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Last Updated: December 7, 2022

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, Orbion Pharms, Teva, Torrent, 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, Sunny, Zydus Pharms, Wyeth Pharms Inc, Alembic Pharms Ltd, Amneal Pharms, Aurobindo Pharma, Fosun Pharma, Heritage Pharms, Pliva Hrvatska Doo, Prinston Inc, Sun Pharm Inds Inc, Yaopharma Co Ltd, and Zydus Pharms Usa, and is included in forty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are forty-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
Dr. Inge WinterPhase 4
Westfälische Wilhelms-Universität MünsterPhase 4
Nanfang Hospital of Southern Medical UniversityPhase 2

See all venlafaxine hydrochloride clinical trials

Generic filers with tentative approvals for VENLAFAXINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing150MGCAPSULE, EXTENDED RELEASE; ORAL
See Plans and PricingSee Plans and Pricing75MGCAPSULE, EXTENDED RELEASE; ORAL
See Plans and PricingSee Plans and Pricing37.5MGCAPSULE, 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.

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
Amneal Pharms VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET;ORAL 079098-002 May 11, 2010 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Zydus Pharms VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET, EXTENDED RELEASE;ORAL 215622-001 Aug 30, 2022 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sun Pharm Inds Inc VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET;ORAL 078627-003 Jun 13, 2008 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Alkem Labs Ltd VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET, EXTENDED RELEASE;ORAL 214127-003 Jun 10, 2021 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022104-001 May 20, 2008 See Plans and Pricing See Plans and Pricing
Upjohn EFFEXOR XR venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020699-004 Oct 20, 1997 See Plans and Pricing See Plans and Pricing
Wyeth Pharms Inc EFFEXOR venlafaxine hydrochloride TABLET;ORAL 020151-002 Dec 28, 1993 See Plans and Pricing See Plans and Pricing
Upjohn EFFEXOR XR venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020699-004 Oct 20, 1997 See Plans and Pricing See Plans and Pricing
>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.