Is there a generic for Nitazoxanide?

Yes. The FDA Orange Book lists 3 approved generic (ANDA) applications for Nitazoxanide, referencing the brand ALINIA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Nitazoxanide?

ALINIA (NDA 021497, ROMARK) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Nitazoxanide are approved?

Nitazoxanide is approved in the following dosage forms: for suspension, tablet.

FDA Orange Book · active-ingredient family

Nitazoxanide

Nitazoxanide is approved as 2 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ALINIA · NDA 021497

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · for suspension, tablet

Product	Applicant	Application	TE	Approved
ALINIARLD	ROMARK	NDA 021497	—	Jul 21, 2004
ALINIARLD	ROMARK	NDA 021498	—	Nov 22, 2002

Generic (ANDA) products (3)

Product	Applicant	Application	TE	Approved
NITAZOXANIDE	ANNORA PHARMA	ANDA 218701	AB	Apr 15, 2025
NITAZOXANIDE	ANI PHARMS	ANDA 214844	AB	Feb 03, 2025
NITAZOXANIDE	RISING	ANDA 213820	AB	Nov 27, 2020

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Nitazoxanide — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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