BELRAPZO Drug Patent Profile

Which patents cover Belrapzo, and when can generic versions of Belrapzo launch?

Belrapzo is a drug marketed by Eagle Pharms and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-four patent family members in thirty-one countries.

The generic ingredient in BELRAPZO is bendamustine hydrochloride. There are twenty-three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the bendamustine hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Belrapzo

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 12, 2026. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

There are fourteen tentative approvals for the generic drug (bendamustine hydrochloride), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for BELRAPZO

International Patents:	64
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	4
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in BELRAPZO?	BELRAPZO excipients list
DailyMed Link:	BELRAPZO at DailyMed

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for BELRAPZO

NDA:

205580

Dosage:

SOLUTION;IV (INFUSION)

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for BELRAPZO

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

Sponsor	Phase
City of Hope Medical Center	Phase 1
National Cancer Institute (NCI)	Phase 1
National Cancer Institute (NCI)	Phase 3

See all BELRAPZO clinical trials

Pharmacology for BELRAPZO

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Anatomical Therapeutic Chemical (ATC) Classes for BELRAPZO

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

Paragraph IV (Patent) Challenges for BELRAPZO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BELRAPZO	Injection	bendamustine hydrochloride	100 mg/4 mL (25 mg/mL) multiple-dose vials	205580	1	2018-07-17

US Patents and Regulatory Information for BELRAPZO

BELRAPZO is protected by twelve US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting BELRAPZO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eagle Pharms	BELRAPZO	bendamustine hydrochloride	SOLUTION;IV (INFUSION)	205580-001	May 15, 2018		RX	Yes	Yes			Y
Eagle Pharms	BELRAPZO	bendamustine hydrochloride	SOLUTION;IV (INFUSION)	205580-001	May 15, 2018		RX	Yes	Yes
Eagle Pharms	BELRAPZO	bendamustine hydrochloride	SOLUTION;IV (INFUSION)	205580-001	May 15, 2018		RX	Yes	Yes			Y
Eagle Pharms	BELRAPZO	bendamustine hydrochloride	SOLUTION;IV (INFUSION)	205580-001	May 15, 2018		RX	Yes	Yes			Y

International Patents for BELRAPZO

When does loss-of-exclusivity occur for BELRAPZO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

Eurasian Patent Organization

European Patent Office

Hong Kong

Israel

Japan

Malaysia

Mexico

New Zealand

Norway

Singapore

South Africa

South Korea

Spain

Taiwan

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering BELRAPZO around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2528602	FORMULATIONS DE BENDAMUSTINE (FORMULATIONS OF BENDAMUSTINE)
Portugal	3158991
Japan	2008526991
Hungary	E031208