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ANSAID

NDA

FLURBIPROFEN | N018766 | PHARMACIA AND UPJOHN CO

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

3 petitions (3 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Premier Research International, LLC FDA-2026-P-3166 · 2 docket documents Premier Research International, LLC filed this citizen petition requesting that the FDA determine the discontinuation of Flurbiprofen Oral Tablet 100 mg and 50 mg under NDA 018766 from Pharmacia and Upjohn Co was not due to safety or efficacy reasons, to enable Premier's client to submit a 505(b)(2)	505(q)	2026-03-26	Open	Premier Research International, LLC
Suitability Petition from Senores Pharmaceuticals, Inc. FDA-2025-P-5490 · 8 docket documents Senores Pharmaceuticals, Inc. filed this suitability petition pursuant to section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to submit an Abbreviated New Drug Application for Flurbiprofen Tablets 25 mg, a new strength differing from the Reference Listed Drug ANS	Suitability	2025-10-20	Open	Senores Pharmaceuticals, Inc.
Suitability Petition from Senores Pharmaceuticals, Inc. FDA-2025-P-1277 · 8 docket documents Senores Pharmaceuticals, Inc. submitted a suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to submit an Abbreviated New Drug Application (ANDA) for Flurbiprofen Tablets 75 mg, a new strength that differs from the Reference Listed Dru	Suitability	2025-05-16	Open	Senores Pharmaceuticals, Inc.

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

Clinical Trials

42 trials from ClinicalTrials.gov — 1 recruiting, 33 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Determinants of Warfarin Metabolism NCT00162474	N/A	Recruiting	Hadassah Medical Organization	1,000	2003-09 → 2030-12
Effect of GSK376501 on CYP450 Activity in Healthy Adult Subjects NCT00615212	Phase 1	Completed	GlaxoSmithKline	23	2008-01-02 → 2008-02-15
Combination of Remifentanil and Flurbiprofen in Sedation and Analgesia for ESWL of Pancreatic Stone NCT01998217	Phase 4	Completed	Changhai Hospital	60	2012-09 → 2013-12
The Safety and Efficacy of 5% Lidocaine Patch and Flurbiprofen Patch for Relieving Acute Low Back Pain NCT03171987	Phase 4	Completed	Taipei Medical University Hospital	85	2017-06-14 → 2021-06-30
Flurbiprofen Axetil for Uterine Contraction Pain NCT00725218	Phase 4	Completed	Nanjing Medical University	97	2008-05 → 2008-08
Evaluation of the Potential Pharmacokinetic Interactions Between Probe Drugs in the Geneva Phenotyping Cocktail NCT02391688	Phase 1	Completed	Jules Desmeules	30	2014-11 → 2015-04
Local Flurbiprofen to Treat Pain Following Wisdom Tooth Extraction NCT00001724	Phase 2	Completed	National Institute of Dental and Craniofacial Research (NIDCR)	100	1997-11 → 2001-11
Effect of Butorphanol Combined With Flurbiprofen Axetil on Preventing Hyperalgesia Induced by Remifentanil in Patients NCT02043366	N/A	Completed	Tianjin Medical University General Hospital	180	2014-02 → 2015-08
Study to Investigate the Effect of BMS-986142 on the Pharmacokinetics (PK) of Methotrexate and Probe Substrate Cocktail in Healthy Patients NCT02456844	Phase 1	Completed	Bristol-Myers Squibb	24	2015-05 → 2015-07
Nalbuphine and Flurbiprofen for Oculoplastic Surgery NCT03422887	N/A	Completed	Sun Yat-sen University	330	2018-01-18 → 2018-09-30

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

Medicare Part D Spending

CMS annual spending data for Flurbiprofen (2024)

Total Spending

$631K

Total Claims

16,235

Beneficiaries

6,802

Avg Cost/Unit

$0.53

Spending Trend

$717K(2019)→$875K(2020)→$771K(2021)→$679K(2022)→$861K(2023)→$631K(2024)

YoY Change:-20.3%

5yr CAGR:+0.5%

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

API Supply Chain5 active DMFs6 inactive

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

PHARMARON MANUFACTURING SERVICES UK LTDFLURBIPROFEN

DMF 24351975

FDC LTDFLURBIPROFEN USP

DMF 82191989

WR GRACE AND COFLURBIPROFEN USP & BP

DMF 119021996

RA CHEM PHARMA LTDFLURBIPROFEN USP

DMF 339952019

SUZHOU RYWAY BIOTECH CO LTDFLURBIPROFEN

DMF 410682024

KV PHARMACEUTICAL COInactiveFLURBIPROFEN 200MG CAPS

DMF 47601982

FOREST LABORATORIES INCInactiveFLURBIPROFEN 100 MG C.R.TABS (IN SYNCHRON VEHICLE

DMF 51851983

FOREST LABORATORIES INCInactiveFLURBIPROFEN 200 mg C.R. TABS (IN SYNCHRON VEHICLE

DMF 51921983

ERREGIERRE SPAInactiveFLURBIPROFEN

DMF 96411992

WYCKOFF CHEMICAL CO INCInactiveFLURBIPROFEN

DMF 98401992

VASUDHA PHARMA CHEM LTDInactiveFLURBIPROFEN USP

DMF 328762018

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
May 11, 2016	SUPPL -20	View Letter (PDF)
Sep 7, 2010	SUPPL -15	View Letter (PDF)
Jul 5, 2007	SUPPL -14	View Letter (PDF)
Jan 30, 2006	SUPPL -13	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#002 — 50MG

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Oct 31, 1988

No patent or exclusivity listings for this strength.

#003 — 100MG

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 31, 1988