutical sciences,chalakudy

2. CONTENTS Introduction Objectives of the act Drug approval New branded drug approval Generic drug approval New drug exclusivity Challenging patent exclusivity Patent term extension and patent litigation under the act Benefits for branded manufacturers Conclusion Reference

3. INTRODUCTION Hatch- waxman act also known as THE DRUG PRICE COMPETITION AND PATENT TERM RESTORATION ACT. It was enacted in 1984 Before 1962 new drug approval based on safety alone and in 1962 proof of efficacy made compulsory for marketing approval of a new drug Generic companies were required to submit their own comprehensive NDA which were costly and time consuming To overcome above problems ,an act was needed to promote generic companies.

4. OBJECTIVES OF THE ACT Reducing the cost associated with the approval of a generic drug Allowing early – experimental use Motivating the generic drug manufactures

5. DRUG APPROVAL The FDA requires every new drug ,including generic drugs, to be safe and effective Before the adoption of the Hatch-Waxman Act,the FDA required branded and generic drug companies alike to demonstrate the safety and efficacy of their products in the same manner through a NDA The Act changed certain aspects of the NDA process and the new drug’s patent term Hatch –Waxman Act created an abbreviated process to allow generic drug companies to obtain FDA approval of generic drugs .so it is easier for generic drug companies to demonstrate safety and efficacy of their generic drugs.

6. NEW BRANDED DRUG APPROVAL A branded drug company seeking FDA approval to market a new drug must submit an NDA to the FDA . The information provided in the NDA allows the FDA to determine whether : 1) The new drug is both safe and effective 2) Certain other requirements such as labeling and good manufacturing processes

7. GENERIC DRUG APPROVAL The FDA reviews generic drug applications for compliance with the appropriate scientific and regulatory criteria. If an application meets those criteria ,the FDA may grant either: A) Tentative approval B) Final approval Under the Hatch–Waxman Act ,generic drug companies can typically file one of two different kinds of abbreviated applications for approval of a generic drugs: A) An Abbreviated New Drug Application (ANDA) B) A Section 505(b) (2) application , which is often called a paper NDA

8. a) Abbreviated New Drug Applications (ANDA) Under an ANDA ,a generic drug company must establish that the generic drug is effectively a duplicate of the branded,NDA drug ,which is referred to as the Reference Listed Drug(RLD ).The generic drug company must show that the proposed generic drug : a) Has the same active ingredient,route of administration,dosage form strength and intended use as the RLD b) Is bioequivalent with the RLD ,so that it performs in the same manner as the RLD in the body

9. b) Section 505(b)(2)Applications A proposed generic drug may differ in significant ways from the RLD, Under these circumstances, the proposed generic drug must be approved through the section 505(b)(2) paper NDA application process. This application includes less data than an NDA but more data than an ANDA

10. NEW DRUG EXCLUSIVITY A)Non-patent Exclusivities (1) Orphan drug exclusivity , that treats a disease or condition that affects less than 200000 people in the US This exclusivity period is seven years ,but only applies to use in treating the specific rare disease or condition.

11. (2) New chemical entity(NCE)exclusivity This is granted if the FDA has not previously approved the active drug moiety NCE exclusivity bars a generic drug company from filing an application for approval of a generic drug five years from the first approval of the relevant NDA . This exclusivity period is over five years

12. (3) New clinical study exclusivity This applies when new clinical studies lead to new or changed formulations ,dosing regimens or patent population. This exclusivity sometimes called data exclusivity , prohibits the FDA from approving a generic drug application for the new dosage form This exclusivity period is three years

13. (4) Pediatric exclusivity This applies if the FDA requested that the NDA holder conduct studies with the drug in pediatric populations . Pediatric exclusivity adds six months of exclusivity

14. B) Patent exclusivity & the orange book An NDA holder must provide the FDA with the patent number and expiration date of any patent that claims either: The drug ,including the active ingredient and the formulation for the active ingredient A method of using the drug ,but not other inventions such as ; ;- metabolites ;- synthetic intermediates ;- methods of making the drug When the FDA approves the NDA ,the FDA publishes the patent information in the FDA ΄ S Approved Drug Products with Therapeutic Equivalence Determinations publications(orange book)

15. CHALLENGING PATENT EXCLUSIVITY Paragraph 1 certification that no relevant patent is listed in the orange book Paragraph 2 certification that the listed patent has expired Paragraph 3 certification that the listed patent will expire before the requested approval Paragraph 4 certification that the listed patent is invalid

16. PATENT TERM EXTENSION Only one extension can be granted in connection with a particular product, and it must be for a patent that claims either a ; Drug product which means the active ingredient and any approved drug using that active ingredient Method of using a drug product Method of manufacturing a drug product

17. PATENT LITIGATION UNDER THE HATCH-WAXMAN ACT Various time periods concerning aspects of the litigation that may affect the FDA ΄ s approval process Specific remedies the parties tend to seek The generic drug applicant cannot file a declaratory judgment action against the NDA holder for 45 days after the date of the Notice Letter If the patentee sues within the 45-day period ,the FDA may not grant final approval of the generic application for 30 months from the NDA holder and patentees receipt of the Notice Letter(30 month stay)

18. BENEFITS FOR BRANDED MANUFACTURERS Orange book provides public notice of patents 30-month st a y of FDA approval of generic drugs Patent term restoration Allows for several market exclusivities : a) Data exclusivity (1) 5 years for new chemical entity exclusivity (2) 3 years for new clinical study exclusivity b) Orphan drug (7 years) c) Pediatric (6 months )

19. CONCLUSION The Hatch- Waxman A ct provides an expedited USFDA program for speedy generic entry and market exclusivity. The 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 USFDA.

20. REFERENCE h ttps://www.slideshare.in https://en.wikipedia.org