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Last Updated: August 14, 2020

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Hydrochlorothiazide; triamterene - Generic Drug Details

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What are the generic sources for hydrochlorothiazide; triamterene and what is the scope of freedom to operate?

Hydrochlorothiazide; triamterene is the generic ingredient in four branded drugs marketed by Glaxosmithkline Llc, Ani Pharms Inc, Cadila, Chartwell Rx, Duramed Pharms Barr, Lannett Co Inc, Mylan, Novartis, Sandoz, Vitarine, Mylan Pharms Inc, Am Therap, Apotex Inc, Pliva, Quantum Pharmics, Watson Labs, and Zydus Pharms, and is included in twenty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-two drug master file entries for hydrochlorothiazide; triamterene. Thirty-one suppliers are listed for this compound.

Summary for hydrochlorothiazide; triamterene
Recent Clinical Trials for hydrochlorothiazide; triamterene

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

SponsorPhase
West China HospitalPhase 4
Vanderbilt UniversityN/A
VA Office of Research and DevelopmentN/A

See all hydrochlorothiazide; triamterene clinical trials

Pharmacology for hydrochlorothiazide; triamterene
Paragraph IV (Patent) Challenges for HYDROCHLOROTHIAZIDE; TRIAMTERENE
Tradename Dosage Ingredient NDA Submissiondate
MAXZIDE-25 TABLET;ORAL hydrochlorothiazide; triamterene 019129
MAXZIDE TABLET;ORAL hydrochlorothiazide; triamterene 019129

US Patents and Regulatory Information for hydrochlorothiazide; triamterene

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz TRIAMTERENE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; triamterene TABLET;ORAL 072011-001 Jun 17, 1988 AB RX No No   Start Trial   Start Trial   Start Trial
Zydus Pharms TRIAMTERENE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; triamterene TABLET;ORAL 208360-002 Jun 29, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Am Therap TRIAMTERENE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; triamterene TABLET;ORAL 072022-001 Apr 17, 1988 DISCN No No   Start Trial   Start Trial   Start Trial
Cadila TRIAMTERENE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; triamterene CAPSULE;ORAL 208358-001 Feb 11, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Sandoz TRIAMTERENE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; triamterene TABLET;ORAL 073281-001 Apr 30, 1992 AB RX No No   Start Trial   Start Trial   Start Trial
Glaxosmithkline Llc DYAZIDE hydrochlorothiazide; triamterene CAPSULE;ORAL 016042-002 Approved Prior to Jan 1, 1982 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; triamterene

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan Pharms Inc MAXZIDE hydrochlorothiazide; triamterene TABLET;ORAL 019129-001 Oct 22, 1984   Start Trial   Start Trial
Mylan Pharms Inc MAXZIDE-25 hydrochlorothiazide; triamterene TABLET;ORAL 019129-003 May 13, 1988   Start Trial   Start Trial
Mylan Pharms Inc MAXZIDE hydrochlorothiazide; triamterene TABLET;ORAL 019129-001 Oct 22, 1984   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:

Johnson and Johnson
Mallinckrodt
Merck
Colorcon
Boehringer Ingelheim
Express Scripts

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