Mylan Inc. announced that Mylan Pharmaceuticals Inc. has launched Paroxetine Hydrochloride (HCl) extended-release (ER) tablets, the generic version of GlaxoSmithKline's (GSK) Paxil CR.
As the first company to successfully file an abbreviated new drug application (ANDA) containing a paragraph IV certification for the 12.5 mg and 25 mg tablets, Mylan has earned 180 days of marketing exclusivity for these two strengths. Reflecting a supply and distribution agreement with GSK, Mylan also has the right to market the 37.5 mg strength. Mylan is not aware of any other ANDA filers with paragraph IV certifications for this product.
"As another first-to-file opportunity, Paroxetine HCl ER reflects Mylan's continued dynamic speed-to-market capabilities," says Robert J Coury, Mylan's vice chairman and CEO. "Because this product also belongs in the 'difficult- to-manufacture' category, it is yet another example of our historically strong R&D 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."
Paroxetine HCl ER tablets had US sales of approximately $301 million for the 12 months ending March 31, 2008, for all three strengths.
In October 2007, Mylan announced the settlement of patent litigation involving Paroxetine HCl ER. At that time, Mylan stated that the settlement would provide the company with patent licenses and the right to market all three strengths beginning no later than October 1, 2008. As part of the settlement agreement, which remains confidential, Mylan has been provided with the patent licenses needed to distribute the product immediately.