Tuesday, November 07, 2006

Fulvestrant Expiring in December 2007, not October 2006

Fulvestrant, an antiestrogen drug used in the treatment of certain types of breast cancer in postmenopausal women marketed by AstraZeneca under the brand name Faslodex, is disclosed in U.S. Patent # 4,659,516 (the ‘516 patent) which was expected to run-out patent protection on October 01, 2006 (including 2 years patent term extension. But according to the current information available at Orange Book, Fulvestrant will be going off-patent on December 11, 2007. However, it is not sure why Fulvestrant patent expiry got revised from October 2006 to December 2007 but FDA docket refers to a document where AstraZeneca attorney has requested USFDA for reconsideration and revision of the Regulatory Review Determination under § 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)). Drugs expired in October 2006 Nedocromil Sodium expired on October 02, 2006 Zolpidem Tartrate expired on October 21, 2006


  1. US 4,659,516 patent was granted patent term extension of 1,166 days on Sep 15, 2006, and according to orange book the patent expiry is correct i.e Dec 2007.

  2. Orange book has provided accurate data for patent expiry. 3 years 2 month and 11 days were added to actual expiry date.

  3. Patent had received 1166 addition days to actual expiry date.
    Means 11 days 2 months and 3 years need to be add in actual expiry date.