NITAZOXANIDE - Generic Drug Details

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What are the generic sources for nitazoxanide and what is the scope of patent protection?

Nitazoxanide is the generic ingredient in two branded drugs marketed by Romark and Rising, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for nitazoxanide. One supplier is listed for this compound.

Summary for NITAZOXANIDE

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	3
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	122
Clinical Trials:	99
Patent Applications:	5,396
Drug Prices:	Drug price trends for NITAZOXANIDE
What excipients (inactive ingredients) are in NITAZOXANIDE?	NITAZOXANIDE excipients list
DailyMed Link:	NITAZOXANIDE at DailyMed

See drug prices for NITAZOXANIDE

Recent Clinical Trials for NITAZOXANIDE

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

Sponsor	Phase
Marwa Ahmed El-Samongy	Phase 2/Phase 3
Anahuac University	N/A
Sadat City University	Phase 1/Phase 2

See all NITAZOXANIDE clinical trials

Pharmacology for NITAZOXANIDE

Drug Class	Antiprotozoal

Anatomical Therapeutic Chemical (ATC) Classes for NITAZOXANIDE

P01AX	Other agents against amoebiasis and other protozoal diseases
P01A	AGENTS AGAINST AMOEBIASIS AND OTHER PROTOZOAL DISEASES
P01	ANTIPROTOZOALS
P	Antiparasitic products, insecticides and repellents

US Patents and Regulatory Information for NITAZOXANIDE

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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
Romark	ALINIA	nitazoxanide	TABLET;ORAL	021497-001	Jul 21, 2004		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rising	NITAZOXANIDE	nitazoxanide	TABLET;ORAL	213820-001	Nov 27, 2020		RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Romark	ALINIA	nitazoxanide	FOR SUSPENSION;ORAL	021498-001	Nov 22, 2002		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 NITAZOXANIDE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Romark	ALINIA	nitazoxanide	TABLET;ORAL	021497-001	Jul 21, 2004	⤷ Sign Up	⤷ Sign Up
Romark	ALINIA	nitazoxanide	TABLET;ORAL	021497-001	Jul 21, 2004	⤷ Sign Up	⤷ Sign Up
Romark	ALINIA	nitazoxanide	FOR SUSPENSION;ORAL	021498-001	Nov 22, 2002	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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