Viewing data from:

ACCOLATE

NDA

ZAFIRLUKAST | N020547 | STRIDES PHARMA INTERNATIONAL AG

2 strengths0 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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

3 trials from ClinicalTrials.gov, 2 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Bioequivalence Study of Zafirlukast Tablets 20 mg of Dr. Reddy's Laboratories Limited Under Fasting Condition NCT01283061	Phase 1	Completed	Dr. Reddy's Laboratories Limited	44	2007-12 → 2008-01
Zafirlukast in Treatment of Marker Relapsed Ovarian Cancer NCT04339140	Phase 2	Completed	Beth Israel Deaconess Medical Center	5	2020-06-24 → 2024-12-31
Breast Capsular Contracture Following Post-Mastectomy Reconstruction in Women Treated With the Leukotriene Inhibitor Zafirlukast: A Phase II Trial NCT02950480	Phase 2	Terminated	University of California, San Francisco	4	2017-03-13 → 2018-12-20

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$0.6762

per ea

Lowest NADAC/Unit

$0.5414

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
64380018801ZAFIRLUKAST 20 MG TABLET	$0.6762	EA	Generic	—	2026-06-17
64380018701ZAFIRLUKAST 10 MG TABLET	$0.5414	EA	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (2 FSS)

Lowest Price

$58.30

Highest Price

$69.43

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
42291-0970-60ZAFIRLUKAST 10MG TAB	$69.43	FSS	AvKare, LLC	06/14/2028
42291-0971-60ZAFIRLUKAST 20MG TAB	$58.30	FSS	AvKare, LLC	06/14/2028

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data across 2 drug listings matched to this application (2024)

Zafirlukast (2024)

Total Spending

$7.0M

Total Claims

66,341

Beneficiaries

15,521

Avg Cost/Unit

$1.00

YoY Change:-28.3%

5yr CAGR:-7.2%

Accolate (2023)

Total Spending

$8K

Total Claims

Beneficiaries

Avg Cost/Unit

$3.69

Spending Trend

$267K(2019)→$242K(2020)→$217K(2021)→$150K(2022)→$8K(2023)

YoY Change:-0.9%

5yr CAGR:-0.5%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain4 active DMFs

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

DR REDDYS LABORATORIES LTDZAFIRLUKAST (AMORPHOUS)

DMF 213132008

CHROMO LABORATORIES INDIA PRIVATE LTDZAFIRLUKAST PREMIX-50% W/W

DMF 263592012

CHROMO LABORATORIES INDIA PRIVATE LTDZAFIRLUKAST

DMF 318692017

HETERO DRUGS LTDZAFIRLUKAST (AMORPHOUS)

DMF 324152018

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

Approval Letters

10 letters from Drugs@FDA

Date	Submission	Document
Nov 18, 2013	SUPPL -33	View Letter (PDF)
Aug 10, 2011	SUPPL -31	View Letter (PDF)
Oct 19, 2010	SUPPL -30	View Letter (PDF)
Jul 15, 2010	SUPPL -29	View Letter (PDF)
Nov 19, 2009	SUPPL -27	View Letter (PDF)
Jun 2, 2008	SUPPL -25	View Letter (PDF)
Jun 8, 2005	SUPPL -22	View Letter (PDF)
May 25, 2004	SUPPL -17	View Letter (PDF)
Jul 29, 2003	SUPPL -14	View Letter (PDF)
Sep 17, 1999	SUPPL -7	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 20MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Sep 26, 1996

No patent or exclusivity listings for this strength.

#003 — 10MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 17, 1999