GlaxoSmithKline (NYSE:GSK) enlarged prostate drug Jalyn faces the prospect of generic competition just over a year after launching in the U.S. market.
Generic drug maker Watson Pharmaceuticals (NYSE:WPI) has filed an abbreviated new drug application with the U.S. Food and Drug Administration seeking to market its version of Jalyn, which is used to treat symptomatic benign prostatic hyperplasia (BPH) – a treatment enlarged prostate glands. A Jalyn generic could fit in with Watson’s portfolio, which includes branded products focused on urology.
In response to Watson’s application, GSK, which has its U.S. headquarters in Research Triangle Park, North Carolina, has filed a suit against Watson in federal court in Delaware to prevent the company from marketing its generic Jalyn product before its first patent expires in 2013. Under the law, the suit will result in a stay of approval of Watson’s application until December 30, 2013 or until the court resolves the matter, whichever comes first. Jayln’s patents start to expire in September 2013.
GSK received FDA approval for Jalyn in June 2010.The combination drug pairs GSK’s dutasteride with tamsulosin. Dutasteride, an FDA-approved product marketed under the name Avodart, treats BPH symptoms and shrinks the prostate over time. Tamsulosin treats the signs and symptoms of BPH and works by relaxing the muscles in the bladder and prostate.
Watson is also pursuing a generic version of Avodart, which GSK has also taken measures to block. Since receiving FDA approval last year, Jalyn had U.S. sales of more than $30 million through May 31, according to figures from IMS Health. Avodart had U.S. sales of $580 million for the 12 months ending April 30, according to IMS figures.
