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 freedom to operate?
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
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 10MG/40MG | TABLET; ORAL |
⤷ Sign Up | ⤷ Sign Up | 10MG/20MG | TABLET; ORAL |
⤷ Sign Up | ⤷ Sign Up | 5MG/40MG | 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 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Alembic | AMLODIPINE AND OLMESARTAN MEDOXOMIL | amlodipine besylate; olmesartan medoxomil | TABLET;ORAL | 207073-002 | Jul 17, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Teva Pharms Usa | AMLODIPINE AND OLMESARTAN MEDOXOMIL | amlodipine besylate; olmesartan medoxomil | TABLET;ORAL | 091154-003 | Oct 26, 2016 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Teva Pharms Usa | AMLODIPINE AND OLMESARTAN MEDOXOMIL | amlodipine besylate; olmesartan medoxomil | TABLET;ORAL | 091154-002 | Oct 26, 2016 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Cosette | AZOR | amlodipine besylate; olmesartan medoxomil | TABLET;ORAL | 022100-002 | Sep 26, 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; OLMESARTAN MEDOXOMIL
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
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 | 022100-004 | 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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