BELRAPZO Drug Patent Profile
✉ Email this page to a colleague
▶ Start for $1
Remove trial restrictions
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.
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.
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 |
Recent Clinical Trials for BELRAPZO
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Cancer Institute (NCI) | Phase 1 |
| City of Hope Medical Center | Phase 1 |
| National Cancer Institute (NCI) | Phase 3 |
Pharmacology for BELRAPZO
| Drug Class | Alkylating Drug |
| Mechanism of Action | Alkylating Activity |
Anatomical Therapeutic Chemical (ATC) Classes for BELRAPZO
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 |
Make Better Decisions: Try a trial or see plans & pricing
Serving leading biopharmaceutical companies globally:
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.
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2023 - 2024
NCE-1 Patent Challenge Dates 2023 - 2024
DrugChatter - AI-based answers to questions about drugs
RxJam - Trigger-based marketing for life sciences
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2023, www.DrugPatentWatch.com.
Follow DrugPatentWatch:
