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Valsartan - Generic Drug Details
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What are the generic drug sources for valsartan and what is the scope of freedom to operate?
Valsartan
is the generic ingredient in three branded drugs marketed by Novartis, Carmel Biosciences, Alembic Pharms Ltd, Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Hetero Labs Ltd V, Ivax Pharms, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, Mylan, Ohm Labs Inc, Prinston Inc, Square Pharms Ltd, Torrent, Unichem, and Watson Labs Inc, and is included in nineteen NDAs. Additional information is available in the individual branded drug profile pages.There are forty drug master file entries for valsartan. Twenty-five suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for valsartan
US Patents: | 0 |
Tradenames: | 3 |
Applicants: | 18 |
NDAs: | 19 |
Drug Master File Entries: | 40 |
Suppliers / Packagers: | 25 |
Bulk Api Vendors: | 132 |
Clinical Trials: | 331 |
Patent Applications: | 6,981 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for valsartan |
Drug Sales Revenues: | Drug sales revenues for valsartan |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for valsartan |
What excipients (inactive ingredients) are in valsartan? | valsartan excipients list |
DailyMed Link: | valsartan at DailyMed |
Recent Clinical Trials for valsartan
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Yale University | Phase 4 |
Amir Safwat | Phase 4 |
Hospital Universitário Professor Edgard Santos | Phase 2 |
Generic filers with tentative approvals for VALSARTAN
Applicant | Application No. | Strength | Dosage Form |
Start Trial | Start Trial | 160MG; 12.5MG | TABLET; ORAL |
Start Trial | Start Trial | 80MG; 12.5MG | TABLET; ORAL |
Start Trial | Start Trial | 320MG; 25MG | TABLET; 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 valsartan
Drug Class | Angiotensin 2 Receptor Blocker |
Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for valsartan
US Patents and Regulatory Information for valsartan
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis | DIOVAN | valsartan | TABLET;ORAL | 021283-001 | Jul 18, 2001 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
Prinston Inc | VALSARTAN | valsartan | TABLET;ORAL | 204821-002 | Jun 9, 2015 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Lupin Ltd | VALSARTAN | valsartan | TABLET;ORAL | 201677-001 | Jan 5, 2015 | AB | RX | 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 valsartan
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | DIOVAN | valsartan | TABLET;ORAL | 021283-001 | Jul 18, 2001 | Start Trial | Start Trial |
Novartis | DIOVAN | valsartan | CAPSULE;ORAL | 020665-001 | Dec 23, 1996 | Start Trial | Start Trial |
Novartis | DIOVAN | valsartan | TABLET;ORAL | 021283-004 | Aug 14, 2002 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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