Mylan Announces Settlement of Paroxetine Hydrochloride Extended-Release Tablets with GlaxoSmithKline
PITTSBURGH, Oct. 23 -- Mylan Inc. today 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(R). 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."
This press release includes statements that constitute "forward-looking statements," including with regard to the settlement, Mylan's entry into the market and marketing exclusivity. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: any legal or regulatory challenges to the settlement; the possibility that other ANDAs have been filed; and the other risks detailed in the Company's periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release.
Mylan Inc. is one of the world's leading quality generic and specialty pharmaceutical companies. The Company offers one of the industry's broadest and highest quality product portfolios, a robust product pipeline and a global commercial footprint through operations in more than 90 countries. Through its controlling interest in Matrix Laboratories Limited, Mylan has direct access to one of the largest active pharmaceutical ingredient (API) manufacturers in the world. Dey L.P., Mylan's fully integrated specialty business, provides the Company with innovative and diversified opportunities in the respiratory and allergy therapeutic areas.