VENLAFAXINE HYDROCHLORIDE - Generic Drug Details
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, Adaptis, Alembic, Anchen Pharms, Annora Pharma, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Granules, Macleods Pharms, Nostrum Pharms Llc, Orbion Pharms, Pharmobedient, Platinum, Sciegen Pharms, Teva, Torrent, Valeant Pharms North, Yichang Humanwell, Zydus Pharms Usa Inc, Abon Pharms Llc, Ajanta Pharma Ltd, Alkem Labs Ltd, Ascent Pharms Inc, Cadila Pharms Ltd, Mpp Pharma, Osmotica Pharm Us, Pharmadax, Somerset Theraps Llc, Sun 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-nine NDAs. Additional information is available in the individual branded drug profile pages.Sixty-two suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for VENLAFAXINE HYDROCHLORIDE
| US Patents: | 0 |
| Tradenames: | 3 |
| Applicants: | 44 |
| NDAs: | 49 |
| Finished Product Suppliers / Packagers: | 63 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 218 |
| Patent Applications: | 3,709 |
| 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 |
|---|---|
| Tongji Hospital | NA |
| Anhui Medical University | PHASE2 |
| Lakshmi N Yatham | PHASE3 |
Generic filers with tentative approvals for VENLAFAXINE HYDROCHLORIDE
| Applicant | Application No. | Strength | Dosage Form |
| ⤷ Start Trial | ⤷ Start Trial | 150MG | CAPSULE, EXTENDED RELEASE; ORAL |
| ⤷ Start Trial | ⤷ Start Trial | 75MG | CAPSULE, EXTENDED RELEASE; ORAL |
| ⤷ Start Trial | ⤷ Start Trial | 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
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Yichang Humanwell | VENLAFAXINE HYDROCHLORIDE | venlafaxine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 214654-001 | Aug 6, 2021 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Torrent | VENLAFAXINE HYDROCHLORIDE | venlafaxine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 218180-001 | Jan 28, 2025 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Macleods Pharms | VENLAFAXINE HYDROCHLORIDE | venlafaxine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 204889-001 | Oct 5, 2017 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Aurobindo Pharma Ltd | VENLAFAXINE HYDROCHLORIDE | venlafaxine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 200834-003 | Apr 14, 2011 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Sun Pharm | VENLAFAXINE HYDROCHLORIDE | venlafaxine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 091272-001 | Aug 18, 2010 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >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 Us | VENLAFAXINE HYDROCHLORIDE | venlafaxine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022104-004 | May 20, 2008 | ⤷ Start Trial | ⤷ Start Trial |
| Wyeth Pharms Inc | EFFEXOR | venlafaxine hydrochloride | TABLET;ORAL | 020151-004 | Dec 28, 1993 | ⤷ Start Trial | ⤷ Start Trial |
| Wyeth Pharms Inc | EFFEXOR | venlafaxine hydrochloride | TABLET;ORAL | 020151-003 | Dec 28, 1993 | ⤷ Start Trial | ⤷ Start Trial |
| Osmotica Pharm Us | VENLAFAXINE HYDROCHLORIDE | venlafaxine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022104-001 | May 20, 2008 | ⤷ Start Trial | ⤷ Start Trial |
| Osmotica Pharm Us | VENLAFAXINE HYDROCHLORIDE | venlafaxine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022104-003 | May 20, 2008 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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