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Last Updated: July 21, 2024

ALINIA Drug Patent Profile


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Which patents cover Alinia, and when can generic versions of Alinia launch?

Alinia is a drug marketed by Romark and is included in two NDAs.

The generic ingredient in ALINIA is nitazoxanide. There are five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the nitazoxanide profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Alinia

A generic version of ALINIA was approved as nitazoxanide by RISING on November 27th, 2020.

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Drug patent expirations by year for ALINIA
Drug Prices for ALINIA

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Recent Clinical Trials for ALINIA

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

SponsorPhase
University of VirginiaPhase 2/Phase 3
Bill and Melinda Gates FoundationPhase 2/Phase 3
Haydom Lutheran HospitalPhase 2/Phase 3

See all ALINIA clinical trials

Pharmacology for ALINIA
Drug ClassAntiprotozoal

US Patents and Regulatory Information for ALINIA

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 FOR SUSPENSION;ORAL 021498-001 Nov 22, 2002 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Romark ALINIA nitazoxanide TABLET;ORAL 021497-001 Jul 21, 2004 AB RX Yes Yes ⤷  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 ALINIA

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

International Patents for ALINIA

See the table below for patents covering ALINIA around the world.

Country Patent Number Title Estimated Expiration
Lithuania 4751 TIZOKSANIDO IR NITAZOKSANIDO FARMACINĖS KOMPOZICIJOS ⤷  Sign Up
Eurasian Patent Organization 199901012 ⤷  Sign Up
Austria 228839 ⤷  Sign Up
Czech Republic 9602959 ⤷  Sign Up
Finland 964031 ⤷  Sign Up
Cuba 23318 COMPOSICIONES FARMACÃ0/00UTICAS DE LA TIZOXANIDA Y NITAZOXANIDA ⤷  Sign Up
>Country >Patent Number >Title >Estimated 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.