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Last Updated: September 16, 2021

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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, Atlantide, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Intellipharmaceutics, Inventia Hlthcare, Macleods Pharms Ltd, Mylan, Orchid Hlthcare, Teva, Torrent Pharms Llc, Valeant Pharms North, Yichang Humanwell, Zydus Pharms Usa Inc, Alkem Labs Ltd, Appco, Ascent Pharms 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 forty NDAs. Additional information is available in the individual branded drug profile pages.

There are seventy-one drug master file entries for venlafaxine hydrochloride. Fifty-nine 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
Milwaukee VA Medical CenterPhase 4
San Diego Veterans Healthcare SystemPhase 4
Coatesville VA Medical CenterPhase 4

See all venlafaxine hydrochloride clinical trials

Generic filers with tentative approvals for VENLAFAXINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Free Forever Trial⤷  Free Forever Trial150MGCAPSULE, EXTENDED RELEASE; ORAL
⤷  Free Forever Trial⤷  Free Forever Trial75MGCAPSULE, EXTENDED RELEASE; ORAL
⤷  Free Forever Trial⤷  Free Forever 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
Anatomical Therapeutic Chemical (ATC) Classes 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
Intellipharmaceutics VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 201272-001 Nov 23, 2018 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Amneal Pharms VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET;ORAL 079098-004 May 11, 2010 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Alembic Pharms Ltd VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET;ORAL 078932-004 Dec 14, 2010 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Orchid Hlthcare VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 091123-003 Jul 11, 2011 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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 020699-002 Oct 20, 1997 ⤷  Free Forever Trial ⤷  Free Forever Trial
Upjohn EFFEXOR XR venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020699-003 Oct 20, 1997 ⤷  Free Forever Trial ⤷  Free Forever Trial
Wyeth Pharms Inc EFFEXOR venlafaxine hydrochloride TABLET;ORAL 020151-002 Dec 28, 1993 ⤷  Free Forever Trial ⤷  Free Forever Trial
Wyeth Pharms Inc EFFEXOR venlafaxine hydrochloride TABLET;ORAL 020151-001 Dec 28, 1993 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Express Scripts
AstraZeneca
Merck
Dow
Medtronic
Mallinckrodt

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