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Last Updated: November 2, 2024

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, 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-six 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 Up150MGCAPSULE, EXTENDED RELEASE; ORAL
⤷  Sign Up⤷  Sign Up75MGCAPSULE, EXTENDED RELEASE; ORAL
⤷  Sign Up⤷  Sign Up37.5MGCAPSULE, 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
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
Zydus Pharms Usa VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET;ORAL 077653-004 Jun 13, 2008 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Cadila Pharms Ltd VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET;ORAL 206250-004 Nov 21, 2018 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Dexcel VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209193-002 Oct 31, 2019 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 022104-004 May 20, 2008 ⤷  Sign Up ⤷  Sign Up
Upjohn EFFEXOR XR venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020699-001 Oct 20, 1997 ⤷  Sign Up ⤷  Sign Up
Osmotica Pharm Us VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022104-002 May 20, 2008 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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 data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. 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.