Is there a generic for Zileuton?

Yes. The FDA Orange Book lists 6 approved generic (ANDA) applications for Zileuton, referencing the brand ZYFLO CR. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Zileuton?

ZYFLO CR (NDA 022052, CHIESI) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Zileuton are approved?

Zileuton is approved in the following dosage forms: tablet, tablet, extended release.

FDA Orange Book · active-ingredient family

Zileuton

Zileuton is approved as 2 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ZYFLO CR · NDA 022052

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet, tablet, extended release

Product	Applicant	Application	TE	Approved
ZYFLO CRRLD	CHIESI	NDA 022052	—	May 30, 2007
ZYFLORLD×2	CHIESI	NDA 020471	—	Dec 09, 1996

Generic (ANDA) products (6)

Product	Applicant	Application	TE	Approved
ZILEUTON	ANNORA PHARMA	ANDA 215742	AB	Oct 11, 2022
ZILEUTON	TEVA PHARMS USA	ANDA 211043	—	May 03, 2022
ZILEUTON	AIZANT	ANDA 211390	AB	Oct 23, 2020
ZILEUTON	STRIDES PHARMA INTL	ANDA 212670	AB	Dec 16, 2019
ZILEUTON	LUPIN	ANDA 211972	—	Nov 05, 2019
ZILEUTON	RISING	ANDA 204929	AB	Mar 17, 2017

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.

Zileuton — frequently asked questions

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

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