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Generated: October 23, 2017

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Venlafaxine hydrochloride - Generic Drug Details

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What are the generic drug sources for venlafaxine hydrochloride and what is the scope of venlafaxine hydrochloride freedom to operate?

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

Venlafaxine hydrochloride has ninety-two patent family members in forty-four countries.

There are seventy-one drug master file entries for venlafaxine hydrochloride. Seventy-four suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: venlafaxine hydrochloride

US Patents:5
Tradenames:3
Applicants:25
NDAs:29
Drug Master File Entries: see list71
Suppliers / Packagers: see list74
Bulk Api Vendors: see list61
Clinical Trials: see list2,426
Patent Applications: see list2,464
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:venlafaxine hydrochloride at DailyMed

Pharmacology for Ingredient: venlafaxine hydrochloride

Tentative approvals for VENLAFAXINE HYDROCHLORIDE

Applicant Application No. Strength Dosage Form
u► Subscribe37.5MGCAPSULE, EXTENDED RELEASE; ORAL
u► Subscribe150MGCAPSULE, EXTENDED RELEASE; ORAL
u► Subscribe75MGCAPSULE, EXTENDED RELEASE; ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Orchid Hlthcare
VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL091123-002Jul 11, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe
Sandoz
VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochloride
TABLET;ORAL077515-001Jun 13, 2008DISCNNoNo► Subscribe► Subscribe► Subscribe
Mylan
VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochloride
TABLET;ORAL077166-002Jun 13, 2008ABRXNoNo► Subscribe► Subscribe► Subscribe
Sandoz
VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochloride
TABLET;ORAL077515-004Jun 13, 2008DISCNNoNo► Subscribe► Subscribe► Subscribe
Teva
VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochloride
TABLET;ORAL076690-005Aug 3, 2006ABRXNoNo► Subscribe► Subscribe► Subscribe
Aurobindo Pharma
VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochloride
TABLET;ORAL090555-005Apr 7, 2010ABRXNoNo► Subscribe► Subscribe► Subscribe
Dr Reddys Labs Ltd
VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochloride
TABLET;ORAL078301-003Jun 13, 2008ABRXNoNo► Subscribe► Subscribe► Subscribe
Amneal Pharms
VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochloride
TABLET;ORAL079098-002May 11, 2010ABRXNoNo► Subscribe► Subscribe► Subscribe
Zydus Pharms Usa
VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochloride
TABLET;ORAL077653-003Jun 13, 2008ABRXNoNo► Subscribe► Subscribe► Subscribe
Heritage Pharms Inc
VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochloride
TABLET;ORAL078554-003Jan 9, 2009ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: venlafaxine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Wyeth Pharms Inc
EFFEXOR XR
venlafaxine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020699-004Oct 20, 1997► Subscribe► Subscribe
Wyeth Pharms Inc
EFFEXOR
venlafaxine hydrochloride
TABLET;ORAL020151-001Dec 28, 1993► Subscribe► Subscribe
Wyeth Pharms Inc
EFFEXOR
venlafaxine hydrochloride
TABLET;ORAL020151-005Dec 28, 1993► Subscribe► Subscribe
Wyeth Pharms Inc
EFFEXOR XR
venlafaxine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020699-004Oct 20, 1997► Subscribe► Subscribe
Wyeth Pharms Inc
EFFEXOR XR
venlafaxine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020699-002Oct 20, 1997► Subscribe► Subscribe
Osmotica Pharm
VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochloride
TABLET, EXTENDED RELEASE;ORAL022104-003May 20, 2008► Subscribe► Subscribe
Wyeth Pharms Inc
EFFEXOR XR
venlafaxine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020699-004Oct 20, 1997► Subscribe► Subscribe
Wyeth Pharms Inc
EFFEXOR XR
venlafaxine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL020699-002Oct 20, 1997► Subscribe► Subscribe
Osmotica Pharm
VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochloride
TABLET, EXTENDED RELEASE;ORAL022104-004May 20, 2008► Subscribe► Subscribe
Osmotica Pharm
VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochloride
TABLET, EXTENDED RELEASE;ORAL022104-001May 20, 2008► Subscribe► Subscribe
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International Patent Family for Ingredient: venlafaxine hydrochloride

Country Document Number Estimated Expiration
Cyprus2442► Subscribe
Slovenia1028718► Subscribe
Czech Republic9700772► Subscribe
Australia727653► Subscribe
Peru57198► Subscribe
Austria237320► Subscribe
Mexico9701873► Subscribe
Norway971206► Subscribe
Slovakia281530► Subscribe
Norway20002126► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Serving leading biopharmaceutical companies globally:

Accenture
Teva
Colorcon
Johnson and Johnson
QuintilesIMS
Fish and Richardson
Cantor Fitzgerald
Federal Trade Commission
Queensland Health
Boehringer Ingelheim

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 verifification 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.

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