Viewing data from:

FELDENE

NDA

PIROXICAM | N018147 | PFIZER LABORATORIES DIV PFIZER INC

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

4 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Strides Pharma Inc. FDA-2024-P-4970 · 8 docket documents Strides Pharma Inc. filed this petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. § 314.93 requesting that the FDA declare Piroxicam Capsules, 15 mg suitable for submission in an Abbreviated New Drug Application, with the reference listed drug being F	Suitability	2024-10-25	Denied	Strides Pharma Inc.
Suitability Petition from Pharmobedient Consulting, LLC FDA-2024-P-4646 · 8 docket documents Pharmobedient Consulting, LLC filed this suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. § 314.93 requesting that the FDA declare Piroxicam Capsules 5 mg suitable for submission in an Abbreviated New Drug Application, with the reference liste	Suitability	2024-10-03	Denied	Pharmobedient Consulting, LLC
Suitability Petition from Pharmobedient Consulting, LLC FDA-2024-P-4645 · 8 docket documents Pharmobedient Consulting, LLC filed this 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 for Piroxicam Orally Disintegrating Tablets in 10 mg and 20 mg strengths, a different dosage form	Suitability	2024-10-03	Denied	Pharmobedient Consulting, LLC
Mutual Pharmaceutical Company, Inc. - Citizen Petition FDA-2013-P-0666 · 3 docket documents Mutual Pharmaceutical Company, Inc. filed this citizen petition under Section 505(j)(2)(C) requesting permission to file an ANDA for Piroxicam Capsules 5mg, a lower-strength version of its already-approved 10mg and 20mg piroxicam capsules (ANDA 73-536), with a bioequivalence waiver based on dose pro	Other	2013-06-17	Withdrawn	—

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

Clinical Trials

19 trials from ClinicalTrials.gov, 13 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Interaction Between Antihypertensives and Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)NCT00631514	Phase 4	Completed	University of Split	88	2005-01 → 2006-09
Piroxicam-beta-Cyclodextrin on Tooth Sensitivity Caused by In-office Bleaching NCT03153657	Phase 3	Completed	Universidade Federal de Sergipe	50	2016-12-13 → 2017-05
A Comparison of Analgesic İmpacts of Piroxicam and Diclofenac Sodium in the Treatment of Primary Dysmenorrhea NCT02253446	Phase 4	Completed	Pamukkale University	400	2013-05 → 2014-07
Comparative Study of Olive Oil With Piroxicam Gel in Osteoarthritis of the Knee NCT00670475	Phase 2	Completed	Ardabil University of Medical Sciences	60	2008-04 → 2010-04
Multi-Centre European Photopatch Test Study NCT00530387	N/A	Completed	NHS Tayside	1,000	2008-07 → 2011-07
Influence of Genotype of CYP2C9 on Clinical Efficacy and Pharmacokinetics of Piroxicam After Lower Third Molar Surgery NCT02450487	Phase 4	Completed	University of Sao Paulo	105	2012-10 → 2015-12
Piroxicam and Levonorgestrel Co-treatment for Emergency Contraception NCT03614494	Phase 2/3	Completed	Dr. Hang Wun Raymond Li	860	2018-08-20 → 2022-10-05
NSAIDs Versus Paracetamol Versus Paracetamol + NSAIDs in Traumatic Pain Management NCT03222518	Phase 3	Completed	University of Monastir	1,500	2017-03-01 → 2018-11-01
A Double Blind, Double Dummy, Randomized, Comparative Study Of The Efficacy And Safety Of Valdecoxib 40 Mg Twice Daily, As Needed In The First Menstrual Cycle Day And Then Once A Day, And Piroxicam 40 Mg Once A Day In The Treatment Of Patients With Primary Dysmenorrhea NCT00649415	Phase 4	Completed	Pfizer	154	2003-01 → 2003-07
Effect of Piroxicam on Ovulation NCT01320709	Phase 2	Completed	Bayer	72	2011-03 → 2012-05

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

Medicare Part D Spending

CMS annual spending data across 2 drug listings matched to this application (2024)

Piroxicam (2024)

Total Spending

$5.6M

Total Claims

53,621

Beneficiaries

18,071

Avg Cost/Unit

$0.96

YoY Change:-34.1%

5yr CAGR:-9.5%

Feldene (2023)

Total Spending

$29K

Total Claims

Beneficiaries

—

Avg Cost/Unit

$14.03

Spending Trend

$82K(2019)→$74K(2020)→$51K(2021)→$45K(2022)→$29K(2023)

YoY Change:+10.2%

5yr CAGR:+4.9%

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

API Supply Chain5 active DMFs12 inactive

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

DIPHARMA FRANCIS SRLPIROXICAM

DMF 74721988

ARCH PHARMALABS LTDPIROXICAM USP

DMF 91181991

OLON SPAPIROXICAM

DMF 269612013

UNICHEM LABORATORIES LTDPIROXICAM USP

DMF 280602014

APEX HEALTHCARE LTDPIROXICAM USP

DMF 368412022

FABBRICA ITALIANA SINTETICI SPAInactivePIROXICAM

DMF 71301987

WOCKHARDT LTDInactivePIROXICAM

DMF 74471988

MOEHS SA DIV SANOFInactivePIROXICAM

DMF 74731988

EGIS PHARMACEUTICALS PRIVATE LTDInactivePIROXICAM

DMF 75851988

SIBEFAT SPAInactivePIROXICAM

DMF 76601988

ESTEVE QUIMICA SAInactivePIROXICAM

DMF 76971988

KRKA PHARMACEUTICAL AND CHEMICAL WORKSInactivePIROXICAM

DMF 80551989

NANTONG PHARMACEUTICAL FACTORYInactivePIROXICAM

DMF 81841989

MEDICHEM SAInactivePIROXICAM

DMF 82311989

SUMIKA FINE CHEMICALS CO LTDInactivePIROXICAM

DMF 83531989

CHEMICAL PHARMACEUTICAL RESEARCH INSTITUTE NIHFI LTDInactivePIROXICAM

DMF 106951993

RAMDEV CHEMICAL PVT LTDInactivePIROXICAM USP

DMF 319012017

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

Approval Letters

13 letters from Drugs@FDA

Date	Submission	Document
Nov 22, 2024	SUPPL -53	View Letter (PDF)
Apr 29, 2021	SUPPL -50	View Letter (PDF)
May 6, 2019	SUPPL -48	View Letter (PDF)
May 11, 2016	SUPPL -44	View Letter (PDF)
Mar 2, 2015	SUPPL -40	View Letter (PDF)
Mar 2, 2015	SUPPL -38	View Letter (PDF)
Mar 2, 2015	SUPPL -39	View Letter (PDF)
Mar 2, 2015	SUPPL -42	View Letter (PDF)
Mar 2, 2015	SUPPL -33	View Letter (PDF)
Sep 7, 2010	SUPPL -32	View Letter (PDF)
Jul 10, 2007	SUPPL -30	View Letter (PDF)
Jan 30, 2006	SUPPL -29	View Letter (PDF)
Jun 4, 2004	SUPPL -28	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#002 — 10MG

RLDAB

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Apr 6, 1982

No patent or exclusivity listings for this strength.

#003 — 20MG

RLDAB

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Apr 6, 1982