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DAYPRO

NDA

OXAPROZIN | N018841 | PFIZER INC

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

2 petitions (2 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Pharmobedient Consulting, LLC FDA-2023-P-4290 Pharmobedient Consulting, LLC filed 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 for Oxaprozin Tablets in 300 mg and 1200 mg strengths, which differ from the Reference Listed Drug D	Suitability	2023-10-03	Open	Pharmobedient Consulting
Attachment 4 Draft Guidance Oxaprozin re Suitability Petition from Pharmobedi... FDA-2023-P-4290 Pharmobedient Consulting LLC filed a suitability petition regarding oxaprozin, requesting FDA guidance on the suitability of the drug substance for use in pharmaceutical formulations and requesting that the agency issue a determination regarding the appropriate regulatory pathway and standards for o	Suitability	2023-10-03	Open	Pharmobedient Consulting LLC

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 Daypro (2023)

Total Spending

$35K

Total Claims

Beneficiaries

—

Avg Cost/Unit

$8.12

Spending Trend

$134K(2019)→$135K(2020)→$124K(2021)→$38K(2022)→$35K(2023)

YoY Change:-2.3%

5yr CAGR:+1.8%

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

API Supply Chain4 active DMFs9 inactive

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

KATWIJK CHEMIE BVOXAPROZIN

DMF 113081995

OLON SPAOXAPROZIN

DMF 129111998

COSMA SPAOXAPROZIN

DMF 129991998

DR REDDYS LABORATORIES LTDOXAPROZIN USP

DMF 144281999

DSM PHARMA CHEMICALS SOUTH HAVEN INCInactiveOXAPROZIN

DMF 111561994

SUMITOMO CHEMICAL CO LTDInactiveOXAPROZIN

DMF 117481995

MEDICHEM SAInactiveOXAPROZIN

DMF 118621996

CILAG AGInactiveOXAPROZIN

DMF 118671996

CORDEN PHARMA BERGAMO SPAInactiveOXAPROZIN

DMF 123401997

CHINA CHEMICAL SYNTHESIS INDUSTRIAL CO LTDInactiveOXAPROZIN (BULK ACTIVE PHARMACEUTICAL INGREDIENT)

DMF 131191998

ZAMBON GROUP SPAInactiveOXAPROZIN

DMF 132271998

ERREGIERRE SPAInactiveOXAPROZIN JP

DMF 140591999

SOCIETA ITALIANA MEDICINALI SCANDICCIInactiveOXAPROZIN

DMF 154842001

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

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Nov 22, 2024	SUPPL -36	View Letter (PDF)
Apr 29, 2021	SUPPL -33	View Letter (PDF)
May 6, 2019	SUPPL -30	View Letter (PDF)
May 12, 2016	SUPPL -28	View Letter (PDF)
Jul 5, 2007	SUPPL -22	View Letter (PDF)
Jan 20, 2006	SUPPL -21	View Letter (PDF)
Jun 2, 2004	SUPPL -20	View Letter (PDF)
Jan 25, 2002	SUPPL -12	View Letter (PDF)
Jan 25, 2002	SUPPL -16	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#004 — 600MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Oct 29, 1992

No patent or exclusivity listings for this strength.