Last Updated: June 17, 2026

TRANDATE Drug Patent Profile

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When do Trandate patents expire, and what generic alternatives are available?

Trandate is a drug marketed by Sebela Ireland Ltd, Alvogen, and Glaxosmithkline. and is included in three NDAs.

The generic ingredient in TRANDATE 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.

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Summary for TRANDATE

US Patents:	0
Applicants:	3
NDAs:	3

US Patents and Regulatory Information for TRANDATE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sebela Ireland Ltd	TRANDATE	labetalol hydrochloride	INJECTABLE;INJECTION	019425-001	Dec 31, 1985		DISCN	Yes	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
Alvogen	TRANDATE	labetalol hydrochloride	TABLET;ORAL	018716-003	Aug 1, 1984		DISCN	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Glaxosmithkline	TRANDATE HCT	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019174-003	Apr 10, 1987		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Alvogen	TRANDATE	labetalol hydrochloride	TABLET;ORAL	018716-001	May 24, 1985		DISCN	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Alvogen	TRANDATE	labetalol hydrochloride	TABLET;ORAL	018716-002	Aug 1, 1984		DISCN	Yes	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

International Patents for TRANDATE

See the table below for patents covering TRANDATE around the world.

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Country	Patent Number	Title	Estimated Expiration
Sweden	372935		⤷ Start Trial
Canada	983524	PHENYLAMINOETHANOL DERIVATIVES	⤷ Start Trial
Netherlands	7010126		⤷ Start Trial
Netherlands	160805		⤷ Start Trial
Yugoslavia	86768		⤷ Start Trial
Malaysia	7400003	PHENYLAMINOETHANOL DERIVATIVES	⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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