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
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 |

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
Sponsor | Phase |
---|---|
City of Hope Medical Center | Phase 1 |
National Cancer Institute (NCI) | 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.
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 |