Synthon, Teva to Market Generic Norvasc

Synthon and Teva Pharmaceutical have received FDA approval to market generic versions of Pfizer’s Norvasc. Mylan Pharmaceuticals and Apotex had been the first to receive abbreviated new drug application approval for the hypertension drug.

Both companies plan to market 2.5-, 5- and 10-mg generic Norvasc (amlodipine besylate) tablets, Synthon and Teva said.

The U.S. Court of Appeals for the Federal Circuit ruled June 5 to reverse a decision by the U.S. District Court for the Western District of Pennsylvania that upheld Pfizer’s claims that the ’303 patent covering Norvasc. The federal appeals court held the three main claims in the patent are invalid.

Mylan had launched its product the day after a March 22 ruling by the federal appeals court — in a separate case brought by Pfizer against Apotex — that the ’303 patent is invalid and unenforceable. Apotex launched generic Norvasc May 24 when the FDA approved its product after the federal court issued a mandate of its March decision.