Sun Pharma receives FDA approval for generic Trileptal

Sun Pharmaceutical Industries has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) to market its generic version of Novartis Trileptal -oxcarbazepine tablets.

The generic tablets are an AB-rated equivalent of Norvartis Trileptal tablets and come in 150mg, 300mg and 600mg strengths.

Currently this range of Trileptal tablets have annual sales of $640 million (320 million pounds) in the US.

Sun Pharma also received 180 day marketing exclusivity due to being the first-to-file ANDA with a paragraph IV certification.

Currently no action has been taken over patent infringement of the generic tablets and the company expects to market the products shortly.

Gary J Buehler, director of FDA’s office of generic drugs, explained the basis for the decision: “FDA requires generic drugs to have the same quality, strength, purity and stability as brand-name drugs.”

He added: “The agency ensures that generic drugs are safe and effective, offering alternatives to Americans in choosing their prescription drugs.”

Last month, moves by Wyeth and its business partner Nycomed to take out a preliminary injunction against Teva Pharmaceuticals and Sun Pharmaceuticals was rejected by the United States District Court for the District of New Jersey.