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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for 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 (2023). 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