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Last Updated: October 21, 2020

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Venlafaxine hydrochloride - Generic Drug Details

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What are the generic drug sources for venlafaxine hydrochloride and what is the scope of freedom to operate?

Venlafaxine hydrochloride is the generic ingredient in three branded drugs marketed by Upjohn, Anchen Pharms, Annora Pharma, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Intellipharmaceutics, Inventia Hlthcare, Macleods Pharms Ltd, Mylan, Orchid Hlthcare, Teva, Torrent Pharms Llc, Valeant Pharms North, Wockhardt, Zydus Pharms Usa Inc, Cadila Pharms Ltd, Dexcel Pharma, Nostrum Labs Inc, Osmotica Pharm, Sun Pharm, Wyeth Pharms Inc, Alembic Pharms Ltd, Amneal Pharms, Aurobindo Pharma, Fosun Pharma, Heritage Pharms Inc, Pliva Hrvatska Doo, Prinston Inc, Sun Pharm Inds Inc, Yaopharma Co Ltd, and Zydus Pharms Usa, and is included in thirty-five NDAs. Additional information is available in the individual branded drug profile pages.

There are seventy-one drug master file entries for venlafaxine hydrochloride. Fifty-four suppliers are listed for this compound. There are two tentative approvals for this compound.

Recent Clinical Trials for venlafaxine hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Online PsychoTherapy ClinicN/A
Queen's UniversityN/A
American Hearing Research FoundationPhase 2/Phase 3

See all venlafaxine hydrochloride clinical trials

Generic filers with tentative approvals for VENLAFAXINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial150MGCAPSULE, EXTENDED RELEASE; ORAL
  Start Trial  Start Trial75MGCAPSULE, EXTENDED RELEASE; ORAL
  Start Trial  Start Trial37.5MGCAPSULE, EXTENDED RELEASE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for venlafaxine hydrochloride
Medical Subject Heading (MeSH) Categories for venlafaxine hydrochloride
Paragraph IV (Patent) Challenges for VENLAFAXINE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL venlafaxine hydrochloride 022104 2011-01-10
VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL venlafaxine hydrochloride 022104 2009-02-12
EFFEXOR XR CAPSULE, EXTENDED RELEASE;ORAL venlafaxine hydrochloride 020699 2007-05-03
EFFEXOR TABLET;ORAL venlafaxine hydrochloride 020151 2005-11-03

US Patents and Regulatory Information for venlafaxine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 076565-001 Jun 28, 2010 AB RX No No   Start Trial   Start Trial   Start Trial
Sun Pharm Inds Inc VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET;ORAL 078627-002 Jun 13, 2008 AB RX No No   Start Trial   Start Trial   Start Trial
Orchid Hlthcare VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 091123-001 Jul 11, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Dr Reddys Labs Ltd VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET;ORAL 078301-002 Jun 13, 2008 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET;ORAL 077166-005 Jun 13, 2008 AB RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 200834-001 Apr 14, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Cadila Pharms Ltd VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET, EXTENDED RELEASE;ORAL 211323-003 Aug 29, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for venlafaxine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Upjohn EFFEXOR XR venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020699-003 Oct 20, 1997   Start Trial   Start Trial
Osmotica Pharm VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022104-004 May 20, 2008   Start Trial   Start Trial
Osmotica Pharm VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022104-002 May 20, 2008   Start Trial   Start Trial
Wyeth Pharms Inc EFFEXOR venlafaxine hydrochloride TABLET;ORAL 020151-004 Dec 28, 1993   Start Trial   Start Trial
Upjohn EFFEXOR XR venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020699-003 Oct 20, 1997   Start Trial   Start Trial
Upjohn EFFEXOR XR venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020699-004 Oct 20, 1997   Start Trial   Start Trial
Upjohn EFFEXOR XR venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020699-001 Oct 20, 1997   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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Johnson and Johnson
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Merck
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Boehringer Ingelheim

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