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, Alembic, Anchen Pharms, Annora Pharma, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Granules, Intellipharmaceutics, Inventia Hlthcare, Macleods Pharms Ltd, Norvium Bioscience, Nostrum Pharms Llc, Orbion Pharms, Teva, Torrent, Valeant Pharms North, Wockhardt Bio Ag, Yichang Humanwell, Zydus Pharms Usa Inc, Ajanta Pharma Ltd, Alkem Labs Ltd, Appco, Ascent Pharms Inc, Cadila Pharms Ltd, Dexcel, Nostrum Labs Inc, Osmotica Pharm Us, Sun Pharm, Swiss Pharm, Unique, Zydus Pharms, Wyeth Pharms Inc, Alembic Pharms Ltd, Amneal Pharms, Aurobindo Pharma, Chartwell Rx, Heritage, Pliva Hrvatska Doo, Prinston Inc, Sun Pharm Inds Inc, Yaopharma Co Ltd, and Zydus Pharms Usa, and is included in forty-seven NDAs. Additional information is available in the individual branded drug profile pages.

There are forty-one drug master file entries for venlafaxine hydrochloride. Sixty-six suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for VENLAFAXINE HYDROCHLORIDE

US Patents:	0
Tradenames:	3
Applicants:	42
NDAs:	47
Drug Master File Entries:	41
Finished Product Suppliers / Packagers:	66
Raw Ingredient (Bulk) Api Vendors:	129
Clinical Trials:	205
Patent Applications:	3,157
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VENLAFAXINE HYDROCHLORIDE
What excipients (inactive ingredients) are in VENLAFAXINE HYDROCHLORIDE?	VENLAFAXINE HYDROCHLORIDE excipients list
DailyMed Link:	VENLAFAXINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for VENLAFAXINE HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Reinier de Graaf Groep	Phase 3
Shalamar Institute of Health Sciences	N/A
Dr. Inge Winter	Phase 4

See all VENLAFAXINE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for VENLAFAXINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	150MG	CAPSULE, EXTENDED RELEASE; ORAL
⤷ Sign Up	⤷ Sign Up	75MG	CAPSULE, EXTENDED RELEASE; ORAL
⤷ Sign Up	⤷ Sign Up	37.5MG	CAPSULE, 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

Drug Class	Serotonin and Norepinephrine Reuptake Inhibitor
Mechanism of Action	Norepinephrine Uptake Inhibitors Serotonin Uptake Inhibitors

Medical Subject Heading (MeSH) Categories for VENLAFAXINE HYDROCHLORIDE

Antidepressive Agents, Second-Generation
Serotonin and Noradrenaline Reuptake Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for VENLAFAXINE HYDROCHLORIDE

N06AX	Other antidepressants
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

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

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Glossary

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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		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pliva Hrvatska Doo	VENLAFAXINE HYDROCHLORIDE	venlafaxine hydrochloride	TABLET;ORAL	078517-003	Jun 13, 2008		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Nostrum Pharms Llc	VENLAFAXINE HYDROCHLORIDE	venlafaxine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	200430-003	Apr 4, 2023		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ascent Pharms Inc	VENLAFAXINE HYDROCHLORIDE	venlafaxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	214419-002	Oct 21, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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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	⤷ Sign Up	⤷ Sign Up
Wyeth Pharms Inc	EFFEXOR	venlafaxine hydrochloride	TABLET;ORAL	020151-004	Dec 28, 1993	⤷ Sign Up	⤷ Sign Up
Upjohn	EFFEXOR XR	venlafaxine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020699-004	Oct 20, 1997	⤷ Sign Up	⤷ Sign Up
Upjohn	EFFEXOR XR	venlafaxine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020699-004	Oct 20, 1997	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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