Generics Challenge FDA's Decision On Pfizer Drug

Apparently not too many companies other than Pfizer (PFE) are happy with the FDA's decision last week regarding Norvasc (amlodipine besylate) exclusivity.

On Monday, Mylan (MYL), Apotex, and Teva (TEVA) all filed motions with the U.S. District Court for the District of Columbia for injunctive relief from FDA's decision.  Yesterday, everyone filed briefs in opposition to each others' motions.

Mylan, currently the only generic on the market, is unhappy that FDA intends to approve Apotex's ANDA if and when the Federal Circuit issues a mandate from its March 22 decision.  Apotex, who won that decision, wants final approval of its ANDA now--and Mylan's approval revoked.  Teva, another ANDA applicant for amlodipine, argues that all ANDA applicants should be granted final approval.

Here are the briefs: (pdf files)

• Mylan motion for preliminary injunction
• Apotex motion for preliminary injunction
• Teva motion for injunctive relief
• FDA opposition to all motions
• Mylan opposition to Apotex motion
• Mylan opposition to Teva motion
• Apotex opposition to Mylan motion
• Apotex opposition to Teva motion
• Mutual Pharma opposition to Apotex and Teva's motions

Considering the expedited briefing schedule and the fact that one month of Pfizer's six-month pediatric exclusivity period has already elapsed, I would expect to see a ruling from the district court sometime next week.  Given how much money is at stake in this case (Norvasc had sales of $2.5 billion in the U.S. last year), any decision is likely to be appealed.