Viewing data from:

GRAFAPEX

NDA

TREOSULFAN | N214759 | MEDEXUS PHARMA INC

2 strengths1 unique patent3 unique exclusivities

Patent Timeline

1 unique patent, 3 exclusivities by expiration date

Expiring < 1yr (1)TodayExclusivity

2027

2028

2029

2030

2031

2032

Today

7199162

Oct. 12, 2026

NCE

Jan. 21, 2030

ODE-513

Jan. 21, 2032

ODE-514

Jan. 21, 2032

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

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain2 active DMFs

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

MEDAC GESELLSCHAFT FUR KLINISCHE SPEZIALPRAPARATE MBHTREOSULFAN

DMF 129141998

FERMION OYTREOSULFAN

DMF 345702020

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Feb 6, 2025	SUPPL -1	View Letter (PDF)
Feb 4, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 1GM/VIAL

RLD

1 patent3 exclusivities▴

POWDER;INTRAVENOUS | Approved: Jan 21, 2025

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7199162	Oct 12, 2026	—	—	—		—

Exclusivities (3)

Code	Date	Status
NCE	Jan 21, 2030	Active
ODE-513	Jan 21, 2032	Active
ODE-514	Jan 21, 2032	Active

#002 — 5GM/VIAL

RLD

1 patent3 exclusivities▾

POWDER;INTRAVENOUS | Approved: Jan 21, 2025