BENDEKA Drug Patent Profile
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Which patents cover Bendeka, and what generic alternatives are available?
Bendeka is a drug marketed by Eagle Pharms and is included in one NDA. There are eighteen patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and twenty-four patent family members in thirty-one countries.
The generic ingredient in BENDEKA 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 Bendeka
A generic version of BENDEKA was approved as bendamustine hydrochloride by ACCORD HLTHCARE on December 7th, 2022.
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Summary for BENDEKA
| International Patents: | 124 |
| US Patents: | 18 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 129 |
| Clinical Trials: | 21 |
| Drug Prices: | Drug price information for BENDEKA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BENDEKA |
| What excipients (inactive ingredients) are in BENDEKA? | BENDEKA excipients list |
| DailyMed Link: | BENDEKA at DailyMed |
Recent Clinical Trials for BENDEKA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Wisconsin, Madison | Phase 1/Phase 2 |
| Epizyme, Inc. | Phase 1/Phase 2 |
| Vaishalee Kenkre | Phase 1/Phase 2 |
Pharmacology for BENDEKA
| Drug Class | Alkylating Drug |
| Mechanism of Action | Alkylating Activity |
Paragraph IV (Patent) Challenges for BENDEKA
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| BENDEKA | Injection | bendamustine hydrochloride | 100 mg/4 mL (25 mg/mL) multiple-dose vials | 208194 | 1 | 2017-05-04 |
US Patents and Regulatory Information for BENDEKA
BENDEKA is protected by twenty-eight US patents.
Patents protecting BENDEKA
Formulations of bendamustine
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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
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 INDOLENT B-CELL NON-HODGKIN LYMPHOMA
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Patented Use: FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
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Formulations of bendamustine
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Patented Use: FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA
Bendamustine pharmaceutical compositions
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Patented Use: FOR USE IN TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR NON-HODGKIN'S LYMPHOMA
Method of treating bendamustine-responsive conditions in patients requiring reduced volumes for administration
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Patented Use: FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA
Formulations of bendamustine
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Patented Use: FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA
Formulations of bendamustine
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Patented Use: FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA
Formulations of bendamustine
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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
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
Method of treating bendamustine-responsive conditions in patients requiring reduced volumes for administration
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
Method of treating bendamustine-responsive conditions in patients requiring reduced volumes for administration
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
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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 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 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 | BENDEKA | bendamustine hydrochloride | SOLUTION;IV (INFUSION) | 208194-001 | Dec 7, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Eagle Pharms | BENDEKA | bendamustine hydrochloride | SOLUTION;IV (INFUSION) | 208194-001 | Dec 7, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Eagle Pharms | BENDEKA | bendamustine hydrochloride | SOLUTION;IV (INFUSION) | 208194-001 | Dec 7, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Eagle Pharms | BENDEKA | bendamustine hydrochloride | SOLUTION;IV (INFUSION) | 208194-001 | Dec 7, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Eagle Pharms | BENDEKA | bendamustine hydrochloride | SOLUTION;IV (INFUSION) | 208194-001 | Dec 7, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Eagle Pharms | BENDEKA | bendamustine hydrochloride | SOLUTION;IV (INFUSION) | 208194-001 | Dec 7, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Eagle Pharms | BENDEKA | bendamustine hydrochloride | SOLUTION;IV (INFUSION) | 208194-001 | Dec 7, 2015 | 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 BENDEKA
When does loss-of-exclusivity occur for BENDEKA?
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 BENDEKA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Brazil | PI0606332 | 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 | ⤷ Sign Up |
| Portugal | 2827863 | ⤷ Sign Up | |
| Japan | 2020143143 | 低減された投与容量を必要とする患者におけるベンダムスチン応答性症状の治療方法 (METHOD OF TREATING BENDAMUSTINE-RESPONSIVE CONDITIONS IN PATIENTS REQUIRING REDUCED VOLUMES FOR ADMINISTRATION) | ⤷ Sign Up |
| European Patent Office | 2827863 | COMPOSITION LIQUIDE DESTINÉE À ÊTRE UTILISÉE DANS UN MÉTHODE DE TRAITEMENT DES ÉTATS RÉAGISSANT À LA BENDAMUSTINE CHEZ DES PATIENTS NÉCESSITANT DES VOLUMES RÉDUITS POUR L'ADMINISTRATION (LIQUID COMPOSITION FOR USE IN A METHOD OF TREATING BENDAMUSTINE-RESPONSIVE CONDITIONS IN PATIENTS REQUIRING REDUCED VOLUMES FOR ADMINISTRATION) | ⤷ Sign Up |
| Japan | 2013056901 | BENDAMUSTINE PHARMACEUTICAL COMPOSITION | ⤷ Sign Up |
| Spain | 2875374 | ⤷ Sign Up | |
| European Patent Office | 3533447 | COMPOSITIONS LIQUIDES DE BENDAMUSTINE POUR L'UTILISATION DANS LE TRAITEMENT DE MALADIES SENSIBLES À LA BENDAMUSTINE CHEZ DES PATIENTS NÉCESSITANT DES VOLUMES RÉDUITE POUR L'ADMINISTRATION (BENDAMUSTINE LIQUID COMPOSITIONS FOR USE IN METHOD OF TREATING BENDAMUSTINE-RESPONSIVE CONDITIONS IN PATIENTS REQUIRING REDUCED VOLUMES FOR ADMINISTRATION) | ⤷ 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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