NEW YORK (AFX) - Drug developer Unimed Pharmaceuticals Inc. said late Wednesday it settled a multifaceted patent dispute over its testosterone gel, AndroGel, used to treat a testosterone deficiency condition.
The company, a subsidiary of Brussels-based Solvay Pharmaceuticals Inc., settled with Corona, Calif.-based Watson Pharmaceuticals Inc, Woodcliff Lake, N.J.-based Par Pharmaceutical Companies Inc., and privately held, Minneapolis-based Paddock Laboratories.
Par entered into a licensing agreement with Paddock to market a generic version of the drug in 2003, after Paddock had filed an application to make the generic. Under the agreement, Par paid Paddock $6 million for all rights to its application. Solvay will grant Par a non-exclusive license to market the generic beginning no later than Feb. 26, 2016. That's over four years before the patent's expiration date.
That patent expiration date was the key subject in the lawsuits.
Also under the settlement, Watson will hold off on marketing its FDA-approved generic version until Aug. 31, 2015, and forfeit its 180-day marketing exclusivity period.
Hypogonadism, also known as low testosterone, is one of the top 10 most prevalent conditions seen by urologists. In fact, it is estimated that low T affects up to 13 million American men aged 45 years and older. AndroGel is a once-daily, clear, odorless, topical testosterone gel indicated for replacement therapy in men for conditions associated with a deficiency or absence of endogenous testosterone.
Shares of Watson closed unchanged at $26.09 on the New York Stock Exchange and shares of Par rose 15 cents to close at $19.13 on the Big Board.
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