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DESFERAL

NDA

DEFEROXAMINE MESYLATE | N016267 | MITEM PHARMA INC

2 strengths0 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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Desferal Mesylate (2023)

Total Spending

$39K

Total Claims

Beneficiaries

—

Avg Cost/Unit

$36.44

Spending Trend

$19K(2021)→$23K(2022)→$39K(2023)

YoY Change:+5.2%

5yr CAGR:+3.3%

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

API Supply Chain3 active DMFs4 inactive

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

TEVA PHARMACEUTICAL INDUSTRIES LTDDEFEROXAMINE MESYLATE

DMF 122411996

EXCELLA GMBH AND CO KGDEFEROXAMINE MESYLATE

DMF 184592005

EXCELLA GMBH AND CO KGDEFEROXAMINE MESYLATE USP

DMF 254212012

PHARMACIA AND UPJOHNInactiveDEFEROXAMINE MESYLATE

DMF 100411993

MYTHEN SPAInactiveDEFEROXAMINE MESYLATE

DMF 166532003

MYTHEN SPAInactiveDEFEROXAMINE MESYLATE NT

DMF 190522005

NAVINTA LLCInactiveDEFEROXAMINE MESYLATE USP

DMF 202532007

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Sep 12, 2022	SUPPL -62	View Letter (PDF)
Dec 21, 2011	SUPPL -50	View Letter (PDF)
Sep 9, 2010	SUPPL -47	View Letter (PDF)
Jan 30, 2009	SUPPL -45	View Letter (PDF)
Jan 25, 2007	SUPPL -44	View Letter (PDF)
Feb 14, 2002	SUPPL -39	View Letter (PDF)
Apr 9, 2001	SUPPL -34	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 500MG/VIAL

RLDAP

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: May 25, 2000