As I wrote last week, on 4/9/12 the FDA denied ViroPharma’s request for 3-year exclusivity for its antibiotic Vancocin and approved three generics. ViroPharma immediately sued the heads of FDA and HHS and their Agencies. In a U.S. District Court decision, the judge denied ViroPharma’s motions to grant a preliminary injunction to require that FDA withdraw the ANDA approvals and prevent further approvals until a full court review of the FDA decision.
I’d like to make it clear that this issue is limited to antibiotics. Antibiotics were regulated under section 507, not 505, so they didn’t get the exclusivity provisions of the 1984 Hatch-Waxman amendment. This was addressed later when 507 was abolished and antibiotics were folded into 505 withe the caveat that exclusivity only is gained when a new use of the antibiotic is being requested.
A Camargo, we have 2 examples in progress. In both examples, the clients are developing completely new indications for very old antibiotics. Both will get exclusivity upon approval.