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ALINIA

NDA

NITAZOXANIDE | N021498 | ROMARK LABORATORIES

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

3 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Foley & Lardner, LLP. on behalf of Romark Laboratories,... FDA-2020-P-0599 · 4 docket documents Foley & Lardner LLP, on behalf of Romark Laboratories, L.C., filed this citizen petition under sections 505(b) and 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA not approve any abbreviated new drug application for generic versions of ALINIA (nitazoxanide) tablets or oral	505(q)	2020-02-04	Denied	Romark Laboratories, L.C.
Citizen Petition from Foley and Lardner LLP on behalf of Romark Laboratories,... FDA-2020-P-0513 · 3 docket documents Foley and Lardner LLP filed this citizen petition on behalf of Romark Laboratories, L.C., requesting that the FDA not approve any abbreviated new drug application for generic versions of ALINIA (nitazoxanide) tablets or oral suspension unless applicants conduct bioequivalence studies of both active	505(q)	2020-01-31	Withdrawn	Romark Laboratories, L.C.
Citizen Petition from Foley and Lardner LLP on behalf of Romark Laboratories,... FDA-2020-P-0436 · 3 docket documents Foley and Lardner LLP on behalf of Romark Laboratories submitted this citizen petition under sections 505(b) and 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that FDA not approve any ANDA for generic versions of Alinia (nitazoxanide) tablets or oral suspension unless applicants cond	505(q)	2020-01-27	Withdrawn	Romark Laboratories, L.C.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

57 trials from ClinicalTrials.gov — 1 recruiting, 38 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Efficacy and Safety of Nitazoxanide in Preventing Recurrence of Hepatic Encephalopathy NCT04161053	Phase 3	Recruiting	Tanta University	60	2018-11-01 → 2028-12
Study of Nitazoxanide in the Treatment of Amebiasis in Adults and Adolescents NCT00366236	Phase 3	Completed	Romark Laboratories L.C.	50	2004-02 → 2005-11
Study of Nitazoxanide in the Treatment of Chronic Hepatitis C NCT00418639	Phase 2	Completed	Romark Laboratories L.C.	50	2005-02
A Safety and Tolerability Study of Nitazoxanide in HIV-HCV Treatment Failures NCT01185028	Phase 1/2	Completed	National Institutes of Health Clinical Center (CC)	8	2010-08 → 2011-10
Efficacy of Nitazoxanide in the Treatment of Chronic Hepatitis C Virus (HCV)NCT01276756	Phase 2/3	Completed	Cairo University	100	2010-12 → 2012-11
Nitazoxanide Versus Placebo for the Treatment of Hospitalized Subjects With Severe Acute Respiratory Illness NCT02057757	Phase 2	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	260	2014-02 → 2018-01
Efficacy and Safety of Nitazoxanide in the Treatment of Colds Due to Enterovirus/Rhinovirus Infection NCT03605862	Phase 3	Completed	Romark Laboratories L.C.	1,756	2018-09-11 → 2019-02-04
Study of Nitazoxanide, Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Hepatitis C Patients NCT00637923	Phase 2	Completed	Romark Laboratories L.C.	112	2008-03 → 2010-04
A Phase III, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Nitazoxanide in the Treatment of Uncomplicated Influenza NCT03336619	Phase 3	Completed	Romark Laboratories L.C.	1,030	2018-01-17 → 2019-04-17
Efficacy and Safety of Nitazoxanide for the Treatment of Hospitalized Patients With Moderate COVID-19 NCT04348409	N/A	Completed	Azidus Brasil	50	2020-05-25 → 2020-12-31

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain9 active DMFs1 inactive

9 active API suppliers hold Drug Master Files for this ingredient.

ROMARK BELGIUM BVBANITAZOXANIDE

DMF 121241996

COHANCE LIFESCIENCES LTDNITAZOXANIDE

DMF 197522006

INDUSTRIALE CHIMICA SRLNITAZOXANIDE

DMF 237922010

DASAMI LAB PRIVATE LTDNITAZOXANIDE

DMF 330592019

MAPRIMED SANITAZOXANIDE

DMF 341502019

BIOPHORE INDIA PHARMACEUTICALS PVT LTDNITAZOXANIDE

DMF 341692019

MSN LIFE SCIENCES PRIVATE LTDNITAZOXANIDE

DMF 345552020

NIRA LIFE SCIENCES PVT LTDNITAZOXANIDE

DMF 384082023

SUN PHARMACEUTICAL INDUSTRIES LTDNITAZOXANIDE

DMF 389962023

CAMBREX PROFARMACO MILANO SRLInactiveNITAZOXANIDE

DMF 315412016

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Jul 12, 2016	SUPPL -4	View Letter (PDF)
Jun 21, 2005	SUPPL -3	View Letter (PDF)
Jul 21, 2004	SUPPL -1	View Letter (PDF)
Nov 22, 2002	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100MG/5ML

RLD

0 patents0 exclusivities▴

FOR SUSPENSION;ORAL | Approved: Nov 22, 2002

No patent or exclusivity listings for this strength.