The US Supreme Court has rejected an appeal filed by GlaxoSmithKline against Apotex over the latter’s development of a generic version of the blockbuster antidepressant Paxil. Apotex and GlaxoSmithKline’s patent dispute over Paxil dates back to 1998 when SmithKline Beecham sued Apotex for infringing on the patent covering paroxetine.That case went to trial in 2003, with a US District Judge ruling that SmithKline Beecham’s patent was valid. That ruling was later overturned by the Federal Circuit Court. Paxil sales reached $1.1 billion last year.
Valeant Pharmaceuticals won FDA approval to market Zelapar (selegiline HCl) Orally Disintegrating Tablets, a once-daily adjunct therapy for Parkinson's disease patients being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this therapy.
The FDA approved the expanded indication of GlaxoSmithKline’s ovarian and lung cancer drug Hycamtin (topotecan HCI), as a treatment for advanced cervical cancer. Hycamtin was initially approved to treat ovarian cancer in 1996 and small-cell lung cancer in 1998.
Teva Pharmaceutical said yesterday that the FDA has approved its generic version of Merck’s Proscar (finasteride) for enlarged prostates. Teva will have six months of marketing exclusivity on its 5 mg. tablet form of the drug.