Impax confirms patent challenge for generic Jalyn

HAYWARD, Calif. — Impax Labs has hit a roadblock in its attempt to market a generic version of a symptomatic benign prostatic hyperplasia drug.

The generic drug maker said that GlaxoSmithKline filed a patent infringement suit against Impax in the District of Delaware last week in connection with its attempt to market dutasteride and tamsulosin hydrochloride 0.5 mg/0.4 mg capsules, a generic version of Jalyn. The suit was filed after Impax submitted an abbreviated new drug application containing a paragraph IV certification for the drug with the Food and Drug Administration.

Once the ANDA is approved by the FDA, Impax’s generic division intends to commercialize the product.

Jalyn, designed to treat symptomatic BPH in men with an enlarged prostate, garnered U.S. sales of about $41 million for the 12-month period ended in July, according to Wolters Kluwer Health data.