Mylan Pharmaceuticals signs settlement and license agreements with Wyeth

Mylan Inc. (Nasdaq: MYL) today 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 U.S. on or after June 1, 2011, or earlier in limited circumstances. Additional details of the agreement remain confidential.

Venlafaxine HCl ER Capsules had U.S. sales of approximately $2.9 billion for the same strengths for the 12 months ending Sept. 30, according to IMS Health. Currently, Mylan has 129 abbreviated new drug applications (ANDAs) pending U.S. Food and Drug Administration approval representing $85 billion in annual brand sales, according to IMS. Thirty-seven of these pending ANDAs are potential first-to-file opportunities, representing $19.2 billion in annual brand sales, according to IMS.