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ALEVE

NDA

NAPROXEN SODIUM | N020204 | BAYER HEALTHCARE LLC

1 strength0 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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Elan Pharmaceuticals FDA-1998-P-0829 · 9 docket documents Elan Pharmaceuticals filed this citizen petition under section 505(j) of the Federal Food, Drug, and Cosmetic Act on December 15, 1998, requesting that the FDA require abbreviated new drug applications (ANDAs) for controlled release naproxen sodium products referencing Naprelan include additional ph	505(q)	2016-12-01	Denied	Elan Pharmaceuticals

Source: Regulations.gov. FDA citizen petitions matched by application number.

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.

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

47 letters from Drugs@FDA

Date	Submission	Document
Mar 12, 2026	SUPPL -90	View Letter (PDF)
May 1, 2025	SUPPL -89	View Letter (PDF)
May 1, 2025	SUPPL -89	View Letter (PDF)
Sep 16, 2024	SUPPL -88	View Letter (PDF)
Jun 13, 2023	SUPPL -84	View Letter (PDF)
Mar 11, 2022	SUPPL -83	View Letter (PDF)
Apr 5, 2021	SUPPL -81	View Letter (PDF)
Jan 4, 2021	SUPPL -77	View Letter (PDF)
Jan 4, 2021	SUPPL -80	View Letter (PDF)
Jan 4, 2021	SUPPL -79	View Letter (PDF)
Jan 4, 2021	SUPPL -78	View Letter (PDF)
Nov 2, 2020	SUPPL -76	View Letter (PDF)
May 11, 2020	SUPPL -72	View Letter (PDF)
Apr 24, 2020	SUPPL -71	View Letter (PDF)
Mar 4, 2020	SUPPL -70	View Letter (PDF)
Aug 13, 2019	SUPPL -68	View Letter (PDF)
Jul 24, 2019	SUPPL -67	View Letter (PDF)
Jul 5, 2019	SUPPL -66	View Letter (PDF)
May 15, 2019	SUPPL -63	View Letter (PDF)
May 15, 2019	SUPPL -64	View Letter (PDF)
Feb 13, 2019	SUPPL -61	View Letter (PDF)
Jan 4, 2019	SUPPL -62	View Letter (PDF)
Oct 1, 2018	SUPPL -59	View Letter (PDF)
Aug 30, 2018	SUPPL -58	View Letter (PDF)
Jul 26, 2018	SUPPL -57	View Letter (PDF)
Jun 14, 2018	SUPPL -56	View Letter (PDF)
Jun 14, 2018	SUPPL -55	View Letter (PDF)
Apr 1, 2018	SUPPL -54	View Letter (PDF)
Mar 29, 2018	SUPPL -53	View Letter (PDF)
Sep 19, 2017	SUPPL -52	View Letter (PDF)
Aug 25, 2017	SUPPL -51	View Letter (PDF)
Apr 23, 2013	SUPPL -44	View Letter (PDF)
Feb 8, 2013	SUPPL -38	View Letter (PDF)
Jan 7, 2013	SUPPL -42	View Letter (PDF)
Mar 19, 2012	SUPPL -40	View Letter (PDF)
Mar 19, 2012	SUPPL -39	View Letter (PDF)
Apr 11, 2011	SUPPL -37	View Letter (PDF)
Feb 24, 2011	SUPPL -36	View Letter (PDF)
Nov 8, 2010	SUPPL -35	View Letter (PDF)
Apr 21, 2009	SUPPL -32	View Letter (PDF)
Nov 26, 2008	SUPPL -31	View Letter (PDF)
Jan 20, 2006	SUPPL -23	View Letter (PDF)
May 5, 2005	SUPPL -21	View Letter (PDF)
Mar 24, 2004	SUPPL -19	View Letter (PDF)
Aug 30, 2002	SUPPL -16	View Letter (PDF)
Mar 19, 2002	SUPPL -8	View Letter (PDF)
Mar 6, 2001	SUPPL -7	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#002 — 220MG

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jan 11, 1994

No patent or exclusivity listings for this strength.