Generic player Mylan announced (in a press release Here) that its subsidiary Mylan Pharmaceuticals Inc. has entered into settlement and license agreements with Wyeth, now part of Pfizer, relating to Venlafaxine HCl (Effexor XR) 37.5, 75 and 150 mg Capsules.
Following patents are listed in Orange Book w.r.t Venlafaxine HCl (Effexor XR) 37.5, 75 and 150 mg Capsules:
US6274171 (Expiry: September 20, 2017) Link
US6403120 (Expiry: September 20, 2017) link
US6419958 (Expiry: September 20, 2017) Link
US4535186 (Expiry: June 13, 2008) Link
US5916923 (Expiry: December 28, 2013) Link
US6444708 (Expiry: December 28, 2013) Link
Earlier, innovator Wyeth had sued Mylan for the infringement of ‘171, ‘120 and ‘958 patents in the West Virginia North District Court in 2007.
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 XR Capsules in the U.S. on or after June 1, 2011, or earlier in limited circumstances. Additional details of the agreement remain confidential.
Earlier, innovator had settled with generic players like Impax, Osmotica, Wockhardt, Sun pharma, Lupin, Anchen and Teva on this product.
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.
Venlafaxine extended release is chemically the same as normal venlafaxine. The extended release version (sometimes referred to as controlled release) controls the release of the drug into the gastrointestinal tract over a longer period than normal venlafaxine. This results in a lower peak plasma concentration. Studies have shown that the extended release formula has a lower incidence of patients suffering from nausea as a side effect resulting in a lower number of patients stopping their treatment due to nausea.
(Source: the report is based on Mylan press release and some earlier posts of IP Pharma Doc on this product)
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