Last Updated: September 24, 2026

Details for New Drug Application (NDA): 205580

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NDA 205580 describes BELRAPZO, which is a drug marketed by Eagle Pharms and is included in one NDA. It is available from one supplier. There are eleven patents protecting this drug. Additional details are available on the BELRAPZO profile page.

The generic ingredient in BELRAPZO is bendamustine hydrochloride. There is one drug master file entry for this compound. Twelve suppliers are listed for this compound. Additional details are available on the bendamustine hydrochloride profile page.

Summary for 205580

Tradename:	BELRAPZO
Applicant:	Eagle Pharms
Ingredient:	bendamustine hydrochloride
Patents:	11

Pharmacology for NDA: 205580

Mechanism of Action	Alkylating Activity

Medical Subject Heading (MeSH) Categories for 205580

Antineoplastic Agents, Alkylating

Suppliers and Packaging for NDA: 205580

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BELRAPZO	bendamustine hydrochloride	SOLUTION;INTRAVENOUS	205580	NDA	Eagle Pharmaceuticals, Inc	42367-521	42367-521-25	1 VIAL, MULTI-DOSE in 1 CARTON (42367-521-25) / 4 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	100MG/4ML (25MG/ML)
Approval Date:	May 15, 2018	TE:	AP	RLD:	Yes
Patent:	10,010,533	Patent Expiration:	Jan 28, 2031	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	11,103,483	Patent Expiration:	Jan 28, 2031	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
Patent:	11,103,483	Patent Expiration:	Jan 28, 2031	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA

Expired US Patents for NDA 205580

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Eagle Pharms	BELRAPZO	bendamustine hydrochloride	SOLUTION;INTRAVENOUS	205580-001	May 15, 2018	8,791,270	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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