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Last Updated: March 19, 2024

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.

Drug Prices for nitazoxanide

See drug prices for nitazoxanide

Recent Clinical Trials for nitazoxanide

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

SponsorPhase
Marwa Ahmed El-SamongyPhase 2/Phase 3
Anahuac UniversityN/A
Sadat City UniversityPhase 1/Phase 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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Romark ALINIA nitazoxanide FOR SUSPENSION;ORAL 021498-001 Nov 22, 2002 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Rising NITAZOXANIDE nitazoxanide TABLET;ORAL 213820-001 Nov 27, 2020 AB RX 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 nitazoxanide

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

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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.