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Last Updated: October 12, 2024

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, Alembic, Anchen Pharms, Annora Pharma, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Granules, Intellipharmaceutics, Inventia Hlthcare, Macleods Pharms Ltd, Norvium Bioscience, Nostrum Pharms Llc, Orbion Pharms, Teva, Torrent, Valeant Pharms North, Wockhardt Bio Ag, Yichang Humanwell, Zydus Pharms Usa Inc, Ajanta Pharma Ltd, Alkem Labs Ltd, Appco, Ascent Pharms Inc, Cadila Pharms Ltd, Dexcel, Nostrum Labs Inc, Osmotica Pharm Us, Sun Pharm, Swiss Pharm, Unique, Zydus Pharms, Wyeth Pharms Inc, Alembic Pharms Ltd, Amneal Pharms, Aurobindo Pharma, Chartwell Rx, Heritage Pharms, Mylan, Pliva Hrvatska Doo, Prinston Inc, Sun Pharm Inds Inc, Yaopharma Co Ltd, and Zydus Pharms Usa, and is included in forty-seven NDAs. Additional information is available in the individual branded drug profile pages.

There are forty-one drug master file entries for venlafaxine hydrochloride. Sixty-seven 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
Reinier de Graaf GroepPhase 3
Shalamar Institute of Health SciencesN/A
Dr. Inge WinterPhase 4

See all VENLAFAXINE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for VENLAFAXINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up75MGCAPSULE, EXTENDED RELEASE; ORAL
⤷  Sign Up⤷  Sign Up37.5MGCAPSULE, EXTENDED RELEASE; ORAL
⤷  Sign Up⤷  Sign Up150MGCAPSULE, 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
Anatomical Therapeutic Chemical (ATC) Classes for VENLAFAXINE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for VENLAFAXINE HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
VENLAFAXINE HYDROCHLORIDE Extended-release Tablets venlafaxine hydrochloride 225 mg 022104 1 2011-01-10
VENLAFAXINE HYDROCHLORIDE Extended-release Tablets venlafaxine hydrochloride 37.5 mg, 75 mg and 150 mg 022104 1 2009-02-12
EFFEXOR XR Extended-release Tablets venlafaxine hydrochloride 37.5 mg, 75 mg and 150 mg 020699 1 2007-05-03
EFFEXOR Tablets venlafaxine hydrochloride 25 mg, 37.5 mg, 50 mg, 75 mg and 100 mg 020151 1 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
Dr Reddys Labs Ltd VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 078421-003 May 6, 2011 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ajanta Pharma Ltd VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET, EXTENDED RELEASE;ORAL 214691-004 Apr 12, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Nostrum Pharms Llc VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 200430-001 Apr 4, 2023 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Upjohn EFFEXOR XR venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020699-003 Oct 20, 1997 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aurobindo Pharma Ltd VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 200834-001 Apr 14, 2011 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus Pharms Usa VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET;ORAL 077653-001 Jun 13, 2008 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Granules VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 217390-001 May 18, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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
Osmotica Pharm Us VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022104-003 May 20, 2008 ⤷  Sign Up ⤷  Sign Up
Upjohn EFFEXOR XR venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020699-002 Oct 20, 1997 ⤷  Sign Up ⤷  Sign Up
Upjohn EFFEXOR XR venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020699-004 Oct 20, 1997 ⤷  Sign Up ⤷  Sign Up
Wyeth Pharms Inc EFFEXOR venlafaxine hydrochloride TABLET;ORAL 020151-002 Dec 28, 1993 ⤷  Sign Up ⤷  Sign Up
Upjohn EFFEXOR XR venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020699-002 Oct 20, 1997 ⤷  Sign Up ⤷  Sign Up
Upjohn EFFEXOR XR venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020699-003 Oct 20, 1997 ⤷  Sign Up ⤷  Sign Up
Wyeth Pharms Inc EFFEXOR venlafaxine hydrochloride TABLET;ORAL 020151-004 Dec 28, 1993 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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