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Last Updated: March 4, 2021

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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. Three suppliers are listed for this compound.

Summary for nitazoxanide
US Patents:0
Tradenames:2
Applicants:2
NDAs:3
Drug Master File Entries: 5
Suppliers / Packagers: 3
Bulk Api Vendors: 105
Clinical Trials: 76
Patent Applications: 5,043
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in nitazoxanide?nitazoxanide excipients list
DailyMed Link:nitazoxanide at DailyMed
Recent Clinical Trials for nitazoxanide

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

SponsorPhase
University of Witwatersrand, South AfricaPhase 2
SynaVirPhase 2
Rutgers, The State University of New JerseyPhase 2

See all nitazoxanide clinical trials

Pharmacology for nitazoxanide
Drug ClassAntiprotozoal

US Patents and Regulatory Information for nitazoxanide

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 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Romark ALINIA nitazoxanide FOR SUSPENSION;ORAL 021498-001 Nov 22, 2002 RX Yes Yes   Start Trial   Start Trial   Start Trial
Rising NITAZOXANIDE nitazoxanide TABLET;ORAL 213820-001 Nov 27, 2020 AB RX No No   Start Trial   Start Trial   Start 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 nitazoxanide

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

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