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. Eleven 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 |
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 |
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
Patent Number: ⤷ Sign Up
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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
Patent Expiration: ⤷ Sign Up
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 | ||
| 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
Patent: COMPOSICIONES FARMACEUTICAS DE BENDAMUSTINA
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 06204817
Patent: Bendamustine pharmaceutical compositions for lyophilisation
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0606332
Patent: composição farmacêutica de bendamustina, preparação liofilizada, forma de dosagem farmacêutica, método para obter aprovação oficial para um produto de bendamustina, processo para fabricar uma preparação liofilizada de bendamustina, solução ou dispersão de pré-liofilização de bendamustina, pó liofilizado, método para preparar uma preparação liofilizada de bendamustina, formulação para liofilização, e, uso de uma solução farmaceuticamente aceitável
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 93582
Patent: COMPOSITIONS PHARMACEUTIQUES DE BENDAMUSTINE (BENDAMUSTINE PHARMACEUTICAL COMPOSITIONS FOR LYOPHILISATION)
Estimated Expiration: ⤷ Sign Up
China
Patent: 1119708
Patent: Bendamustine pharmaceutical compositions
Estimated Expiration: ⤷ Sign Up
Patent: 2078305
Patent: Bendamustine pharmaceutical compositions
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 3324
Patent: ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ БЕНДАМУСТИНА, ПРЕДНАЗНАЧЕННЫЕ ДЛЯ ЛИОФИЛИЗАЦИИ (BENDAMUSTINE PHARMACEUTICAL COMPOSITIONS FOR LYOPHILIZATION)
Estimated Expiration: ⤷ Sign Up
Patent: 0701511
Patent: ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ БЕНДАМУСТИНА, ПРЕДНАЗНАЧЕННЫЕ ДЛЯ ЛИОФИЛИЗАЦИИ
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 63452
Patent: COMPOSITIONS PHARMACEUTIQUES DE BENDAMUSTINE POUR LYPOPHILISER (BENDAMUSTINE PHARMACEUTICAL COMPOSITIONS FOR LYOPHILISATION)
Estimated Expiration: ⤷ Sign Up
Patent: 74334
Patent: Compositions pharmaceutiques de bendamustine pour lyophilisation (Bendamustine pharmaceutical compositions for lyophilisation)
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 16073
Patent: BENDAMUSTINE PHARMACEUTICAL COMPOSITIONS FOR LYOPHILISATION
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 88195
Estimated Expiration: ⤷ Sign Up
Patent: 26833
Estimated Expiration: ⤷ Sign Up
Patent: 08526991
Estimated Expiration: ⤷ Sign Up
Patent: 13056901
Patent: BENDAMUSTINE PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷ Sign Up
Patent: 13056902
Patent: BENDAMUSTINE PHARMACEUTICAL COMPOSITIONS
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 7661
Patent: BENDAMUSTINE PHARMACEUTICAL COMPOSITIONS
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 07008562
Patent: COMPOSICIONES FARMACEUTICAS DE BENDAMUSTINA PARA LIOFILIZACION. (BENDAMUSTINE PHARMACEUTICAL COMPOSITIONS FOR LYOPHILISATION.)
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 6435
Patent: Bendamustine pharmaceutical compositions for lyophilisation
Estimated Expiration: ⤷ Sign Up
Norway
Patent: 3659
Estimated Expiration: ⤷ Sign Up
Patent: 073722
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 8870
Patent: BENDAMUSTINE PHARMACEUTICAL COMPOSITIONS FOR LYOPHILISATION
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 0705793
Patent: Bendamustine pharmaceutical compositions for lyophilisation
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1648495
Estimated Expiration: ⤷ Sign Up
Patent: 1918188
Estimated Expiration: ⤷ Sign Up
Patent: 070094848
Patent: BENDAMUSTINE PHARMACEUTICAL COMPOSITIONS FOR LYOPHILISATION
Estimated Expiration: ⤷ Sign Up
Patent: 160098530
Patent: 동결건조를 위한 벤다무스틴 약학 조성물 (BENDAMUSTINE PHARMACEUTICAL COMPOSITIONS FOR LYOPHILISATION)
Estimated Expiration: ⤷ Sign Up
Patent: 170096221
Patent: 동결건조를 위한 벤다무스틴 약학 조성물 (BENDAMUSTINE PHARMACEUTICAL COMPOSITIONS FOR LYOPHILISATION)
Estimated Expiration: ⤷ Sign Up
Patent: 180056804
Patent: 동결건조를 위한 벤다무스틴 약학 조성물 (BENDAMUSTINE PHARMACEUTICAL COMPOSITIONS FOR LYOPHILISATION)
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 05611
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 80830
Estimated Expiration: ⤷ Sign Up
Patent: 0637614
Patent: Bendamustine pharmaceutical compositions
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 036
Patent: ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ БЕНДАМУСТИНА, ПРЕДНАЗНАЧЕННАЯ ДЛЯ ЛИОФИЛИЗАЦИИ;ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ БЕНДАМУСТИНУ, ПРИЗНАЧЕНА ДЛЯ ЛІОФІЛІЗАЦІЇ (BENDAMUSTINE PHARMACEUTICAL COMPOSITIONS FOR LYOPHILISATION)
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| Portugal | 3158991 | ⤷ Sign Up | |
| South Korea | 20170096221 | 동결건조를 위한 벤다무스틴 약학 조성물 (BENDAMUSTINE PHARMACEUTICAL COMPOSITIONS FOR LYOPHILISATION) | ⤷ Sign Up |
| South Korea | 20180056804 | 동결건조를 위한 벤다무스틴 약학 조성물 (BENDAMUSTINE PHARMACEUTICAL COMPOSITIONS FOR LYOPHILISATION) | ⤷ Sign Up |
| Portugal | 2528602 | ⤷ Sign Up | |
| New Zealand | 556435 | Bendamustine pharmaceutical compositions for lyophilisation | ⤷ Sign Up |
| European Patent Office | 1863452 | COMPOSITIONS PHARMACEUTIQUES DE BENDAMUSTINE POUR LYPOPHILISER (BENDAMUSTINE PHARMACEUTICAL COMPOSITIONS FOR LYOPHILISATION) | ⤷ 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.
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