AMLODIPINE BESYLATE; VALSARTAN - Generic Drug Details
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What are the generic sources for amlodipine besylate; valsartan and what is the scope of patent protection?
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 |
|---|---|
| Alphacait, LLC | Phase 2 |
| Haining Health-Coming Biotech Co., Ltd. | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Torrent | AMLODIPINE BESYLATE AND VALSARTAN | amlodipine besylate; valsartan | TABLET;ORAL | 202377-001 | Mar 30, 2015 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Lupin | AMLODIPINE BESYLATE AND VALSARTAN | amlodipine besylate; valsartan | TABLET;ORAL | 090245-001 | Mar 30, 2015 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Novel Labs Inc | AMLODIPINE BESYLATE AND VALSARTAN | amlodipine besylate; valsartan | TABLET;ORAL | 202829-002 | Mar 30, 2015 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-005 | Jun 20, 2007 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hetero Labs | AMLODIPINE BESYLATE AND VALSARTAN | amlodipine besylate; valsartan | TABLET;ORAL | 205137-004 | Sep 16, 2016 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Lupin | AMLODIPINE BESYLATE AND VALSARTAN | amlodipine besylate; valsartan | TABLET;ORAL | 090245-002 | 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 | |||
| >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 | 021990-005 | 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 | 021990-004 | Jun 20, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-004 | Jun 20, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-003 | Jun 20, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-003 | Jun 20, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-003 | Jun 20, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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.
ISSN: 2162-2639
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