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NDA

TRIFLURIDINE | N018299 | MONARCH PHARMACEUTICALS 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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

3 trials from ClinicalTrials.gov — 2 recruiting, 1 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Trial to Find Out How Safe REGN7075 is and How Well it Works in Combination With Cemiplimab for Adult Participants With Advanced Cancers NCT04626635	Phase 1/2	Active	Regeneron Pharmaceuticals	548	2020-12-21 → 2027-03-05
A Study to Access Intravenous (IV) Telisotuzumab Adizutecan in Combination With IV Bevacizumab Compared to Standard of Care IV Bevacizumabin Combination With Oral Trifluridine and Tipiracil in Adult Participants With Refractory Metastatic Colorectal Cancer NCT07525206	Phase 3	Recruiting	AbbVie	700	2026-05-22 → 2030-03
Study of Denikitug (GS-1811) Given Alone or With Nivolumab or With Chemotherapy in Adults With Advanced Colorectal Cancer NCT07527858	Phase 2	Recruiting	Gilead Sciences	170	2026-05-19 → 2028-12

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

API Supply Chain7 active DMFs

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

YUKI GOSEI KOGYO CO LTDTRIFLURIDINE

DMF 284792014

BIOPHORE INDIA PHARMACEUTICALS PVT LTDTRIFLURIDINE

DMF 330652018

MSN LABORATORIES PRIVATE LTDTRIFLURIDINE USP

DMF 335732019

INTAS PHARMACEUTICALS LTDTRIFLURIDINE USP

DMF 336152019

APITORIA PHARMA PRIVATE LTDTRIFLURIDINE USP

DMF 338802019

NATCO PHARMA LTDTRIFLURIDINE

DMF 339252019

TAIHO PHARMACEUTICAL CO LTDTRIFLURIDINE DRUG SUBSTANCE

DMF 345962020

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Feb 20, 2002	SUPPL -14	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1%

RLDAT

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.