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. Thirteen 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:	3,817
Formulation / Manufacturing:	see details
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
Nova Scotia Health Authority	Phase 4

A02BA	H2-receptor antagonists
A02B	DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
A02	DRUGS FOR ACID RELATED DISORDERS
A	Alimentary tract and metabolism

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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	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Chattem Sanofi	ZANTAC 150	ranitidine hydrochloride	TABLET;ORAL	021698-002	Mar 13, 2007		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Glaxo Grp Ltd	ZANTAC 150	ranitidine hydrochloride	GRANULE, EFFERVESCENT;ORAL	020251-002	Mar 31, 1994		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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
Glaxo Grp Ltd	ZANTAC	ranitidine hydrochloride	SYRUP;ORAL	019675-001	Dec 30, 1988	⤷ Try a Trial	⤷ Try a Trial
Pai Holdings Pharm	ZANTAC	ranitidine hydrochloride	INJECTABLE;INJECTION	019090-001	Oct 19, 1984	⤷ Try a Trial	⤷ Try a Trial
Glaxo Grp Ltd	ZANTAC	ranitidine hydrochloride	SYRUP;ORAL	019675-001	Dec 30, 1988	⤷ Try a Trial	⤷ Try a Trial
>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
Japan	S55153779	NOVEL AMINES	⤷ Try a Trial
Japan	S63215622	MEDICINAL COMPOSITION	⤷ Try a Trial
Guatemala	197960582	NUEVOS DERIVADOS DE AMINOALQUILFURANO,PROCEDIMIENTO PARA SU PREPARACION, ASI COMO SU EMPLEO EN TERAPEUTICA	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration