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Last Updated: March 4, 2021

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ALINIA Drug 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.

US ANDA 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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Summary for ALINIA
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
Bill and Melinda Gates FoundationPhase 2/Phase 3
University of VirginiaPhase 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   Start Trial   Start Trial   Start Trial
Romark ALINIA nitazoxanide TABLET;ORAL 021497-001 Jul 21, 2004 AB RX Yes Yes   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 ALINIA

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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Serving leading biopharmaceutical companies globally:

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Medtronic
Harvard Business School

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