Viewing data from:

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

47 trials from ClinicalTrials.gov — 2 recruiting, 33 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response NCT03414502	Phase 3	Recruiting	University of Nebraska	400	2007-12-10 → 2029-03
Clinical Trial Evaluating Methotrexate or Leflunomide + Targeted Therapy Versus Methotrexate or Leflunomide + Sulfasalazine + Hydroxychloroquine in Patients With Rheumatoid Arthritis and Insufficient Response to Methotrexate or Leflunomide NCT02714634	Phase 4	Recruiting	University Hospital, Strasbourg, France	286	2016-03-30 → 2029-03
Triple III Comparison of Leflunomide Alone Versus Two DMARD Combinations in the Treatment of Rheumatoid Arthritis NCT00579878	Phase 3	Completed	University of Nebraska	69	2001-03-27 → 2010-03-11
IL-7 and IL-7R Expression in RA Patients With Active vs. Inactive Disease Treated With DMARD or CIMZIA NCT02451748	Phase 4	Completed	University of Illinois at Chicago	32	2015-08 → 2017-12
Oral Pharmacokinetics of Sulfasalazine, Paracetamol, Fexofenadine and Valsartan Using Different Administration Mediums NCT03012763	Phase 1	Completed	University Medicine Greifswald	9	2016-04
Pilot Study Effect of Sulfasalazine on Glutamate Levels by(Magnetic Resonance Spectroscopy)MRS in Patients With Glioma NCT01577966	N/A	Completed	University of Alabama at Birmingham	9	2012-01 → 2015-01
Methotrexate, Blood Pressure and Arterial Function in Rheumatoid Arthritis NCT03254589	Phase 4	Completed	Flinders University	124	2017-10-01 → 2023-12-31
Severe Psoriatic Arthritis - Early intervEntion to Control Disease: the SPEED Trial NCT03739853	Phase 4	Completed	University of Oxford	192	2019-05-14 → 2024-10-31
Effects of Methylnaltrexone in Comparison to Naloxone on Loperamide-induced Delay of the Oro-cecal, Whole-gut and Colon Transit Time.NCT01596764	Phase 1	Completed	University Medicine Greifswald	16	2011-05 → 2012-01
Effect of Sarilumab on Patient-reported Outcomes in Patients With Active Rheumatoid Arthritis NCT03449758	Phase 4	Completed	Sanofi	84	2018-03-05 → 2019-07-31

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 4 NDCs

Highest NADAC/Unit

$0.2840

per ea

Lowest NADAC/Unit

$0.1975

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
59762010405SULFASALAZINE DR 500 MG TAB	$0.2840	EA	Generic	—	2026-06-17
59762010406SULFASALAZINE DR 500 MG TAB	$0.2840	EA	Generic	—	2026-06-17
59762500005SULFASALAZINE 500 MG TABLET	$0.1975	EA	Generic	—	2026-06-17
59762500006SULFASALAZINE 500 MG TABLET	$0.1975	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 | 16 NDCs (8 FSS, 8 Big4)

Lowest Price

$9.65

Highest Price

$644.36

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
59762-5000-05SULFASALAZINE 500MG TAB	$17.46	FSS	Mylan Pharmaceuticals, Inc.	12/31/2027
59762-5000-05SULFASALAZINE 500MG TAB	$9.65	Big4	Mylan Pharmaceuticals, Inc.	12/31/2027
59762-5000-06SULFASALAZINE 500MG TAB	$49.09	FSS	Mylan Pharmaceuticals, Inc.	12/31/2027
59762-5000-06SULFASALAZINE 500MG TAB	$24.22	Big4	Mylan Pharmaceuticals, Inc.	12/31/2027
00013-0102-50AZULFIDINE EN-TABS	$214.78	FSS	Pfizer Inc.	06/30/2029
00013-0102-50AZULFIDINE EN-TABS	$160.19	Big4	Pfizer Inc.	06/30/2029

Showing 6 of 16 NDCs.

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

Medicare Part D Spending

CMS annual spending data for Azulfidine (2024)

Total Spending

$232K

Total Claims

532

Beneficiaries

171

Avg Cost/Unit

$1.73

Spending Trend

$368K(2019)→$387K(2020)→$580K(2021)→$433K(2022)→$272K(2023)→$232K(2024)

YoY Change:-3.6%

5yr CAGR:+1.1%

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

API Supply Chain3 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

CAMBREX CHARLES CITY INCSULFASALAZINE, PURIFIED

DMF 419262025

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