PHARMACY

Teva files lawsuit against FDA for generic Risperdal exclusivity

BY Diana Alickaj

WASHINGTON Teva Pharmaceutical Industries announced that it filed a lawsuit against the Food and Drug Administration to seek an order for the FDA to grant the company an 180-day exclusivity for its generic version of Risperdal.

Risperdal is used for the treatment of schizophrenia and, according to published reports, shows annual sales of $3.5 billion. Teva is ordering through the lawsuit that the FDA re-list in the Orange Book US Patent No. 5,158,952, in which it submitted its generic version known as risperidone in 2001.

The denial of Teva’s Citizen’s Petition to re-list the patent by the FDA was seen as unlawful by Teva, and since it was the first to challenge the patent for the drug in 2001, the company felt that it should inherit the 180-day exclusivity period for its genetic version. However, the FDA disputes that since it removed the patent from the orange book in 2001, the submission also fell, and, in effect, its request was not valid.

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Possible new FDA diabetes drug guidelines could delay approvals

BY Drew Buono

SAN DIEGO A draft of new guidelines proposed by the Food and Drug Administration for developing drugs to treat diabetes may lead to a delay of the approval for a new long-acting diabetes drug from Amylin Pharmaceuticals, according to the Associated Press.

The FDA suggested increased testing for macrovascular complications, or diseases affecting large veins, particularly for drugs that are linked to problems with those veins.

That could delay approval of Amylin’s diabetes drug candidate exenatide LAR, a weekly version of its Byetta treatment and a Type 2 injectable diabetes drug, which it co-manufactures with Eli Lilly, Lazard Capital Markets analyst Matthew Osborne wrote in a note to clients Monday. He said the guidelines could make clinical trials of diabetes drugs more expensive and difficult.

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FDA approves Ranbaxy’s generic version of Risperdal

BY Drew Buono

NEW DELHI, India Ranbaxy Laboratories has received approval from the Food and Drug Administration for a generic version of Janssen Pharmaceuticals’ schizophrenia drug, Risperdal, according to published reports.

Risperdal is also used to treat such behavior problems as aggression and self-injury, as well as sudden mood changes in teenagers and autism in children. The company has received approval to launch the generic risperidone in 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg strengths.

Risperdal had sales of $924 million in 2007.

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