Ifosfamide - Generic Drug Details

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What are the generic drug sources for ifosfamide and what is the scope of patent protection?

Ifosfamide is the generic ingredient in four branded drugs marketed by Baxter Hlthcare, Fresenius Kabi Usa, Hikma, Meitheal, Mylan Labs Ltd, and Teva Pharms Usa, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for ifosfamide. Five suppliers are listed for this compound.

Summary for ifosfamide

US Patents:	0
Tradenames:	4
Applicants:	6
NDAs:	7
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	130
Clinical Trials:	454
Patent Applications:	4,836
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for ifosfamide
What excipients (inactive ingredients) are in ifosfamide?	ifosfamide excipients list
DailyMed Link:	ifosfamide at DailyMed

See drug prices for ifosfamide

Recent Clinical Trials for ifosfamide

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Federal Research Institute of Pediatric Hematology, Oncology and Immunology	Phase 3
Washington University School of Medicine	Phase 1/Phase 2
Polaris Group	Phase 1/Phase 2

See all ifosfamide clinical trials

Pharmacology for ifosfamide

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Medical Subject Heading (MeSH) Categories for ifosfamide

Antineoplastic Agents, Alkylating

Anatomical Therapeutic Chemical (ATC) Classes for ifosfamide

L01AA	Nitrogen mustard analogues
L01A	ALKYLATING AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for ifosfamide

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Baxter Hlthcare	IFEX	ifosfamide	INJECTABLE;INJECTION	019763-002	Dec 30, 1988	AP	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan Labs Ltd	IFOSFAMIDE	ifosfamide	INJECTABLE;INJECTION	201689-001	Nov 26, 2012		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	IFOSFAMIDE	ifosfamide	INJECTABLE;INJECTION	076619-001	Jun 29, 2011	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Fresenius Kabi Usa	IFOSFAMIDE	ifosfamide	INJECTABLE;INJECTION	076078-002	May 28, 2002	AP	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for ifosfamide

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Baxter Hlthcare	IFEX	ifosfamide	INJECTABLE;INJECTION	019763-001	Dec 30, 1988	⤷ Sign Up	⤷ Sign Up
Baxter Hlthcare	IFEX	ifosfamide	INJECTABLE;INJECTION	019763-002	Dec 30, 1988	⤷ Sign Up	⤷ Sign Up
Baxter Hlthcare	IFEX	ifosfamide	INJECTABLE;INJECTION	019763-002	Dec 30, 1988	⤷ Sign Up	⤷ Sign Up
Baxter Hlthcare	IFEX	ifosfamide	INJECTABLE;INJECTION	019763-001	Dec 30, 1988	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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