Celebrex Generics: Will Any Qualify For 180-Day Market Exclusivity?
This article was originally published in The Pink Sheet Daily
Executive Summary
Last patent covering Pfizer’s pain drug is a reissue of an earlier patent on which 180-day exclusivity has already been triggered; FDA has previously declined to award exclusivity to such patents.
You may also be interested in...
Celebrex Reissue Patent Reawakens Generic Litigation
Pfizer sues five generic firms alleging their celecoxib ANDAs infringe a reissued method-of-use patent, which protects the blockbuster COX-2 inhibitor until December 2015, 18 months longer than had been expected.
Companies Reveal Hurdles In Providing Drugs Via Expanded Access Programs
GSK, Stealth BioTherapeutics and Blueprint Medicines discuss the difficulties getting participation of physicians, the excessive cost of expanded access, and whether physicians should report research data.
Current Pathways For Rare Disease Drugs Are Not Optimal, US FDA’s Califf Says
Anticipating a ‘tsunami of therapies’ for rare diseases, commissioner says the agency will have to think of creative approaches and employ regulatory flexibility for them. FDA considers copying the oncology center’s Project Facilitate for expanded access to other diseases.