The nexus between NDA filings, Orange Book listings and Market Exclusivity

CHAL 36

Melvin Winokur, mwinok@optonline.net, Merck & Co, P.O. Box 2000, Rahway, NJ 07065
Under the provisions of Hatch-Waxman an NDA filing requires the submission of certain patent information. Patents which claim the drug, or a method of using a drug, for which approval is being sought should be listed. Types of patents to list, procedures for submission and the resultant patent exclusivity consequences of the listing will be covered in the presentation. Possible data exclusivity arising from an NDA filing will also be covered.