Mylan Inc. has announced that it and its subsidiary Mylan Pharmaceuticals Inc. have entered into a patent license and settlement agreement with GlaxoSmithKline (GSK) relating to Paroxetine Hydrochloride (HCl) Extended-release (ER) Tablets, the generic version of GSK's Paxil CR.
All litigation between Mylan and GSK relating to Paroxetine HCl ER Tablets will be dismissed with prejudice.
Under the agreement and an associated supply and distribution agreement, Mylan is provided patent licenses and the right to market all three strengths of Paroxetine HCl ER Tablets, 12.5 mg, 25 mg and 37.5 mg, beginning no later than Oct. 1, 2008. Paroxetine HCl ER Tablets had U.S. sales of approximately $342 million for the 12 months ending June 30, 2007, for all three strengths.
Mylan was the first company to file an ANDA containing a paragraph IV certification covering the 12.5 mg and 25 mg strengths. Upon receipt of final approval from the U.S. Food and Drug Administration on June 29, 2007, Mylan became eligible for a 180-day period of marketing exclusivity for these two tablet strengths.
Robert J. Coury, Vice Chairman and CEO of Mylan stated, "Consistent with our commitment to monetize on our first-to-file opportunities and continuing to meet our commitment to bring affordable pharmaceuticals to the consumers who need them, we are extremely pleased to have reached this agreement with GSK. This is especially gratifying as we continue to add another very difficult to develop and/or manufacture product to our portfolio."