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AZULFIDINE

NDA

SULFASALAZINE | N007073 | PFIZER INC

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

2 trials from ClinicalTrials.gov — 1 recruiting, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Validation of Hemoglobin A1c in Patients With Inflammatory Arthritis Treated With Sulfasalazine NCT07416656	—	Recruiting	Klavs Würgler Hansen	75	2026-03-10 → 2026-10
Multicentre ObservatioNal Initiative in Treat to Target Outcomes in Psoriatic Arthritis NCT03531073	—	Completed	University of Oxford	446	2018-04-18 → 2024-12-31

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

Medicare Part D Spending

CMS annual spending data for Azulfidine (2023)

Total Spending

$272K

Total Claims

601

Beneficiaries

204

Avg Cost/Unit

$1.79

Spending Trend

$368K(2019)→$387K(2020)→$580K(2021)→$433K(2022)→$272K(2023)

YoY Change:+0.5%

5yr CAGR:+1.3%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain2 active DMFs6 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

CAMBREX CHARLES CITY INCSULFASALAZINE USP

DMF 22391974

VALENS MOLECULES PRIVATE LTDSULFASALAZINE USP

DMF 261272012

ACF CHEMIEFARMA NVInactiveSULFASALAZINE

DMF 64891986

IFP INCInactiveSULFASALAZINE STARCH POWDER

DMF 71271987

CORDEN PHARMA BERGAMO SPAInactiveSULFASALAZINE

DMF 111631994

SALSBURY CHEMICALS INCInactiveSULFASALAZINE PVP

DMF 146882000

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTDInactiveSULFASALAZINE

DMF 147242000

SHANGHAI ZHONGXI SUNVE PHARMACEUTICAL CO LTDInactiveSULFASALAZINE

DMF 222382008

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

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Nov 17, 2022	SUPPL -133	View Letter (PDF)
Nov 2, 2021	SUPPL -130	View Letter (PDF)
Jan 21, 2021	SUPPL -129	View Letter (PDF)
Mar 6, 2014	SUPPL -128	View Letter (PDF)
Jul 22, 2013	SUPPL -126	View Letter (PDF)
Dec 18, 2012	SUPPL -125	View Letter (PDF)
May 27, 2004	SUPPL -120	View Letter (PDF)
May 27, 2004	SUPPL -115	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 500MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 500MG

RLDAB

0 patents0 exclusivities▾

TABLET, DELAYED RELEASE;ORAL | Approved: Apr 6, 1983