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.
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 |
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 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
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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
Formulations of bendamustine
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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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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 | |||
>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
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Canada
Patent: 93582
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China
Patent: 1119708
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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
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Japan
Patent: 88195
Estimated Expiration: ⤷ Sign Up
Patent: 26833
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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 |
---|---|---|---|
Japan | 2013056901 | BENDAMUSTINE PHARMACEUTICAL COMPOSITION | ⤷ Sign Up |
European Patent Office | 3158991 | FORMULATIONS DE BENDAMUSTINE (FORMULATIONS OF BENDAMUSTINE) | ⤷ Sign Up |
Mexico | 2007008562 | COMPOSICIONES FARMACEUTICAS DE BENDAMUSTINA PARA LIOFILIZACION. (BENDAMUSTINE PHARMACEUTICAL COMPOSITIONS FOR LYOPHILISATION.) | ⤷ Sign Up |
Taiwan | 200637614 | Bendamustine pharmaceutical compositions | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |