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Last Updated: May 20, 2022

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-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

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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
Drug patent expirations by year for BELRAPZO
DrugPatentWatch® Estimated Generic Entry Opportunity Date for BELRAPZO
Generic Entry Date for BELRAPZO*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
City of Hope Medical CenterPhase 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 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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of BELRAPZO is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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

Formulations of bendamustine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Formulations of bendamustine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA

Formulations of bendamustine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA

Formulations of bendamustine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA

Formulations of bendamustine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA

Bendamustine pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA

Bendamustine pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA

Formulations of bendamustine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Formulations of bendamustine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA

Formulations of bendamustine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA

Formulations of bendamustine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA

Formulations of bendamustine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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;IV (INFUSION) 205580-001 May 15, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Eagle Pharms BELRAPZO bendamustine hydrochloride SOLUTION;IV (INFUSION) 205580-001 May 15, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Eagle Pharms BELRAPZO bendamustine hydrochloride SOLUTION;IV (INFUSION) 205580-001 May 15, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Eagle Pharms BELRAPZO bendamustine hydrochloride SOLUTION;IV (INFUSION) 205580-001 May 15, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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: See Plans and Pricing

Australia

Patent: 06204817
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0606332
Estimated Expiration: See Plans and Pricing

Canada

Patent: 93582
Estimated Expiration: See Plans and Pricing

China

Patent: 1119708
Estimated Expiration: See Plans and Pricing

Patent: 2078305
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 3324
Estimated Expiration: See Plans and Pricing

Patent: 0701511
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 63452
Estimated Expiration: See Plans and Pricing

Patent: 74334
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 16073
Estimated Expiration: See Plans and Pricing

Israel

Patent: 4394
Estimated Expiration: See Plans and Pricing

Japan

Patent: 88195
Estimated Expiration: See Plans and Pricing

Patent: 26833
Estimated Expiration: See Plans and Pricing

Patent: 08526991
Estimated Expiration: See Plans and Pricing

Patent: 13056901
Estimated Expiration: See Plans and Pricing

Patent: 13056902
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 7661
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 07008562
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 6435
Estimated Expiration: See Plans and Pricing

Norway

Patent: 3659
Estimated Expiration: See Plans and Pricing

Patent: 073722
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 8870
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0705793
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1648495
Estimated Expiration: See Plans and Pricing

Patent: 1918188
Estimated Expiration: See Plans and Pricing

Patent: 070094848
Estimated Expiration: See Plans and Pricing

Patent: 160098530
Estimated Expiration: See Plans and Pricing

Patent: 170096221
Estimated Expiration: See Plans and Pricing

Patent: 180056804
Estimated Expiration: See Plans and Pricing

Spain

Patent: 05611
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 80830
Estimated Expiration: See Plans and Pricing

Patent: 0637614
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 036
Estimated Expiration: See Plans and Pricing

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) See Plans and Pricing
Portugal 3158991 See Plans and Pricing
Japan 2008526991 See Plans and Pricing
Hungary E031208 See Plans and Pricing
>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.