You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: April 19, 2024

RANITIDINE HYDROCHLORIDE - Generic Drug Details

✉ Email this page to a colleague

« Back to Dashboard

What are the generic drug sources for ranitidine hydrochloride and what is the scope of patent protection?

Ranitidine hydrochloride is the generic ingredient in seven branded drugs marketed by Ajanta Pharma Ltd, Appco, Aurobindo Pharma, Dr Reddys Labs Ltd, Mylan, Novitium Pharma, Sandoz, Teva, Glaxosmithkline, Glaxo Grp Ltd, Bedford, Hikma, Mylan Labs Ltd, Zydus Pharms Usa Inc, Pai Holdings Pharm, Actavis Mid Atlantic, Amneal Pharms, Apotex Inc, Epic Pharma Llc, Lannett Co Inc, Nostrum Labs Inc, Pharm Assoc, Ranbaxy, Taro, Tolmar, Torrent, Wockhardt, Chattem Sanofi, Amneal Pharms Ny, Ani Pharms, Apotex, Boehringer Ingelheim, Contract Pharmacal, Dr Reddys Labs Inc, Glenmark Pharms Inc, Granules, Heritage Pharma Avet, Par Pharm, Perrigo, Perrigo R And D, Strides Pharma, Sun Pharm Inds Ltd, Thinq Pharm-cro Pvt, Vkt Pharma, Watson Labs, and Wockhardt Ltd, and is included in eighty-four NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-two drug master file entries for ranitidine hydrochloride. Thirteen suppliers are listed for this compound.

Summary for RANITIDINE HYDROCHLORIDE

US Patents:	0
Tradenames:	7
Applicants:	46
NDAs:	84
Drug Master File Entries:	32
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	169
Clinical Trials:	138
Patent Applications:	3,200
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in RANITIDINE HYDROCHLORIDE?	RANITIDINE HYDROCHLORIDE excipients list
DailyMed Link:	RANITIDINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for RANITIDINE HYDROCHLORIDE

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

Sponsor	Phase
Menoufia University	Phase 2/Phase 3
Cairo University	N/A
University of Sao Paulo General Hospital	Phase 3

See all RANITIDINE HYDROCHLORIDE clinical trials

Pharmacology for RANITIDINE HYDROCHLORIDE

Drug Class	Histamine-2 Receptor Antagonist
Mechanism of Action	Histamine H2 Receptor Antagonists

US Patents and Regulatory Information for RANITIDINE HYDROCHLORIDE

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or 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
Chattem Sanofi	ZANTAC 150	ranitidine hydrochloride	TABLET;ORAL	021698-001	Aug 31, 2004		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Novitium Pharma	RANITIDINE HYDROCHLORIDE	ranitidine hydrochloride	CAPSULE;ORAL	210681-001	Nov 23, 2018		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Apotex	RANITIDINE HYDROCHLORIDE	ranitidine hydrochloride	TABLET;ORAL	074680-002	Sep 12, 1997	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Watson Labs	RANITIDINE HYDROCHLORIDE	ranitidine hydrochloride	TABLET;ORAL	074864-001	Oct 20, 1997		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Thinq Pharm-cro Pvt	RANITIDINE HYDROCHLORIDE	ranitidine hydrochloride	TABLET;ORAL	210228-001	Aug 30, 2019		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

Expired US Patents for RANITIDINE HYDROCHLORIDE

Subscribe to access the full database, or Try a Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	ZANTAC 150	ranitidine hydrochloride	CAPSULE;ORAL	020095-001	Mar 8, 1994	⤷ Try a Trial	⤷ Try a Trial
Glaxosmithkline	ZANTAC 300	ranitidine hydrochloride	CAPSULE;ORAL	020095-002	Mar 8, 1994	⤷ Try a Trial	⤷ Try a Trial
Pai Holdings Pharm	ZANTAC IN PLASTIC CONTAINER	ranitidine hydrochloride	INJECTABLE;INJECTION	019593-001	Dec 17, 1986	⤷ Try a Trial	⤷ Try a Trial
Glaxosmithkline	ZANTAC 300	ranitidine hydrochloride	CAPSULE;ORAL	020095-002	Mar 8, 1994	⤷ Try a Trial	⤷ Try a Trial
Pai Holdings Pharm	ZANTAC IN PLASTIC CONTAINER	ranitidine hydrochloride	INJECTABLE;INJECTION	019593-001	Dec 17, 1986	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.