Venlafaxine hydrochloride - Generic Drug Details
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What are the generic sources for venlafaxine hydrochloride and what is the scope of patent protection?
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 Pharms, Mylan, 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: | 43 |
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 |
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
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Zydus Pharms Usa | VENLAFAXINE HYDROCHLORIDE | venlafaxine hydrochloride | TABLET;ORAL | 077653-004 | Jun 13, 2008 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Cadila Pharms Ltd | VENLAFAXINE HYDROCHLORIDE | venlafaxine hydrochloride | TABLET;ORAL | 206250-004 | Nov 21, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Dexcel | VENLAFAXINE HYDROCHLORIDE | venlafaxine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209193-002 | Oct 31, 2019 | 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 | 022104-004 | May 20, 2008 | ⤷ Sign Up | ⤷ Sign Up |
Upjohn | EFFEXOR XR | venlafaxine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020699-001 | Oct 20, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Osmotica Pharm Us | VENLAFAXINE HYDROCHLORIDE | venlafaxine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022104-002 | May 20, 2008 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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