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Last Updated: September 21, 2020

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Venlafaxine hydrochloride - Generic Drug Details

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What are the generic sources for venlafaxine hydrochloride and what is the scope of patent protection?

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-five 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
Queen's UniversityN/A
Online PsychoTherapy ClinicN/A
Medical University of South CarolinaPhase 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
Dexcel Pharma VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209193-001 Oct 31, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 078789-001 Jun 1, 2011 DISCN No No   Start Trial   Start Trial   Start Trial
Anchen Pharms VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 078087-002 Mar 16, 2012 DISCN No No   Start Trial   Start Trial   Start Trial
Heritage Pharms Inc VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET;ORAL 078554-002 Jan 9, 2009 AB RX No No   Start Trial   Start Trial   Start Trial
Teva VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 076565-001 Jun 28, 2010 AB RX No No   Start Trial   Start Trial   Start Trial
Teva VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET;ORAL 076690-005 Aug 3, 2006 AB RX No No   Start Trial   Start Trial   Start Trial
Prinston Inc VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET;ORAL 090027-003 Aug 4, 2010 DISCN 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
Wyeth Pharms Inc EFFEXOR venlafaxine hydrochloride TABLET;ORAL 020151-006 Dec 28, 1993   Start Trial   Start Trial
Wyeth Pharms Inc EFFEXOR venlafaxine hydrochloride TABLET;ORAL 020151-006 Dec 28, 1993   Start Trial   Start Trial
Osmotica Pharm VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022104-003 May 20, 2008   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 020699-002 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
Upjohn EFFEXOR XR venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020699-004 Oct 20, 1997   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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