Mylan Inc announced that its subsidiary Mylan Pharmaceuticals Inc has entered into settlement and license agreements with Wyeth, now part of Pfizer, relating to Venlafaxine Hydrochloride (HCl) Extended Release (ER) Capsules, 37.5 mg, 75 mg and 150 mg, the generic version of Wyeth's Effexor XR Capsules, a treatment for major depressive disorder.
Pursuant to the license agreement, Mylan will be granted a non-exclusive license to the relevant patents that would permit Mylan to launch Venlafaxine HCl ER Capsules in the US on or after June 1, 2011, or earlier in limited circumstances. Additional details of the agreement remain confidential.
Venlafaxine HCl ER Capsules had US sales of approximately US$ 2.9 billion for the same strengths for the 12 months ending September 30, according to IMS Health. Currently, Mylan has 129 abbreviated new drug applications (ANDAs) pending US Food and Drug Administration approval representing US$ 85 billion in annual brand sales, according to IMS. Thirty-seven of these pending ANDAs are potential first-to-file opportunities, representing US$ 19.2 billion in annual brand sales, according to IMS.
Mylan ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 140 countries and territories.