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ANAPROX

NDA

NAPROXEN SODIUM | N018164 | ATNAHS PHARMA US LTD

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

1 trial from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Effect of Preoperative Tramadol and Naproxen Sodium on Post Operative Pain NCT05982392	Phase 2/3	Completed	Dow University of Health Sciences	139	2023-03-01 → 2023-08-15

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

Medicare Part D Spending

CMS annual spending data for Naproxen Sodium Cr (2023)

Total Spending

$3.1M

Total Claims

3,872

Beneficiaries

1,604

Avg Cost/Unit

$6.82

Spending Trend

$17.1M(2019)→$12.7M(2020)→$8.6M(2021)→$6.8M(2022)→$180K(2022)→$1.5M(2023)→$3.1M(2023)

YoY Change:-36.7%

5yr CAGR:-4.1%

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

API Supply Chain8 active DMFs12 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

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

SOLARA ACTIVE PHARMA SCIENCES LTDInactiveNAPROXEN SODIUM USP

DMF 141851999

MYLAN LABORATORIES LTDInactiveNAPROXEN SODIUM USP

DMF 157322001

VERA LABORATORIES LTDInactiveNAPROXEN SODIUM

DMF 162002002

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

Approval Letters

15 letters from Drugs@FDA

Date	Submission	Document
Nov 25, 2024	SUPPL -67	View Letter (PDF)
May 14, 2024	SUPPL -66	View Letter (PDF)
Apr 29, 2021	SUPPL -65	View Letter (PDF)
Jul 23, 2019	SUPPL -64	View Letter (PDF)
Mar 14, 2017	SUPPL -63	View Letter (PDF)
May 11, 2016	SUPPL -62	View Letter (PDF)
Mar 26, 2013	SUPPL -61	View Letter (PDF)
Jul 30, 2008	SUPPL -60	View Letter (PDF)
Sep 25, 2007	SUPPL -58	View Letter (PDF)
Apr 25, 2007	SUPPL -57	View Letter (PDF)
Mar 23, 2006	SUPPL -55	View Letter (PDF)
Jan 30, 2006	SUPPL -56	View Letter (PDF)
Nov 16, 2004	SUPPL -51	View Letter (PDF)
Nov 16, 2004	SUPPL -50	View Letter (PDF)
May 29, 2003	SUPPL -49	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.

#003 — EQ 500MG BASE

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 30, 1987