Teva sues FDA after denial of generic Risperdal exclusivity

Kimberly O'Brien — Tue, 25 Mar 2008 15:17:06 +0000

Teva Pharmaceuticals has filed a lawsuit in a U.S. district court against the FDA after being denied the 180-day exclusivity for its generic version of the blockbuster antipsychotic Risperdal. Teva said that it was eligible for the 180-day marketing exclusivity, as it was the first to submit an abbreviated new drug application (ANDA) for Janssen Pharmaceutical’s Risperdal (risperidone) tablets with a Paragraph IV certification for the ’952 patent.

Court invalidates Yasmin patent

Kimberly O'Brien — Tue, 11 Mar 2008 14:31:08 +0000

A U.S. district court has ruled in favor of Barr Pharmaceuticals in a lawsuit challenging the patent listed by Bayer Schering Pharma in connection with Yasmin(R). The judge found the patent for the oral contraceptive as invalid. Yasmin provides an oral contraceptive regimen consisting of 21 active tablets (each containing 3 mg of drospirenone and 0.03 mg of ethinyl estradiol) and 7 inert tablets.

Pharmaceutical Product Guide » Lawsuits

Teva sues FDA after denial of generic Risperdal exclusivity

Court invalidates Yasmin patent