Impax Laboratories, Inc. (NASDAQ: IPXL) today confirms that it has initiated a challenge of the patents listed in connection with JALYN® (dutasteride and tamsulosin hydrochloride 0.5 mg/0.4 mg) capsules.
Impax filed its Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic version of JALYN® with the U.S. Food & Drug Administration (FDA). Following receipt of the notice from FDA that Impax's 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 product.
On September 8, 2011, GlaxoSmithKline LLC filed suit for patent infringement against Impax in the District of Delaware. This action formally initiates the patent challenge process under the Hatch-Waxman Act.
Once the ANDA is approved by FDA, Global Pharmaceuticals, Impax's generic division, intends to commercialize the product.
JALYN® is indicated for the treatment of benign prostatic hyperplasia in men with an enlarged prostate. According to Wolters Kluwer Health, U.S. sales of JALYN® were approximately $41 million for the twelve-month period ending July 2011.