The plaintiffs in the Effexor XR
case have challenged a patent settlement agreement between drug manufacturers Wyeth and Teva Pharmaceuticals, alleging that Teva agreed to delay introduction of its generic version of Wyeth's blockbuster antidepressant drug Effexor XR
until July 1, 2010, and that Wyeth agreed not to market an authorized generic version of Effexor XR
for a period of time.
3 June 2011 - US Mylan Inc (NASDAQ: MYL) said yesterday that its subsidiary Mylan Pharmaceuticals has obtained final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Venlafaxine Hydrochloride (HCl) Extended-release (ER) Capsules, 37.5 mg (base), 75 mg (base) and 150 mg (base), the generic version of Wyeth's Effexor XR
Wyeth-Ayerst Antidepressant (serotonin/ norepinephrine reuptake inhibitor) 14.
Following Teva's submission of an ANDA (Abbreviated New Drug Application) for generic extended release venlafaxine capsules (equivalent of Wyeth's Effexor XR
), Wyeth claimed for infringement of three of their patents.
Prescriptions for venlafaxine "should be written for the smallest quantity of capsules consistent with good patient management, in order to reduce the risk of overdose," according to the revised label or prescribing information for Effexor and Effexor XR
The second-line drugs were sertraline (Zoloft), another SSRI, taken by 238 subjects; sustained-release bupropion, one of a different class of antidepressants that are not SSRIs, taken by 239 subjects; and extended-release venlafaxine (Effexor XR
), a dual-action agent that inhibits reuptake of both serotonin and norepinephrine, taken by 250 subjects.
The relative risks of nine newer antidepressants in the trials--citalopram (Celexa), fluvoxamine (Luvox), paroxetine (Paxil), fluoxetine (Prozac), sertraline (Zoloft), venlafaxine (Effexor XR
), mirtazapine (Remeron), nefazodone (Serzone), and bupropion (Wellbutrin)--varied, and most of the risks came from but were not limited to trials of major depressive disorder (MDD).
The trial included 30 patients with current major depressive disorder (MDD) despite an adequate dose of a single Selective Serotonin Reuptake Inhibitor (SSRI), the most common class of antidepressants or venlafaxine (Effexor XR
RANK COST DRUG NAME 2003 2002 INCREASE * Oxycontin 1 1 15% Neurontin 2 3 12% Celebrex 3 2 12% Hydroco/Apap 4 5 12% Vioxx 5 4 6% Duragesic 6 6 14% Bextra 7 11 33% Carisoprodol 8 7 8% Ambien 9 9 14% Skelaxin 10 13 29% Lidoderm 11 22 12% Tizanidine 12 37 60% Cyclobenzapr 13 12 11% Tramadol Hcl 14 35 30% Actiq 15 32 55% Ultracet 16 19 23% Percocet 17 21 30% Ranitidine 18 27 26% Propo-N/Apap 19 14 -3% Effexor Xr
20 17 13% Naproxen 21 16 17% Topamax 22 24 22% Morphine Sul 23 29 -1% Zoloft 24 18 6% Wellbutrin 25 31 3% Sub-Total Top 25 12% * Change in the average prescription cost in the calendar year for claimants receiving the drug.
Lipitor, a cholesterol-lowering drug with an average cost of $75; Zoloft, an antidepressant with an average cost of $55; Protonix, a drug used for gastritis/ esophagitis with an average cost of $85; Paxil, an antidepressant with an average cost of $73; and Effexor XR
, an antidepressant with an average cost of $84.
Wyeth-Ayerst Laboratories, the pharmaceutical division of American Home Products Corporation (NYSE: AHP), has launched EffexorXR.com, the first phase of an extensive Internet Web site designed to provide consumers and health care professionals with comprehensive information about depression and generalized anxiety disorder (GAD) and EFFEXOR XR
(venlafaxine HCl) Extended-Release Capsules.
(venlafaxine HCl) Extended-Release Capsules, the only antidepressant indicated to treat generalized anxiety disorder (GAD), is also the first and only medication to demonstrate long-term efficacy and safety in this condition, according to new data published in the Journal of the American Medical Association.