TRANDATE Drug Patent Profile

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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.

US Patents:	0
Applicants:	3
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	10
Patent Applications:	804
What excipients (inactive ingredients) are in TRANDATE?	TRANDATE excipients list
DailyMed Link:	TRANDATE at DailyMed

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

Sponsor	Phase
Loma Linda University	N/A
Nebraska Methodist Health System	Phase 4
Wright State University	Phase 4

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glaxosmithkline	TRANDATE HCT	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019174-002	Apr 10, 1987		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alvogen	TRANDATE	labetalol hydrochloride	TABLET;ORAL	018716-003	Aug 1, 1984		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glaxosmithkline	TRANDATE HCT	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019174-003	Apr 10, 1987		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alvogen	TRANDATE	labetalol hydrochloride	TABLET;ORAL	018716-001	May 24, 1985		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alvogen	TRANDATE	labetalol hydrochloride	TABLET;ORAL	018716-002	Aug 1, 1984		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glaxosmithkline	TRANDATE HCT	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019174-001	Apr 10, 1987		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sebela Ireland Ltd	TRANDATE	labetalol hydrochloride	INJECTABLE;INJECTION	019425-001	Dec 31, 1985	⤷ Sign Up	⤷ Sign Up
Alvogen	TRANDATE	labetalol hydrochloride	TABLET;ORAL	018716-001	May 24, 1985	⤷ Sign Up	⤷ Sign Up
Alvogen	TRANDATE	labetalol hydrochloride	TABLET;ORAL	018716-002	Aug 1, 1984	⤷ Sign Up	⤷ Sign Up
Alvogen	TRANDATE	labetalol hydrochloride	TABLET;ORAL	018716-003	Aug 1, 1984	⤷ Sign Up	⤷ Sign Up
Alvogen	TRANDATE	labetalol hydrochloride	TABLET;ORAL	018716-003	Aug 1, 1984	⤷ Sign Up	⤷ Sign Up
Alvogen	TRANDATE	labetalol hydrochloride	TABLET;ORAL	018716-004	Aug 1, 1984	⤷ Sign Up	⤷ Sign Up
Alvogen	TRANDATE	labetalol hydrochloride	TABLET;ORAL	018716-004	Aug 1, 1984	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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

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Country	Patent Number	Title	Estimated Expiration
Czechoslovakia	167874		⤷ Sign Up
Netherlands	6713016		⤷ Sign Up
Malaysia	7400003	PHENYLAMINOETHANOL DERIVATIVES	⤷ Sign Up
Netherlands	7010126		⤷ Sign Up
France	2059495		⤷ Sign Up
France	1557677		⤷ Sign Up
Germany	2032642	1-PHENYL-2-AMINOAETHANOL-DERIVATE, VERFAHREN ZU IHRER HERSTELLUNG UND DIESE VERBINDUNGEN ENTHALTENDE ARZNEIMITTEL	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration