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Last Updated: July 5, 2020

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Olmesartan medoxomil - Generic Drug Details

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What are the generic sources for olmesartan medoxomil and what is the scope of patent protection?

Olmesartan medoxomil is the generic ingredient in two branded drugs marketed by Daiichi Sankyo, Accord Hlthcare, Alembic Pharms Ltd, Alkem Labs Ltd, Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, Micro Labs, Mylan, Qilu, Sandoz Inc, Sciegen Pharms Inc, Sunshine Lake, Teva Pharms Usa, Torrent, Umedica Labs Pvt Ltd, and Zydus Pharms, and is included in nineteen NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-six drug master file entries for olmesartan medoxomil. Twenty-three suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for olmesartan medoxomil

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Recent Clinical Trials for olmesartan medoxomil

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SponsorPhase
Pharmtechnology LLCPhase 1
Altasciences Company Inc.Phase 1
Daiichi Sankyo Co., Ltd.Phase 3

See all olmesartan medoxomil clinical trials

Generic filers with tentative approvals for OLMESARTAN MEDOXOMIL
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial40MGTABLET;ORAL
  Start Trial  Start Trial20MGTABLET;ORAL
  Start Trial  Start Trial5MGTABLET;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 olmesartan medoxomil
Medical Subject Heading (MeSH) Categories for olmesartan medoxomil
Paragraph IV (Patent) Challenges for OLMESARTAN MEDOXOMIL
Tradename Dosage Ingredient NDA Submissiondate
BENICAR TABLET;ORAL olmesartan medoxomil 021286 2006-04-25

US Patents and Regulatory Information for olmesartan medoxomil

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma Ltd OLMESARTAN MEDOXOMIL olmesartan medoxomil TABLET;ORAL 204798-002 Apr 24, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Sandoz Inc OLMESARTAN MEDOXOMIL olmesartan medoxomil TABLET;ORAL 090237-001 Apr 13, 2020 AB RX No No   Start Trial   Start Trial   Start Trial
Lupin Ltd OLMESARTAN MEDOXOMIL olmesartan medoxomil TABLET;ORAL 206631-003 Apr 27, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Lupin Ltd OLMESARTAN MEDOXOMIL olmesartan medoxomil TABLET;ORAL 206631-001 Apr 27, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Micro Labs OLMESARTAN MEDOXOMIL olmesartan medoxomil TABLET;ORAL 206372-003 Sep 17, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Torrent OLMESARTAN MEDOXOMIL olmesartan medoxomil TABLET;ORAL 202375-003 Apr 24, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
>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 olmesartan medoxomil

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Daiichi Sankyo BENICAR olmesartan medoxomil TABLET;ORAL 021286-001 Apr 25, 2002   Start Trial   Start Trial
Daiichi Sankyo BENICAR olmesartan medoxomil TABLET;ORAL 021286-004 Apr 25, 2002   Start Trial   Start Trial
Daiichi Sankyo BENICAR olmesartan medoxomil TABLET;ORAL 021286-003 Apr 25, 2002   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Medtronic
AstraZeneca
Harvard Business School
McKesson
Baxter
Johnson and Johnson

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