FDA backs Mylan on generic Norvasc

FDA backs Mylan on generic Norvasc

	Published : Thu, 19 Apr 2007 23:39 By : Agencies Print this Story

WASHINGTON (AP) - Government regulators have notified Mylan Laboratories that it is the only generic drug company permitted to sell cheaper versions of Pfizer's blood pressure medicine, Norvasc.

The Food and Drug Administration posted a letter to its Web site Thursday, saying generic drug makers except Mylan are prohibited from selling generic versions of Norvasc for six months.

The agency awards six months of exclusive marketing privileges to the first generic drug company to file an application on a drug near patent expiration. Mylan launched its generic version late last month after Pfizer's Norvasc patent expired.

Even though Pittsburgh-based Mylan claims it has marketing exclusivity through September, the resolution of a legal dispute could jeopardize that position.

There are two ways a generic drug maker can gain six-month marketing exclusivity when a patent nears expiration. One is to be the first to file for regulatory approval and the other is to successfully challenge the validity of the drug's patent in court.

Last month, the U.S. Court of Appeals for the Federal Circuit reversed a decision in which privately held generic drug maker Apotex claimed Pfizer's Norvasc patent was invalid.

The court has not yet formally issued a mandate on its decision, but when it does, Apotex may still have a shot at launching a generic Norvasc before Mylan's six-month exclusivity period ends, the FDA says.

Apotex did not immediately return calls placed for this story.

Before Mylan filed for regulatory approval, it had tried and failed in court to challenge Pfizer's patent on Norvasc, which had sales of $4.86 billion last year.

Analysts said the FDA's decision is a partial victory for Mylan, but the possibility of other generic competition dampened Wall Street's reaction.

'Although the FDA opinion appears positive for Mylan, our view remains that its shares already reflect the full opportunity and there is downside potential to our forecasts if additional generics arrive before September,' said Citigroup analyst Andrew Swanson.

Shares of Mylan Laboratories rose 5 cents Thursday to $21.93 in after hours trading, following an earlier close at $21.88, up 2 cents, on the New York Stock Exchange. Pfizer Inc. fell 18 cents to $26.89 in after hours trading, ending the day down 29 cents to $27.07, also on NYSE.