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Last Updated: November 21, 2024

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
Recent Clinical Trials for AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
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 Up10MG/40MGTABLET; ORAL
⤷  Sign Up⤷  Sign Up10MG/20MGTABLET; ORAL
⤷  Sign Up⤷  Sign Up5MG/40MGTABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Paragraph IV (Patent) Challenges 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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