Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2018-00421	9693978	IPR	Catalent Pharma Solutions, Inc.	Institution Denied	2018-01-14	—
IPR2018-00422	9693979	IPR	Catalent Pharma Solutions, Inc.	Institution Denied	2018-01-14	—

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

3 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
PATHEON SOFTGELS INC. et al v. OHM LABORATORIES INC. 3:2018cv00486 1 patentANDA 202807Naproxen Sodium	D.N.J.	2018-01-12	Terminated 2018-05-18	—
Patheon Softgels Inc. et al v. Apotex Inc. et al 1:2018cv00003 2 patentsANDA 210325Naproxen Sodium	D. Del.	2018-01-02	Terminated 2018-03-20	—
PATHEON SOFTGELS INC. et al v. APOTEX INC. et al 3:2017cv13819 2 patentsANDA 210325Naproxen Sodium	D.N.J.	2017-12-29	Terminated 2019-06-04	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

226 trials from ClinicalTrials.gov, 190 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Evaluation of Rebamipide and Rabeprazole Effect Associated or Not to Prevent Naproxen-induced Gastric Lesions NCT03658473	Phase 3	Completed	Galeno Desenvolvimento de Pesquisas Clínicas	32	2014-11-12 → 2015-02-04
Mechanistic Characterization of Uterine Pain NCT04145518	Phase 4	Completed	Endeavor Health	183	2019-10-25 → 2025-07-23
Comparison of Different Analgesia Drug Regimens for Pain Control During ESWL for Renal Stones NCT02786446	N/A	Completed	Shifa International Hospital	135	2015-07 → 2016-01
Naproxen Sodium Extended-Release Actual Use Study NCT00751400	Phase 3	Completed	Bayer	497	2008-07 → 2008-11
Efficacy of Flavocoxid 500 mg Compared With Naproxen 500 mg in Subjects With Moderate-severe Osteoarthritis of the Knee NCT00790985	N/A	Completed	Primus Pharmaceuticals	223	2008-01 → 2008-08
A Study Of The Effect Of CJ-023,423 On The Incidence Of Stomach Ulcers NCT00392080	Phase 1	Completed	Pfizer	340	2006-11 → 2008-02
Efficacy and Safety of Valdecoxib and Naproxen in Treating the Signs and Symptoms of Rheumatoid Arthritis (RA) in a Severe Rheumatoid Arthritis Patients NCT00650455	Phase 4	Completed	Pfizer	489	2003-02 → 2005-01
Bioequivalence Study of Naproxen Sodium 550 mg Tablets Under Fasting Condition NCT01052129	Phase 1	Completed	Dr. Reddy's Laboratories Limited	26	2006-05 → 2006-05
Evaluate Analgesic / Sedative Efficacy of Naproxen Sodium and Diphenhydramine in Patients With Postsurgical Dental Pain NCT01495858	Phase 3	Completed	Bayer	267	2011-12 → 2012-02
Treatment of Early Phase Achilles Tendinopathy - the Effect of NSAIDs NCT03401177	N/A	Completed	Bispebjerg Hospital	70	2018-01-15 → 2020-04-27

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$0.1489

per ea

Lowest NADAC/Unit

$0.1489

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
46122078064GNP NAPROXEN SODIUM 220 MG CAP	$0.1489	EA	Generic	—	2026-06-17

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

API Supply Chain9 active DMFs14 inactive

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

DR REDDYS LABORATORIES LTDNAPROXEN SODIUM

DMF 32081978

TAPI NL BVNAPROXEN SODIUM

DMF 87461990

DR REDDYS LABORATORIES LTDNAPROXEN SODIUM

DMF 123421997

ZHEJIANG CHARIOTEER PHARMACEUTICAL CO LTDNAPROXEN SODIUM, USP (BULK)

DMF 132431998

DIVIS LABORATORIES LTDNAPROXEN SODIUM USP

DMF 138671998

APITORIA PHARMA PRIVATE LTDNAPROXEN SODIUM USP NON STERILE DRUG SUBSTANCE

DMF 228322009

ZHEJIANG CHARIOTEER PHARMACEUTICAL CO LTDNAPROXEN SODIUM GRANULE

DMF 264022012

SOLARA ACTIVE PHARMA SCIENCES LTDNAPROXEN SODIUM USP

DMF 375262022

HETERO LABS LTDNAPROXEN SODIUM

DMF 382162023

DINAMITE DIPHARMA SPAInactiveNAPROXEN SODIUM

DMF 54781984

CAMBREX PROFARMACO MILANO SRLInactiveNAPROXEN SODIUM

DMF 67121986

NOBEL CHEMICALS AB DIV FINE CHEMICALS INCInactiveNAPROXEN SODIUM USP

DMF 71311987

ZAMBON SPAInactiveNAPROXEN SODIUM

DMF 74561988

RALLIS INDIA LTDInactiveNAPROXEN SODIUM

DMF 75691988

ALFA WASSERMANN SPAInactiveNAPROXEN SODIUM

DMF 84361990

FARCHEMIA SRLInactiveNAPROXEN SODIUM USP

DMF 116271996

ALBEMARLE CORPInactiveNAPROXEN SODIUM

DMF 119401996

VERA LABORATORIES LTDInactiveNAPROXEN SODIUM

DMF 125591997

NATCO PHARMA LTDInactiveNAPROXEN SODIUM, USP

DMF 128921998

SOLARA ACTIVE PHARMA SCIENCES LTDInactiveNAPROXEN SODIUM USP

DMF 141851999

MYLAN LABORATORIES LTDInactiveNAPROXEN SODIUM USP

DMF 157322001

VERA LABORATORIES LTDInactiveNAPROXEN SODIUM

DMF 162002002

GRANULES INDIA LTDInactiveNAPROXEN SODIUM, USP

DMF 346912020

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

Approval Letters

16 letters from Drugs@FDA

Date	Submission	Document
Jan 20, 2026	SUPPL -41	View Letter (PDF)
Dec 16, 2021	SUPPL -36	View Letter (PDF)
Dec 15, 2020	SUPPL -33	View Letter (PDF)
May 1, 2020	SUPPL -28	View Letter (PDF)
Feb 28, 2020	SUPPL -27	View Letter (PDF)
Dec 11, 2019	SUPPL -26	View Letter (PDF)
Oct 29, 2019	SUPPL -25	View Letter (PDF)
Feb 22, 2019	SUPPL -23	View Letter (PDF)
Dec 20, 2018	SUPPL -22	View Letter (PDF)
Mar 20, 2017	SUPPL -19	View Letter (PDF)
Apr 3, 2013	SUPPL -18	View Letter (PDF)
Jun 15, 2012	SUPPL -17	View Letter (PDF)
Aug 16, 2010	SUPPL -13	View Letter (PDF)
Jul 17, 2009	SUPPL -11	View Letter (PDF)
Apr 21, 2009	SUPPL -10	View Letter (PDF)
Mar 1, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 200MG BASE

RLD

5 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Feb 17, 2006

Patents (5) · 6 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9693978	Mar 3, 2026	—	—	Yes	—	—
9693979	Mar 3, 2026	—	—	Yes	—	—
10022344	Mar 3, 2026	—	—	Yes		—
10028925	Mar 3, 2026	—	—	Yes		—
11090280	Mar 3, 2026	—	—	Yes		—