PARSIPPANY, N.J. — Watson Pharmaceuticals is hoping to be the first to market a generic version of a GlaxoSmithKline drug for men with an enlarged prostate, Watson said.
Watson announced that it filed a regulatory approval application to market a generic version of GSK’s Jalyn (dutasteride and tamsulosin hydrochloride) capsules, a treatment for symptomatic benign prostatic hyperplasia in men with enlarged prostates.
Watson’s filing contained a Paragraph IV certification, a legal assertion that patents covering Jalyn are invalid, unenforceable or won’t be infringed. In response, under the Hatch-Waxman Act of 1984, GSK filed suit against Watson to try and prevent it from commercializing the drug before the expiration of U.S. Patent No. 5,565,467, which will occur in November 2015.
Jalyn had sales of more than $30 million during the 12-month period ended in May, according to IMS Health.