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RELAFEN

NDA

NABUMETONE | N019583 | SMITHKLINE BEECHAM CORP DBA GLAXOSMITHKLINE

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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Pharmobedient Consulting, LLC FDA-2025-P-0376 Pharmobedient Consulting, LLC filed this suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Nabumetone Tablets, 250 mg suitable for submission in an Abbreviated New Drug Application (ANDA), with the reference listed drug being	Suitability	2025-02-04	Open	Pharmobedient Consulting

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Relafen Ds (2023)

Total Spending

$2.1M

Total Claims

653

Beneficiaries

252

Avg Cost/Unit

$53.96

Spending Trend

$467K(2020)→$1.2M(2021)→$1.7M(2022)→$2.1M(2023)

YoY Change:+7.5%

5yr CAGR:+9.6%

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

API Supply Chain6 active DMFs14 inactive

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

DIVIS LABORATORIES LTDNABUMETONE USP

DMF 153642001

MATRIX PHARMACORP PRIVATE LTDNABUMETONE USP

DMF 182122005

SOUTHWEST SYNTHETIC PHARMACEUTICAL CORP LTDNABUMETONE USP

DMF 185812005

ERREGIERRE SPANABUMETONE USP

DMF 192432006

TAPI NL BVNABUMETONE USP

DMF 222582008

HETERO DRUGS LTDNABUMETONE

DMF 267472012

ESTEVE QUIMICA SAInactiveNABUMETONE

DMF 119841996

DINAMITE DIPHARMA SPAInactiveNABUMETONE

DMF 120911996

CHEMI SPAInactiveNABUMETONE

DMF 122961996

NAPP TECHNOLOGIES INCInactiveNABUMETONE

DMF 124451997

PHARMACEUTICAL FINE CHEMICALS PFC BAHAMAS LTDInactiveNABUMETONE

DMF 126231997

RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPAInactiveNABUMETONE

DMF 131051998

API INCInactiveNABUMETONE DRUG SUBSTANCE

DMF 141741999

ERREGIERRE SPAInactiveNABUMETONE

DMF 146001999

ZHEJIANG SHENZHOU PHARMACEUTICAL CO LTDInactiveNABUMETONE(BULK)

DMF 148042000

RECORDATI CORPInactiveNABUMETONE

DMF 154912001

IPCA LABORATORIES LTDInactiveNABUMETONE

DMF 175662004

JIANGSU ZHONGDAN PHARMACEUTICAL CO LTDInactiveNABUMETONE

DMF 189762007

IPCA LABORATORIES LTDInactiveNABUMETONE USP, PROCESS II

DMF 206202007

LUPIN LTDInactiveNABUMETONE (MICRONISED) USP

DMF 214672008

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jan 30, 2006	SUPPL -25	View Letter (PDF)
Aug 15, 2005	SUPPL -23	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Dec 24, 1991

No patent or exclusivity listings for this strength.

#002 — 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 24, 1991