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Last Updated: June 7, 2023

BELRAPZO Drug Patent Profile


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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-three patent family members in thirty countries.

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

Summary for BELRAPZO
International Patents:63
US Patents:7
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 4
Formulation / Manufacturing:see details
Drug Prices: Drug price information for BELRAPZO
What excipients (inactive ingredients) are in BELRAPZO?BELRAPZO excipients list
DailyMed Link:BELRAPZO at DailyMed
Drug patent expirations by year for BELRAPZO
Drug Prices for BELRAPZO

See drug prices for BELRAPZO

Recent Clinical Trials for BELRAPZO

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

SponsorPhase
National Cancer Institute (NCI)Phase 1
City of Hope Medical CenterPhase 1
National Cancer Institute (NCI)Phase 3

See all BELRAPZO clinical trials

Pharmacology for BELRAPZO
Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity
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 and one FDA Regulatory Exclusivity.

Patents protecting BELRAPZO

Formulations of bendamustine
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Formulations of bendamustine
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA

Formulations of bendamustine
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA

Formulations of bendamustine
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA

Formulations of bendamustine
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA

Bendamustine pharmaceutical compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA

Bendamustine pharmaceutical compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA

Formulations of bendamustine
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Formulations of bendamustine
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA

Formulations of bendamustine
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA

Formulations of bendamustine
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA

Formulations of bendamustine
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA

FDA Regulatory Exclusivity protecting BELRAPZO

FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
Exclusivity Expiration: ⤷  Try a Trial

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

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

Patent: 2877
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 06204817
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0606332
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 93582
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1119708
Estimated Expiration: ⤷  Try a Trial

Patent: 2078305
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 3324
Estimated Expiration: ⤷  Try a Trial

Patent: 0701511
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 63452
Estimated Expiration: ⤷  Try a Trial

Patent: 74334
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 16073
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 88195
Estimated Expiration: ⤷  Try a Trial

Patent: 26833
Estimated Expiration: ⤷  Try a Trial

Patent: 08526991
Estimated Expiration: ⤷  Try a Trial

Patent: 13056901
Estimated Expiration: ⤷  Try a Trial

Patent: 13056902
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 7661
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 07008562
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 6435
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 3659
Estimated Expiration: ⤷  Try a Trial

Patent: 073722
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 8870
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 0705793
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1648495
Estimated Expiration: ⤷  Try a Trial

Patent: 1918188
Estimated Expiration: ⤷  Try a Trial

Patent: 070094848
Estimated Expiration: ⤷  Try a Trial

Patent: 160098530
Estimated Expiration: ⤷  Try a Trial

Patent: 170096221
Estimated Expiration: ⤷  Try a Trial

Patent: 180056804
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 05611
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 80830
Estimated Expiration: ⤷  Try a Trial

Patent: 0637614
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 036
Estimated Expiration: ⤷  Try a Trial

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
Mexico 2007008562 COMPOSICIONES FARMACEUTICAS DE BENDAMUSTINA PARA LIOFILIZACION. (BENDAMUSTINE PHARMACEUTICAL COMPOSITIONS FOR LYOPHILISATION.) ⤷  Try a Trial
Japan 2013056902 BENDAMUSTINE PHARMACEUTICAL COMPOSITIONS ⤷  Try a Trial
Argentina 052877 COMPOSICIONES FARMACEUTICAS DE BENDAMUSTINA ⤷  Try a Trial
China 101119708 Bendamustine pharmaceutical compositions ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
McKesson
AstraZeneca
Express Scripts
Johnson and Johnson
Medtronic

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.