Impax confirms patent challenge to GlaxoSmithKline's Jalyn; Albemarle hikes API prices

US generic drugmaker Impax Laboratories (Nasdaq: IPXL) confirms that it has initiated a challenge of the patents listed in connection with UK pharma giant GlaxoSmithKline’s Jalyn (dutasteride and tamsulosin hydrochloride 0.5mg/0.4 mg) capsules, indicated for the treatment of benign prostatic hyperplasia (BPH) in men with an enlarged prostate.

Impax filed its Abbreviated New Drug Application containing a Paragraph IV certification for a generic version of Jalyn with the US Food and Drug Administration. Following receipt of the notice from FDA that Impax’ ANDA had been accepted for filing, Impax notified the New Drug Application holder and patent owner of its Paragraph IV certification. Impax and its partner Banner Pharmacaps jointly developed the copy product.

GSK filed suit for patent infringement against Impax in the District of Delaware on September 8, thus formally initiating the patent challenge process under the Hatch-Waxman Act. The UK company also filed suit against Impax, as well as Mylan Labs, for infringement of the patent relating to its single-agent prostate drug Avodart (dutasteride), approved and marketed to treat the symptoms of BPH.