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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

Tradenames:3
Patents:5
Applicants:23
NDAs:27
Drug Master File Entries: see list64
Suppliers / Packaging: see list119
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details

Pharmacology for Ingredient: venlafaxine hydrochloride

Tentative approvals for VENLAFAXINE HYDROCHLORIDE

Applicant Application No. Form Dosage
<disabled><disabled>CAPSULE, EXTENDED RELEASE; ORAL75MG
<disabled><disabled>CAPSULE, EXTENDED RELEASE; ORAL150MG
<disabled><disabled>CAPSULE, EXTENDED RELEASE; ORAL37.5MG

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

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

Study to Examine the Effect of Gastric Bypass Surgery on Venlafaxine ER Blood Levels
Status: Active, not recruiting Condition: Bariatric Surgery; Gastric Bypass; Roux-en-Y Gastric Bypass

Courtesy of ClinicalTrials.org
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
Amneal Pharms
VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochloride
TABLET;ORAL079098-001May 11, 2010RXNo<disabled><disabled>
Wyeth Pharms Inc
EFFEXOR XR
venlafaxine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020699-002Oct 20, 1997RXNo6,419,958*PED<disabled>Y<disabled>
Alembic Pharms Ltd
VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochloride
TABLET;ORAL078932-003Dec 14, 2010RXNo<disabled><disabled>
Vintage
VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochloride
TABLET;ORAL090027-004Aug 4, 2010RXNo<disabled><disabled>
Osmotica Pharm
VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochloride
TABLET, EXTENDED RELEASE;ORAL022104-001May 20, 2008RXNo6,403,120<disabled><disabled>
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International Patent Family for Ingredient: venlafaxine hydrochloride

Country Document Number Publication Date
Egypt24198Oct 14, 2008
Canada2199778Dec 20, 2005
Norway971206Sep 26, 1997
Poland341141Mar 26, 2001
Norway971206Mar 14, 1997
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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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