NIZATIDINE - Generic Drug Details

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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

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Glossary

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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
Epic Pharma Llc	NIZATIDINE	nizatidine	CAPSULE;ORAL	076178-001	Jul 5, 2002	AB	RX	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
Norvium Bioscience	NIZATIDINE	nizatidine	CAPSULE;ORAL	075806-002	Jul 5, 2002		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

Expired US Patents for NIZATIDINE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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
Smithkline Beecham	AXID	nizatidine	CAPSULE;ORAL	019508-002	Apr 12, 1988	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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