Mylan launches generic Paxil CR

PITTSBURGH Mylan today began launching its new drug, paroxetine hydrochloride extended-release tablets, the generic of GlaxoSmithKline’s Paxil CR.

The company now has 180 days of market exclusivity for the two of the drug’s strengths, 12.5 and 25 mgs. Mylan and GSK have also reached a supply and distribution deal that will allow Mylan to market the 37.5 strength as well.

“As another first-to-file opportunity, paroxetine HCl ER reflects Mylan’s continued dynamic speed-to-market capabilities,” says Robert Coury, Mylan’s vice chairman and chief executive officer. “Because this product also belongs in the ‘difficult- to-manufacture’ category, it is yet another example of our historically strong research and development process, through which we’re able to deliver affordable versions of important complex therapies. Our settlement with GSK is consistent with our commitment to monetize opportunities when it benefits both patients and our shareholders.”

Paxil CR had sales in the U.S. of about $301 million for the 12 months ending March 31, 2008, for all three strengths.