Is there a generic for Zafirlukast?

Yes. The FDA Orange Book lists 4 approved generic (ANDA) applications for Zafirlukast, referencing the brand ACCOLATE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Zafirlukast?

ACCOLATE (NDA 020547, STRIDES PHARMA INTL) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Zafirlukast are approved?

Zafirlukast is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Zafirlukast

Zafirlukast is approved as 1 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ACCOLATE · NDA 020547

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
ACCOLATERLD×2	STRIDES PHARMA INTL	NDA 020547	AB	Sep 17, 1999

Generic (ANDA) products (4)

Product	Applicant	Application	TE	Approved
ZAFIRLUKAST×2	AUROBINDO PHARMA	ANDA 213163	AB	Nov 27, 2023
ZAFIRLUKAST×2	RISING PHARMS	ANDA 204928	AB	Aug 25, 2022
ZAFIRLUKAST×2	ANNORA PHARMA	ANDA 212475	AB	Sep 10, 2020
ZAFIRLUKAST×2	DR REDDYS LABS LTD	ANDA 090372	AB	Nov 18, 2010

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.

Zafirlukast — frequently asked questions

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

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo