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Venlafaxine hydrochloride - Generic Drug Details

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Venlafaxine hydrochloride is the generic ingredient in three branded drugs marketed by Dr Reddys Labs Ltd, Osmotica Pharm, Sandoz, Pliva Hrvatska Doo, Orchid Hlthcare, Sun Pharm Inds Inc, Vintage, Alembic Pharms Ltd, Aurobindo Pharma Ltd, Yaopharma Co Ltd, Wyeth Pharms Inc, Zydus Pharms Usa, Heritage Pharms Inc, Aurobindo Pharma, Teva, Wockhardt, Mylan, Valeant Pharms North, Sun Pharma Global, Zydus Pharms Usa Inc, Anchen Pharms, Amneal Pharms, and Torrent Pharms Llc, and is included in twenty-seven NDAs. There are five patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has eighty-seven patent family members in forty-four countries.

There are sixty-six drug master file entries for venlafaxine hydrochloride. Sixty-five suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: venlafaxine hydrochloride

Tradenames:3
Patents:5
Applicants:23
NDAs:27
Drug Master File Entries: see list66
Suppliers / Packaging: see list65
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details

Pharmacology for Ingredient: venlafaxine hydrochloride

Tentative approvals for VENLAFAXINE HYDROCHLORIDE

Applicant Application No. Form Dosage
<disabled><disabled>CAPSULE, EXTENDED RELEASE; ORAL37.5MG
<disabled><disabled>CAPSULE, EXTENDED RELEASE; ORAL75MG
<disabled><disabled>CAPSULE, EXTENDED RELEASE; ORAL150MG

Clinical Trials for: venlafaxine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Yaopharma Co Ltd
VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochloride
TABLET;ORAL202036-005May 28, 2015RXNo<disabled><disabled>
Zydus Pharms Usa Inc
VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL090174-001Apr 14, 2011RXNo<disabled><disabled>
Osmotica Pharm
VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochloride
TABLET, EXTENDED RELEASE;ORAL022104-002May 20, 2008RXNo6,403,120<disabled> <disabled>
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Expired Orange Book Patents for Generic Ingredient: venlafaxine hydrochloride

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Wyeth Pharms Inc
EFFEXOR
venlafaxine hydrochloride
TABLET;ORAL020151-002Dec 28, 19934,535,186*PED<disabled>
Wyeth Pharms Inc
EFFEXOR XR
venlafaxine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020699-003Oct 20, 19975,916,923*PED<disabled>
Wyeth Pharms Inc
EFFEXOR XR
venlafaxine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020699-002Oct 20, 19974,535,186*PED<disabled>
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International Patent Family for Ingredient: venlafaxine hydrochloride

Country Document Number Estimated Expiration
European Patent Office2881110<disabled in preview>
Argentina014012<disabled in preview>
Slovakia30197<disabled in preview>
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