Amlodipine besylate; valsartan - Generic Drug Details
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What are the generic drug sources for amlodipine besylate; valsartan and what is the scope of freedom to operate?
Amlodipine besylate; valsartan
is the generic ingredient in two branded drugs marketed by Alembic, Aurobindo Pharma, Hetero Labs, Lupin, Mylan, Novel Labs Inc, Strides Pharma, Teva Pharms Usa, Torrent, and Novartis, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.Nine suppliers are listed for this compound.
Summary for amlodipine besylate; valsartan
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 10 |
NDAs: | 10 |
Finished Product Suppliers / Packagers: | 9 |
Clinical Trials: | 3 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for amlodipine besylate; valsartan |
DailyMed Link: | amlodipine besylate; valsartan at DailyMed |
Recent Clinical Trials for amlodipine besylate; valsartan
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Haining Health-Coming Biotech Co., Ltd. | Phase 2 |
Alphacait, LLC | Phase 2 |
CJ HealthCare Corporation | Phase 1 |
Pharmacology for amlodipine besylate; valsartan
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
EXFORGE | Tablets | amlodipine besylate; valsartan | 5 mg/320 mg | 021990 | 1 | 2007-11-26 |
EXFORGE | Tablets | amlodipine besylate; valsartan | 10 mg/320 mg | 021990 | 1 | 2007-11-09 |
EXFORGE | Tablets | amlodipine besylate; valsartan | 5 mg/160 mg | 021990 | 1 | 2007-10-22 |
EXFORGE | Tablets | amlodipine besylate; valsartan | 10 mg/160 mg | 021990 | 1 | 2007-10-01 |
US Patents and Regulatory Information for amlodipine besylate; valsartan
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Lupin | AMLODIPINE BESYLATE AND VALSARTAN | amlodipine besylate; valsartan | TABLET;ORAL | 090245-003 | Mar 30, 2015 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Lupin | AMLODIPINE BESYLATE AND VALSARTAN | amlodipine besylate; valsartan | TABLET;ORAL | 090245-004 | Mar 30, 2015 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Torrent | AMLODIPINE BESYLATE AND VALSARTAN | amlodipine besylate; valsartan | TABLET;ORAL | 202377-001 | Mar 30, 2015 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-002 | Jun 20, 2007 | AB | RX | Yes | 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 amlodipine besylate; valsartan
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-004 | Jun 20, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-005 | Jun 20, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-002 | Jun 20, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-005 | Jun 20, 2007 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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