VENLAFAXINE HYDROCHLORIDE Drug Patent Profile
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Which patents cover Venlafaxine Hydrochloride, and what generic alternatives are available?
Venlafaxine Hydrochloride is a drug marketed by 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, Alembic Pharms Ltd, Amneal Pharms, Aurobindo Pharma, Chartwell Rx, Heritage Pharms, Mylan, Pliva Hrvatska Doo, Prinston Inc, Sun Pharm Inds Inc, Yaopharma Co Ltd, and Zydus Pharms Usa. and is included in forty-five NDAs.
The generic ingredient in VENLAFAXINE HYDROCHLORIDE is venlafaxine hydrochloride. There are seventy-one drug master file entries for this compound. Sixty-six suppliers are listed for this compound. Additional details are available on the venlafaxine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Venlafaxine Hydrochloride
A generic version of VENLAFAXINE HYDROCHLORIDE was approved as venlafaxine hydrochloride by TEVA on August 3rd, 2006.
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Summary for VENLAFAXINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 41 |
| NDAs: | 45 |
| Finished Product Suppliers / Packagers: | 63 |
| Raw Ingredient (Bulk) Api Vendors: | 129 |
| Clinical Trials: | 205 |
| Patent Applications: | 2,087 |
| 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 |
| Westfälische Wilhelms-Universität Münster | Phase 4 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dexcel | VENLAFAXINE HYDROCHLORIDE | venlafaxine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 213927-001 | Jan 21, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Amneal Pharms | VENLAFAXINE HYDROCHLORIDE | venlafaxine hydrochloride | TABLET;ORAL | 079098-002 | May 11, 2010 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Torrent | VENLAFAXINE HYDROCHLORIDE | venlafaxine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 090899-002 | Jun 1, 2011 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Nostrum Pharms Llc | VENLAFAXINE HYDROCHLORIDE | venlafaxine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 200430-002 | Apr 4, 2023 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Yaopharma Co Ltd | VENLAFAXINE HYDROCHLORIDE | venlafaxine hydrochloride | TABLET;ORAL | 202036-004 | May 28, 2015 | 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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Osmotica Pharm Us | VENLAFAXINE HYDROCHLORIDE | venlafaxine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022104-002 | May 20, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| Osmotica Pharm Us | VENLAFAXINE HYDROCHLORIDE | venlafaxine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022104-001 | May 20, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| Osmotica Pharm Us | VENLAFAXINE HYDROCHLORIDE | venlafaxine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022104-004 | May 20, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| Osmotica Pharm Us | VENLAFAXINE HYDROCHLORIDE | venlafaxine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022104-002 | May 20, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| Osmotica Pharm Us | VENLAFAXINE HYDROCHLORIDE | venlafaxine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022104-003 | May 20, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for VENLAFAXINE HYDROCHLORIDE
See the table below for patents covering VENLAFAXINE HYDROCHLORIDE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| El Salvador | 1998000131 | FORMULACIONES DE ACCION PROLONGADA REF. AHP-95011-1-C1 | ⤷ Sign Up |
| India | 187337 | A process for preparing an encapsulated extended release formulation of venlafaxine hydrochloride | ⤷ Sign Up |
| Norway | 971206 | ⤷ Sign Up | |
| Japan | H107552 | SUSTAINED RELEASE PHARMACEUTICAL PREPARATION | ⤷ Sign Up |
| China | 1278165 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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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 verification 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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