Venlafexine XR (Effexor XR): Innovator Wyeth settled with Impax

It’s settlement season between innovator and generic companies, after settlement with Sun pharma (convenant not sue for their ANDA on Venlafexine XR tablets), Teva (Venlafexine XR capsules) and Osmotica (Venlafexine XR tablets), innovator Wyeth settled with another generic player on Venlafexine XR capsules. In a press release, Wyeth and generic player Impax Lab have announced settlement of the patent infringement litigation pertaining to Impax's copycat version of Venlafexine XR Capsules, the settlement have been approved by the District Court of Delaware. The Court entered a consent judgment resulting in termination of the litigation effective July 16. Following patents are listed in Orange Book w.r.t Venlafexine XR 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

The Impax was in litigation with innovator for the infringement of ‘171, ‘120 and ‘958 patents. The litigated patents covers extended release dosage formulation and unit dosage form thereof of venlafaxine hydrochloride, an antidepressant, which provides better control of blood plasma levels than conventional tablet formulations which must be administered two or more times a day and further provides a lower incidence of nausea and vomiting than the conventional tablets.
Under the terms of the settlement, Wyeth has granted Impax a license that would permit Impax to launch its capsule formulation of Effexor XR on or after June 1, 2011, subject to earlier launch in limited circumstances, but in no event earlier than January 1, 2011. Further, Impax will pay Wyeth some royalty.USFDA approved NDA of wyeth for 37.5, 75, 100 and 150 mg capsules on October 20, 1997. Venlafaxine (Effexor, (R/S)-1-[2-(dimethylamino)-1-(4 methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[a [a- (dimethylamino)methyl] p-methoxybenzyl] cyclohexanol hydrochloride) is an antidepressant of the serotonin-norepinephrine reuptake inhibitor (SNRI) class first introduced by Wyeth in 1993. Venlafaxine was the sixth most widely-used antidepressant based on the number of retail prescriptions in the US (17.1 million) in 2006. Venlafaxine is used primarily for the treatment of depression, generalized anxiety disorder, social anxiety disorder, and panic disorder in adults
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.

Other generic players in litigation : Anchen Pharmaceuticals, Lupin, Sandoz, Mylan, Wockhardt, Biovail