Paroxetine hydrochloride (HCl) extended-release (ER) tablet is a 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 12.5mg and 25mg 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 37.5mg strength. Mylan is not aware of any other ANDA filers with paragraph IV certifications for this product.
Robert Coury, Mylan’s vice chairman and CEO, said: “As another first-to-file opportunity, Paroxetine HCl ER reflects Mylan’s continued dynamic speed-to-market capabilities. Our settlement with GSK is consistent with our commitment to monetize opportunities when it benefits both patients and our shareholders.”