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ORNIDYL

NDA

EFLORNITHINE HYDROCHLORIDE | N019879 | SANOFI AVENTIS US 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
TArgeting Type 1 Diabetes Using POLyamines (TADPOL)NCT05594563	Phase 2	Active	Emily K. Sims	81	2023-03-14 → 2028-05
Retifanlimab With or Without Difluoromethylornithine for the Treatment of Progressive High Grade Gliomas NCT07468136	Phase 1/2	Recruiting	Mayo Clinic	33	2026-06-23 → 2030-10-25
Eflornithine (DFMO) and AMXT 1501 for Neuroblastoma, CNS Tumors, and Sarcomas NCT06465199	Phase 1/2	Recruiting	Milton S. Hershey Medical Center	289	2026-05-13 → 2035-05

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

API Supply Chain2 active DMFs

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

SCINOPHARM TAIWAN LTDEFLORNITHINE HYDROCHLORIDE

DMF 185092005

RUSAN PHARMA LTDEFLORNITHINE HYDROCHLORIDE MONOHYDRATE

DMF 317802017

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

Products (1)

#002 — 200MG/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Nov 28, 1990

No patent or exclusivity listings for this strength.