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Last Updated: February 17, 2020

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Hydrochlorothiazide; olmesartan medoxomil - Generic Drug Details

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

Hydrochlorothiazide; olmesartan medoxomil is the generic ingredient in two branded drugs marketed by Daiichi Sankyo, Accord Hlthcare, Alembic Pharms Ltd, Aurobindo Pharma Ltd, Mylan, Prinston Inc, Teva Pharms Usa, Torrent, and Umedica Labs Pvt Ltd, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-two drug master file entries for hydrochlorothiazide; olmesartan medoxomil. Twelve suppliers are listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for hydrochlorothiazide; olmesartan medoxomil

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

See all hydrochlorothiazide; olmesartan medoxomil clinical trials

Recent Litigation for hydrochlorothiazide; olmesartan medoxomil

Identify potential future generic entrants

District Court Litigation
Case NameDate
Handley v. Daiichi Sankyo Inc2020-01-23
Apotex Inc. v. Daiichi Sankyo, Inc.2016-05-16
Aurobindo Pharmaceuticals Limited v. Daiici Sankyo, Inc.2016-05-02

See all hydrochlorothiazide; olmesartan medoxomil litigation

Generic filers with tentative approvals for HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial40MG;25MGTABLET;ORAL
  Start Trial  Start Trial40MG;12.5MGTABLET;ORAL
  Start Trial  Start Trial20MG;12.5MGTABLET;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 hydrochlorothiazide; olmesartan medoxomil
Paragraph IV (Patent) Challenges for HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Tradename Dosage Ingredient NDA Submissiondate
BENICAR HCT TABLET;ORAL hydrochlorothiazide; olmesartan medoxomil 021532 2007-05-11
BENICAR HCT TABLET;ORAL hydrochlorothiazide; olmesartan medoxomil 021532 2007-02-15

US Patents and Regulatory Information for hydrochlorothiazide; 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 Pharms Ltd OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 204233-001 Apr 24, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Torrent OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 206515-003 May 3, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Accord Hlthcare OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 209281-002 Feb 7, 2019 DISCN No No   Start Trial   Start Trial   Start Trial
Accord Hlthcare OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 209281-001 Feb 7, 2019 DISCN 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 hydrochlorothiazide; olmesartan medoxomil

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Daiichi Sankyo BENICAR HCT hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 021532-002 Jun 5, 2003   Start Trial   Start Trial
Daiichi Sankyo BENICAR HCT hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 021532-003 Jun 5, 2003   Start Trial   Start Trial
Daiichi Sankyo BENICAR HCT hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 021532-005 Jun 5, 2003   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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