Exploring FDA's Orange, Green And Purple Books And Pharmaceutical Patent Strategies
- IJLLR Journal
- Dec 24, 2024
- 1 min read
Anuska Mahto, BBA-LLB (Hons.), ICFAI Law School, Hyderabad
ABSTRACT
The report aims at assessing, in real detailed form, the regulatory frameworks which oversee the approval and listing of the biological products and generic drugs in the United States with a specific focus on the Purple Book, Orange Book, Green Book and Pharmaceutical patents. It clearly explains the different roles and contents of those compendiums, outlines processes involved in submitting an Abbreviated New Drug Application and explains the implications of patent listings and their extensions under current legislation. This would therefore offer an all-round understanding of these regulatory resources for all stakeholders within the pharmaceuticals industry. This report will also include procedure involved in patent listing and will finally conclude by mentioning the further extension period for patents1 under the legislation
Keywords: Orange Book, Pharmaceutical Patents, Purple Book, Green Book, FDA, Hatch-Waxman Act, ANDA process.
