Apotex seeks injunction against GSK, FDA over Paxil

Apotex of Canada's US subsidiary, Apotex Corp, has applied in the USDistrict Court for an injunction against GlaxoSmithKline and the US Food and Drug Administration, seeking the removal of six patents from the FDA's Approved New Drugs with Therapeutic Equivalence Evaluations (the Orange Book).

The action relates to Apotex' attempt to launch a generic version of GSK's antidepressant Paxil/Seroxat (paroxetine), which it says has been delayed almost indefinitely by the patents' listings. Apotex first filed for approval of its generic in 1998, and says that, at that time, it became subject to a lawsuit relating to the only patent on the Orange Book, US Patent No 4,721,723, which covered crystalline paroxetine hydrochloride hemihydrate. Apotex argues that its paroxetine hydrochloride anhydrous drug does not infringe this patent.

The 30-month stay relating to this lawsuit expired on November 21, 2000, but Apotex says it has been unable to launch its product because of successive lawsuits and stays relating to new GSK patents.