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Last Updated: January 27, 2023

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, Anchen Pharms, Annora Pharma, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Intellipharmaceutics, Inventia Hlthcare, Macleods Pharms Ltd, Mylan, Orbion Pharms, Teva, Torrent, Valeant Pharms North, Wockhardt Bio Ag, Yichang Humanwell, Zydus Pharms Usa Inc, Alkem Labs Ltd, Appco, Ascent Pharms Inc, Cadila Pharms Ltd, Dexcel, Jb Chems Pharms, 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-three NDAs. Additional information is available in the individual branded drug profile pages.

There are forty-one drug master file entries for venlafaxine hydrochloride. Sixty-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
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
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
Mylan VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 078789-002 Jun 1, 2011 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sun Pharm Inds Inc VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET;ORAL 078627-001 Jun 13, 2008 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ascent Pharms Inc VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET, EXTENDED RELEASE;ORAL 214419-003 Oct 21, 2020 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
Wyeth Pharms Inc EFFEXOR venlafaxine hydrochloride TABLET;ORAL 020151-002 Dec 28, 1993 See Plans and Pricing See Plans and Pricing
Osmotica Pharm VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022104-004 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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Johnson and Johnson
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Merck
Moodys
Boehringer Ingelheim

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