ZANTAC Drug Patent Profile

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Zantac is a drug marketed by Pai Holdings Pharm, Glaxo Grp Ltd, Glaxosmithkline, and Chattem Sanofi. and is included in nine NDAs.

The generic ingredient in ZANTAC is ranitidine hydrochloride. There are forty-three drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the ranitidine hydrochloride profile page.

A generic version of ZANTAC was approved as ranitidine hydrochloride by SANDOZ on August 29^th, 1997.

US Patents:	0
Applicants:	4
NDAs:	9
Raw Ingredient (Bulk) Api Vendors:	212
Clinical Trials:	22
Patent Applications:	4,046
Drug Prices:	Drug price information for ZANTAC
What excipients (inactive ingredients) are in ZANTAC?	ZANTAC excipients list
DailyMed Link:	ZANTAC at DailyMed

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

Sponsor	Phase
Food and Drug Administration (FDA)	Phase 1
Spaulding Clinical Research LLC	Phase 1
Lisa Barrett	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
Pai Holdings Pharm	ZANTAC	ranitidine hydrochloride	INJECTABLE;INJECTION	019090-001	Oct 19, 1984		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Chattem Sanofi	ZANTAC 150	ranitidine hydrochloride	TABLET;ORAL	021698-002	Mar 13, 2007		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glaxo Grp Ltd	ZANTAC 150	ranitidine hydrochloride	GRANULE, EFFERVESCENT;ORAL	020251-002	Mar 31, 1994		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Chattem Sanofi	ZANTAC 75	ranitidine hydrochloride	TABLET, EFFERVESCENT;ORAL	020745-001	Feb 26, 1998		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glaxo Grp Ltd	ZANTAC 150	ranitidine hydrochloride	TABLET;ORAL	018703-001	Jun 9, 1983		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pai Holdings Pharm	ZANTAC IN PLASTIC CONTAINER	ranitidine hydrochloride	INJECTABLE;INJECTION	019593-002	Sep 27, 1991		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glaxo Grp Ltd	ZANTAC	ranitidine hydrochloride	SYRUP;ORAL	019675-001	Dec 30, 1988		DISCN	Yes	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
Pai Holdings Pharm	ZANTAC	ranitidine hydrochloride	INJECTABLE;INJECTION	019090-001	Oct 19, 1984	⤷ Sign Up	⤷ Sign Up
Glaxo Grp Ltd	ZANTAC	ranitidine hydrochloride	SYRUP;ORAL	019675-001	Dec 30, 1988	⤷ Sign Up	⤷ Sign Up
Glaxo Grp Ltd	ZANTAC	ranitidine hydrochloride	SYRUP;ORAL	019675-001	Dec 30, 1988	⤷ Sign Up	⤷ Sign Up
Glaxo Grp Ltd	ZANTAC	ranitidine hydrochloride	SYRUP;ORAL	019675-001	Dec 30, 1988	⤷ Sign Up	⤷ Sign Up
Glaxo Grp Ltd	ZANTAC	ranitidine hydrochloride	SYRUP;ORAL	019675-001	Dec 30, 1988	⤷ Sign Up	⤷ Sign Up
Pai Holdings Pharm	ZANTAC	ranitidine hydrochloride	INJECTABLE;INJECTION	019090-001	Oct 19, 1984	⤷ Sign Up	⤷ Sign Up
Pai Holdings Pharm	ZANTAC	ranitidine hydrochloride	INJECTABLE;INJECTION	019090-001	Oct 19, 1984	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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

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Country	Patent Number	Title	Estimated Expiration
Slovakia	277922		⤷ Sign Up
Italy	1179367	COMPOSIZIONI FARMACEUTICHE CONTENENTI RANITIDINA E PROCEDIMENTO PER PREPARARLE	⤷ Sign Up
Philippines	25390	PHARMACEUTICAL COMPOSITIONS	⤷ Sign Up
Sweden	8704952		⤷ Sign Up
Philippines	20574	PHARMACEUTICAL COMPOSITIONS	⤷ Sign Up
Canada	1303993	COMPOSITIONS PHARMACEUTIQUES CONTENANT DE LA RANITIDINE (PHARMACEUTICAL COMPOSITIONS CONTAINING RANITIDINE)	⤷ Sign Up
Switzerland	641176	Process for preparing aminoalkylfuran derivatives	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration