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Details for Generic Name: venlafaxine hydrochloride

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Venlafaxine hydrochloride is the generic ingredient in three branded drugs marketed by Wyeth Pharms Inc, Anchen Pharms, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Mylan, Orchid Hlthcare, Teva, Torrent Pharms Llc, Valeant Pharms North, Wockhardt, Zydus Pharms Usa Inc, Osmotica Pharm, Sun Pharma Global, Alembic Pharms Ltd, Amneal Pharms, Aurobindo Pharma, Heritage Pharms Inc, Pliva Hrvatska Doo, Sandoz, Sun Pharm Inds Inc, Vintage, Yaopharma Co Ltd, and Zydus Pharms Usa, and is included in twenty-seven NDAs. There are five patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has eigthy-six patent family members in forty-four countries.

There are sixty-four drug master file entries for venlafaxine hydrochloride. Nineteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: venlafaxine hydrochloride

Drug Master File Entries: see list64
Suppliers / Packaging: see list119
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details

Pharmacology for Ingredient: venlafaxine hydrochloride


Applicant Application No. Form Dosage
<disabled><disabled>CAPSULE, EXTENDED RELEASE; ORAL37.5MG
<disabled><disabled>CAPSULE, EXTENDED RELEASE; ORAL150MG

Clinical Trials for: venlafaxine hydrochloride

Venlafaxine Hydrochloride 150 mg Extended-Release Capsules Under Fed Conditions
Status: Completed Condition: Healthy

Venlafaxine Hydrochloride 150 mg Extended-Release Capsules Sprinkle Study
Status: Completed Condition: Healthy

Co-Administration of LDX (SPD489) and Venlafaxine XR (EFFEXOR XR) in Healthy Volunteers
Status: Completed Condition: Healthy

A Relative Bioavailability Study of 50 mg Venlafaxine Hydrochloride Tablets Under Fed Conditions
Status: Completed Condition: Healthy

Study to Examine the Effect of Gastric Bypass Surgery on Venlafaxine ER Blood Levels
Status: Completed Condition: Bariatric Surgery; Gastric Bypass; Roux-en-Y Gastric Bypass

Venlafaxine Hydrochloride 150 mg Extended-Release Capsules Under Fasting Conditions
Status: Completed Condition: Healthy

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
venlafaxine hydrochloride
TABLET;ORAL090027-002Aug 4, 2010RXNo<disabled><disabled>
Sun Pharm Inds Inc
venlafaxine hydrochloride
TABLET;ORAL078627-001Jun 13, 2008RXNo<disabled><disabled>
venlafaxine hydrochloride
TABLET;ORAL077515-002Jun 13, 2008DISCNNo<disabled><disabled>
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International Patent Family for Ingredient: venlafaxine hydrochloride

Country Document Number Publication Date
Denmark1028718Jul 28, 2003
Taiwan555568Oct 01, 2003
Poland195564Oct 31, 2007
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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