NIZATIDINE - Generic Drug Details

✉ Email this page to a colleague

What are the generic drug sources for nizatidine and what is the scope of freedom to operate?

Nizatidine is the generic ingredient in three branded drugs marketed by Smithkline Beecham, Ani Pharms, Apotex Inc, Dr Reddys Labs Ltd, Epic Pharma Llc, Glenmark Pharms Inc, Mylan Pharms Inc, Norvium Bioscience, Watson Labs, Braintree, Amneal Pharms, and Haleon Us Holdings, and is included in thirteen NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for nizatidine. Four suppliers are listed for this compound.

Summary for NIZATIDINE

US Patents:	0
Tradenames:	3
Applicants:	12
NDAs:	13
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	82
Clinical Trials:	9
Patent Applications:	6,987
Drug Prices:	Drug price trends for NIZATIDINE
What excipients (inactive ingredients) are in NIZATIDINE?	NIZATIDINE excipients list
DailyMed Link:	NIZATIDINE at DailyMed

See drug prices for NIZATIDINE

Recent Clinical Trials for NIZATIDINE

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

Sponsor	Phase
Daewoong Pharmaceutical Co. LTD.	Phase 4
National Center for Research Resources (NCRR)	Phase 1
Adil Bharucha	Phase 1

See all NIZATIDINE clinical trials

Pharmacology for NIZATIDINE

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

Medical Subject Heading (MeSH) Categories for NIZATIDINE

Anti-Ulcer Agents
Histamine H2 Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for NIZATIDINE

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

Paragraph IV (Patent) Challenges for NIZATIDINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AXID	Oral Solution	nizatidine	15 mg/mL	021494	1	2008-05-14

US Patents and Regulatory Information for NIZATIDINE

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glenmark Pharms Inc	NIZATIDINE	nizatidine	CAPSULE;ORAL	090618-001	Jul 15, 2011	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glenmark Pharms Inc	NIZATIDINE	nizatidine	CAPSULE;ORAL	090618-002	Jul 15, 2011	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Apotex Inc	NIZATIDINE	nizatidine	CAPSULE;ORAL	076383-001	Jan 23, 2003		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Norvium Bioscience	NIZATIDINE	nizatidine	CAPSULE;ORAL	075806-001	Jul 5, 2002		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Smithkline Beecham	AXID	nizatidine	CAPSULE;ORAL	019508-001	Apr 12, 1988		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Braintree	AXID	nizatidine	SOLUTION;ORAL	021494-001	May 25, 2004		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

Expired US Patents for NIZATIDINE

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Smithkline Beecham	AXID	nizatidine	CAPSULE;ORAL	019508-002	Apr 12, 1988	⤷ Sign Up	⤷ Sign Up
Haleon Us Holdings	AXID AR	nizatidine	TABLET;ORAL	020555-001	May 9, 1996	⤷ Sign Up	⤷ Sign Up
Smithkline Beecham	AXID	nizatidine	CAPSULE;ORAL	019508-001	Apr 12, 1988	⤷ Sign Up	⤷ Sign Up
Smithkline Beecham	AXID	nizatidine	CAPSULE;ORAL	019508-002	Apr 12, 1988	⤷ Sign Up	⤷ Sign Up
Braintree	AXID	nizatidine	SOLUTION;ORAL	021494-001	May 25, 2004	⤷ Sign Up	⤷ Sign Up
Smithkline Beecham	AXID	nizatidine	CAPSULE;ORAL	019508-001	Apr 12, 1988	⤷ Sign Up	⤷ Sign Up
>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.