Amlodipine besylate; olmesartan medoxomil - Generic Drug Details
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What are the generic sources for amlodipine besylate; olmesartan medoxomil and what is the scope of patent protection?
Amlodipine besylate; olmesartan medoxomil
is the generic ingredient in two branded drugs marketed by Accord Hlthcare Inc, Ajanta Pharma Ltd, Alembic, Alkem Labs Ltd, Aurobindo Pharma, Glenmark Pharms Ltd, Jubilant Generics, Macleods Pharms Ltd, Micro Labs, Sciegen Pharms Inc, Teva Pharms Usa, Torrent, Zydus Pharms, and Cosette, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.Eighteen suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for amlodipine besylate; olmesartan medoxomil
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 14 |
| NDAs: | 14 |
| Finished Product Suppliers / Packagers: | 18 |
| Clinical Trials: | 4 |
| DailyMed Link: | amlodipine besylate; olmesartan medoxomil at DailyMed |
Recent Clinical Trials for amlodipine besylate; olmesartan medoxomil
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Daiichi Sankyo, Inc. | Phase 3 |
| Daiichi Sankyo Inc. | Phase 3 |
| Daiichi Sankyo, Inc. | Phase 4 |
See all amlodipine besylate; olmesartan medoxomil clinical trials
Generic filers with tentative approvals for AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
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 amlodipine besylate; olmesartan medoxomil
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| AZOR | Tablets | amlodipine besylate; olmesartan medoxomil | 10 mg/20 mg and 5 mg/40 mg | 022100 | 1 | 2008-03-31 |
| AZOR | Tablets | amlodipine besylate; olmesartan medoxomil | 5 mg/20 mg and 10 mg/40 mg | 022100 | 1 | 2008-02-11 |
US Patents and Regulatory Information for amlodipine besylate; olmesartan medoxomil
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alkem Labs Ltd | AMLODIPINE AND OLMESARTAN MEDOXOMIL | amlodipine besylate; olmesartan medoxomil | TABLET;ORAL | 209042-002 | Aug 14, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Alkem Labs Ltd | AMLODIPINE AND OLMESARTAN MEDOXOMIL | amlodipine besylate; olmesartan medoxomil | TABLET;ORAL | 209042-004 | Aug 14, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Micro Labs | AMLODIPINE AND OLMESARTAN MEDOXOMIL | amlodipine besylate; olmesartan medoxomil | TABLET;ORAL | 207435-001 | Nov 2, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sciegen Pharms Inc | AMLODIPINE AND OLMESARTAN MEDOXOMIL | amlodipine besylate; olmesartan medoxomil | TABLET;ORAL | 209010-001 | Dec 3, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Glenmark Pharms Ltd | AMLODIPINE AND OLMESARTAN MEDOXOMIL | amlodipine besylate; olmesartan medoxomil | TABLET;ORAL | 207807-003 | Jul 5, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sciegen Pharms Inc | AMLODIPINE AND OLMESARTAN MEDOXOMIL | amlodipine besylate; olmesartan medoxomil | TABLET;ORAL | 209010-004 | Dec 3, 2018 | 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; olmesartan medoxomil
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Cosette | AZOR | amlodipine besylate; olmesartan medoxomil | TABLET;ORAL | 022100-004 | Sep 26, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| Cosette | AZOR | amlodipine besylate; olmesartan medoxomil | TABLET;ORAL | 022100-001 | Sep 26, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| Cosette | AZOR | amlodipine besylate; olmesartan medoxomil | TABLET;ORAL | 022100-003 | Sep 26, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| Cosette | AZOR | amlodipine besylate; olmesartan medoxomil | TABLET;ORAL | 022100-002 | Sep 26, 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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