FDA to Decide Who Gets Marketing Exclusivity for Generic Norvasc

The FDA is set to make a decision this week that could determine who gets to market generic Norvasc with six months of exclusivity.

Following a federal court order blocking several other abbreviated new drug applications (ANDAs) to manufacture and market amlodipine besylate, the active ingredient in Pfizer's hypertension treatment Norvasc, the federal agency promised it would have an answer by April 11.

Earlier the U.S. Court of Appeals for the Federal Circuit found the basic '303 patent invalid in a legal action brought by Apotex. The decision was handed down days before the patent expired. But it was competing generic firm Mylan Laboratories that immediately launched its own version of the drug with exclusivity.

Last week, several interested parties submitted more than a dozen letters to the FDA calling for the agency to give the green light to pending ANDAs submitted by other generic firms also looking to market their versions of the blood-pressure drug. They said final FDA approval should be granted because the basic Norvasc patent was found invalid by a federal appeals court and the patent has now expired.

A key issue, according to the FDA's request for comments, is the question of exclusivity and whether other generic firms should continue to be denied market entry for the full 180 days of marketing exclusivity beyond the patent's expiration date.

The majority of respondents, most of which are generic drug manufacturers, said that Pfizer and Mylan are not entitled to marketing exclusivity and that all tentatively approved ANDAs should be granted final approval once the federal court issues a mandate.

The federal appeals court is expected to make its ruling April 13. ( http://www.fdanews.com/did/6_71/ )