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Last Updated: February 24, 2021

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Amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil - Generic Drug Details

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

Amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil is the generic ingredient in two branded drugs marketed by Par Pharm Inc, Teva Pharms Usa, Torrent, and Daiichi Sankyo, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are fifty drug master file entries for amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil. Seven suppliers are listed for this compound.

Summary for amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil
Recent Clinical Trials for amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil

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

SponsorPhase
Daiichi Sankyo Inc.Phase 3
Daiichi Sankyo Inc.Phase 4
Sankyo Pharma GmbhPhase 4

See all amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil clinical trials

Pharmacology for amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil

US Patents and Regulatory Information for amlodipine besylate; 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
Torrent OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 203580-005 Oct 26, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Teva Pharms Usa OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 202491-005 Nov 3, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Teva Pharms Usa OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 202491-001 Nov 3, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Daiichi Sankyo TRIBENZOR amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 200175-005 Jul 23, 2010 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Teva Pharms Usa OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 202491-004 Nov 3, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Par Pharm Inc OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 206137-002 Oct 26, 2016 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 amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Mallinckrodt
Dow
Moodys
Merck
Colorcon

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