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COXANTO

NDA

OXAPROZIN | N217927 | SOLUBIOMIX LLC

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 (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Senores Pharmaceuticals, Inc. FDA-2026-P-3665 · 7 docket documents Senores Pharmaceuticals, Inc. filed this suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Oxaprozin Capsules, 600 mg suitable for submission in an Abbreviated New Drug Application, with the reference listed drug being COXANTO	Suitability	2026-04-03	Open	Senores Pharmaceuticals, Inc.
Attachment 4 Draft Guidance Oxaprozin re Suitability Petition from Pharmobedi... FDA-2023-P-4290 · 8 docket documents 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	Granted	Pharmobedient Consulting LLC

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

Clinical Trials

1 trial from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Drug-drug Interaction Study of FYU-981 and Oxaprozin NCT03350386	Phase 1	Completed	Mochida Pharmaceutical Company, Ltd.	12	2017-11-02 → 2017-12-05

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

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

2 letters from Drugs@FDA

Date	Submission	Document
Nov 25, 2024	SUPPL -2	View Letter (PDF)
Oct 24, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 300MG

RLD

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Oct 20, 2023

No patent or exclusivity listings for this strength.