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Last Updated: January 17, 2020

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TRANDATE HCT Drug Profile

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When do Trandate Hct patents expire, and when can generic versions of Trandate Hct launch?

Trandate Hct is a drug marketed by Glaxosmithkline and is included in one NDA.

The generic ingredient in TRANDATE HCT is hydrochlorothiazide; labetalol hydrochloride. There are thirty-two drug master file entries for this compound. Additional details are available on the hydrochlorothiazide; labetalol hydrochloride profile page.

Summary for TRANDATE HCT
US Patents:0
Applicants:1
NDAs:1
Clinical Trials: 5
Formulation / Manufacturing:see details
DailyMed Link:TRANDATE HCT at DailyMed
Drug patent expirations by year for TRANDATE HCT
Recent Clinical Trials for TRANDATE HCT

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

SponsorPhase
High Risk Obstetrical ConsultantsEarly Phase 1
University of Tennessee Graduate School of MedicineEarly Phase 1
Maastricht University Medical CenterPhase 4

See all TRANDATE HCT clinical trials

US Patents and Regulatory Information for TRANDATE HCT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline TRANDATE HCT hydrochlorothiazide; labetalol hydrochloride TABLET;ORAL 019174-001 Apr 10, 1987 DISCN No No   Start Trial   Start Trial   Start Trial
Glaxosmithkline TRANDATE HCT hydrochlorothiazide; labetalol hydrochloride TABLET;ORAL 019174-004 Apr 10, 1987 DISCN No No   Start Trial   Start Trial   Start Trial
Glaxosmithkline TRANDATE HCT hydrochlorothiazide; labetalol hydrochloride TABLET;ORAL 019174-002 Apr 10, 1987 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 TRANDATE HCT

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline TRANDATE HCT hydrochlorothiazide; labetalol hydrochloride TABLET;ORAL 019174-003 Apr 10, 1987   Start Trial   Start Trial
Glaxosmithkline TRANDATE HCT hydrochlorothiazide; labetalol hydrochloride TABLET;ORAL 019174-001 Apr 10, 1987   Start Trial   Start Trial
Glaxosmithkline TRANDATE HCT hydrochlorothiazide; labetalol hydrochloride TABLET;ORAL 019174-004 Apr 10, 1987   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:

McKinsey
Express Scripts
Moodys
Mallinckrodt
Boehringer Ingelheim
AstraZeneca

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