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IFEX

NDA

IFOSFAMIDE | N019763 | BAXTER HEALTHCARE CORP

4 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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Gensia Sicor Pharmaceuticals, Inc. FDA-1999-P-0165 Gensia Sicor Pharmaceuticals, Inc. filed this ANDA suitability petition under Section 505(j)(2)(c) requesting permission to submit an abbreviated new drug application for Ifosfamide Injection 50 mg/ml in ready-to-use liquid form in 1 g and 3 g single-use vials, with Ifex (ifosfamide powder for injec	Other	2017-05-09	Withdrawn	Gensia Sicor Pharmaceuticals

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part B Spending

CMS physician-administered drug spending for Ifex (2023)

Total Spending

$59K

Total Claims

604

Beneficiaries

ASP Price

—

HCPCS: J9208 — Injection, ifosfamide, 1 gram

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

API Supply Chain4 active DMFs1 inactive

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

BAXTER HEALTHCARE CORPIFOSFAMIDE USP/EP

DMF 35061979

JIANGSU HENGRUI PHARMACEUTICALS CO LTDIFOSFAMIDE USP, NON-STERILE, BULK DRUG SUBSTANCE

DMF 112901995

IFOTAM CO LTDIFOSFAMIDE

DMF 150642000

AARTI PHARMALABS LTDIFOSFAMIDE

DMF 250812009

DEGUSSA HULS AGInactiveIFOSFAMIDE CRUDE

DMF 147962000

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Dec 3, 2024	SUPPL -21	View Letter (PDF)
Aug 3, 2018	SUPPL -20	View Letter (PDF)
Sep 2, 2014	SUPPL -19	View Letter (PDF)
Mar 5, 2012	SUPPL -17	View Letter (PDF)
Mar 25, 2011	SUPPL -16	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLDAP

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Dec 30, 1988

No patent or exclusivity listings for this strength.

#002 — 3GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLDAP

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Dec 30, 1988

#003 — 1GM/VIAL;100MG/ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Oct 10, 1992

#004 — 3GM/VIAL;100MG/ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Oct 10, 1992