FDAnews Drug Daily Bulletin

Cobalt Drops Suit Against FDA

May 28, 2008

Cobalt has voluntarily dismissed a lawsuit in which it had asked a court to restore its marketing exclusivity for a generic version of Bayer Pharmaceutical’s diabetes drug Precose.

In a one-paragraph document, the company said it was dismissing the case against the FDA without prejudice. Cobalt had brought the suit May 8 in the U.S. District Court for the District of Columbia, alleging the agency had unlawfully forfeited the company’s 180-day marketing exclusivity for a generic version of Precose (acarbose).

Cobalt had maintained that it was the first company to file an ANDA with a Paragraph IV certification on the drug’s ’769 patent, which has been delisted from the Orange Book. However, the FDA informed Cobalt May 7 that it had forfeited its right to generic exclusivity.

Cobalt said in court documents the FDA acknowledged its actions had delayed the company’s ability to market the product, but the agency said Cobalt had forfeited its exclusivity because it failed to obtain final approval and launch within 30 months of its 2005 ANDA submission.

Cobalt asked the court to enjoin the agency from approving all other ANDAs for the drug “until natural expiration of Cobalt’s statutory right to exclusivity for its acarbose ANDA.” It also requested that the FDA stay or withdraw approval for other acarbose ANDAs, including one from Boehringer Ingelheim’s subsidiary Roxane, which the agency approved May 7. Finally, it asked the court to order the FDA to recall any acarbose product made by Roxane on the market.

The court declined to issue a temporary restraining order against Roxane, finding that under the language of the Food, Drug and Cosmetic Act, Cobalt was unlikely to prevail in the case and Roxane would suffer “significant competitive injury,” Zuckerman Spaeder, the law firm representing Roxane, said.