It turns out Teva’s skirmish with the FDA has paid off, or it looks that way. Teva launched generic versions of the drugs Cozaar and Hyzaar on April 6 with 180 days of marketing exclusivity. At one point, Teva’s request for marketing exclusivity looked slim. After a series of courtroom battles, however, this case has taken a number of interesting twists and turns. FDA denied Teva exclusivity on the grounds that Merck had delisted its patent from FDA’s Orange Book. A district court then upheld the agency’s decision, but the U.S. Court of Appeals for the District of Columbia Circuit reversed, finding that a brand company cannot trigger forfeiture of exclusivity by delisting a patent from the Orange Book. Chad Landmon, partner at Axinn, noted that Teva may get the entire benefit of its exclusivity period by the time the court reaches a final decision. Landmon stated that briefing could take a few months at least, and discussed how the D.C. Circuit does not regularly sit over the Summer but that panels will only hear oral argument for emergency matters.

The article, titled, “Teva Launches Generic Cozaar/Hyzaar With Market Exclusivity As FDA Seeks Court Action To Permit Other Entrants,” appeared in The Pink Sheet on April 12, 2010.