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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 Dr Reddys Labs Ltd, Osmotica Pharm, Sandoz, Pliva Hrvatska Doo, Orchid Hlthcare, Sun Pharm Inds Inc, Vintage, Alembic Pharms Ltd, Aurobindo Pharma Ltd, Yaopharma Co Ltd, Wyeth Pharms Inc, Zydus Pharms Usa, Heritage Pharms Inc, Aurobindo Pharma, Teva, Wockhardt, Mylan, Valeant Pharms North, Sun Pharma Global, Zydus Pharms Usa Inc, Anchen Pharms, Amneal Pharms, and Torrent Pharms Llc, 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-seven patent family members in forty-four countries.

There are sixty-five 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 list65
Suppliers / Packaging: see list119
Therapeutic Class:Antidepressants

Pharmacology for Ingredient: venlafaxine hydrochloride

Tentative approvals for VENLAFAXINE HYDROCHLORIDE

Applicant Application No. Form Dosage
<disabled><disabled>CAPSULE, EXTENDED RELEASE; ORAL37.5MG
<disabled><disabled>CAPSULE, EXTENDED RELEASE; ORAL75MG
<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 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
Dr Reddys Labs Ltd
VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL078421-003May 6, 2011RXNo<disabled><disabled>
Wockhardt
VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL078865-003Apr 14, 2011RXNo<disabled><disabled>
Vintage
VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochloride
TABLET;ORAL090027-001Aug 4, 2010RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: venlafaxine hydrochloride

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Wyeth Pharms Inc
EFFEXOR XR
venlafaxine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020699-004Oct 20, 19974,535,186*PED<disabled>
Wyeth Pharms Inc
EFFEXOR XR
venlafaxine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020699-002Oct 20, 19976,444,708*PED<disabled>
Wyeth Pharms Inc
EFFEXOR
venlafaxine hydrochloride
TABLET;ORAL020151-001Dec 28, 19934,535,186*PED<disabled>
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International Patent Family for Ingredient: venlafaxine hydrochloride

Country Document Number Publication Date
Norway971206Sep 26, 1997
El Salvador1997000015Aug 13, 1997
Hong Kong1056686Dec 31, 2015
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2016 thinkBiotech LLC
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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