Zafirlukast

Treats asthma. Sold as Accolate. Every FDA application for this active ingredient: 1 branded and 4 generic.

As of Nov 15, 2026, FDA lists 5 applications for Zafirlukast (sold as Accolate), first approved Sep 26, 1996, with 2 new uses approved and 0 published complete response letters.

First approved: Sep 26, 1996
Applications: 5
New uses approved: 2
Complete response letters: 0
Medicare spending, 2025: $6.7M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Zafirlukast	Part D	$6.7M	-5%	15,572

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

ZAFIRLUKAST 10 MG TABLET: $0.542 per unitGeneric · -7% in a year
ZAFIRLUKAST 20 MG TABLET: $0.624 per unitGeneric · -9% in a year

Clinical Trials

1 open or ongoing study names this ingredient as an intervention, including as a comparator; newest first. See all

Study	Phase	Status	Posted
Crossover Study of Zafirlukast in Preventing Allergen-induced Signs and Symptoms in Response to Cat Dander ChallengeAllergy to Cats · Allergy & Asthma Medical Group & Research Center	Phase 2	Not yet recruiting	Oct 5, 2023

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Sep 26, 1996	AccolateNDA 20547 · New molecular entity	Strides Pharma Intl	27	Marketed
Nov 18, 2010	ZafirlukastANDA 90372	Dr Reddys Labs Ltd	2	Marketed
Sep 10, 2020	ZafirlukastANDA 212475	Annora Pharma	0	Marketed
Aug 25, 2022	ZafirlukastANDA 204928	Rising Pharms	0	Marketed
Nov 27, 2023	ZafirlukastANDA 213163	Aurobindo Pharma	0	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA