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Last Updated: June 14, 2024

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 nine patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-four 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. Ten suppliers are listed for this compound. Additional details are available on the bendamustine hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Belrapzo

A generic version of BELRAPZO was approved as bendamustine hydrochloride by ACCORD HLTHCARE on December 7th, 2022.

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Summary for BELRAPZO
International Patents:64
US Patents:9
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 sixteen US patents.

Patents protecting BELRAPZO

Formulations of bendamustine
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Formulations of bendamustine
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Patented Use: FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA

Formulations of bendamustine
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Patented Use: FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA


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Patented Use: FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA


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Patented Use: FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA


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Patented Use: FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA


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Formulations of bendamustine
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Patented Use: FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA

Formulations of bendamustine
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Patented Use: FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA

Bendamustine pharmaceutical compositions
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Patented Use: FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA

Bendamustine pharmaceutical compositions
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Patented Use: FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA

Formulations of bendamustine
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Formulations of bendamustine
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA

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

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

Formulations of bendamustine
Patent Number: ⤷  Sign Up
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Patented Use: FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA

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;INTRAVENOUS 205580-001 May 15, 2018 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Eagle Pharms BELRAPZO bendamustine hydrochloride SOLUTION;INTRAVENOUS 205580-001 May 15, 2018 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Eagle Pharms BELRAPZO bendamustine hydrochloride SOLUTION;INTRAVENOUS 205580-001 May 15, 2018 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Eagle Pharms BELRAPZO bendamustine hydrochloride SOLUTION;INTRAVENOUS 205580-001 May 15, 2018 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Eagle Pharms BELRAPZO bendamustine hydrochloride SOLUTION;INTRAVENOUS 205580-001 May 15, 2018 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Eagle Pharms BELRAPZO bendamustine hydrochloride SOLUTION;INTRAVENOUS 205580-001 May 15, 2018 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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: ⤷  Sign Up

Australia

Patent: 06204817
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Brazil

Patent: 0606332
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 93582
Estimated Expiration: ⤷  Sign Up

China

Patent: 1119708
Estimated Expiration: ⤷  Sign Up

Patent: 2078305
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Eurasian Patent Organization

Patent: 3324
Estimated Expiration: ⤷  Sign Up

Patent: 0701511
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European Patent Office

Patent: 63452
Estimated Expiration: ⤷  Sign Up

Patent: 74334
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Hong Kong

Patent: 16073
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 88195
Estimated Expiration: ⤷  Sign Up

Patent: 26833
Estimated Expiration: ⤷  Sign Up

Patent: 08526991
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Patent: 13056901
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Patent: 13056902
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Malaysia

Patent: 7661
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Mexico

Patent: 07008562
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New Zealand

Patent: 6435
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Norway

Patent: 3659
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Patent: 073722
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Singapore

Patent: 8870
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South Africa

Patent: 0705793
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South Korea

Patent: 1648495
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Patent: 1918188
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Patent: 070094848
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Patent: 160098530
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Patent: 170096221
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Patent: 180056804
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Spain

Patent: 05611
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Taiwan

Patent: 80830
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Patent: 0637614
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Ukraine

Patent: 036
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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
Ukraine 94036 ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ БЕНДАМУСТИНА, ПРЕДНАЗНАЧЕННАЯ ДЛЯ ЛИОФИЛИЗАЦИИ;ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ БЕНДАМУСТИНУ, ПРИЗНАЧЕНА ДЛЯ ЛІОФІЛІЗАЦІЇ (BENDAMUSTINE PHARMACEUTICAL COMPOSITIONS FOR LYOPHILISATION) ⤷  Sign Up
Spain 2405611 ⤷  Sign Up
European Patent Office 3158991 FORMULATIONS DE BENDAMUSTINE (FORMULATIONS OF BENDAMUSTINE) ⤷  Sign Up
Singapore 158870 BENDAMUSTINE PHARMACEUTICAL COMPOSITIONS FOR LYOPHILISATION ⤷  Sign Up
Japan 5688195 ⤷  Sign Up
Mexico 2007008562 COMPOSICIONES FARMACEUTICAS DE BENDAMUSTINA PARA LIOFILIZACION. (BENDAMUSTINE PHARMACEUTICAL COMPOSITIONS FOR LYOPHILISATION.) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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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.