Bendeka Drug Patent Profile
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Which patents cover Bendeka, and when can generic versions of Bendeka launch?
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 fourteen 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. Ten 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.
Summary for Bendeka
| International Patents: | 114 |
| US Patents: | 18 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 129 |
| Clinical Trials: | 21 |
| Formulation / Manufacturing: | see details |
| 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 |
|---|---|
| Vaishalee Kenkre | Phase 1/Phase 2 |
| University of Wisconsin, Madison | Phase 1/Phase 2 |
| Epizyme, Inc. | Phase 1/Phase 2 |
Pharmacology for Bendeka
| Drug Class | Alkylating Drug |
| Mechanism of Action | Alkylating Activity |
Anatomical Therapeutic Chemical (ATC) Classes for Bendeka
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
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 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 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
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
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 USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA
Bendamustine pharmaceutical compositions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA
Formulations of bendamustine
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA
Formulations of bendamustine
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS 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 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 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
Method of treating bendamustine-responsive conditions in patients requiring reduced volumes for administration
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ 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
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
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Eagle Pharms | BENDEKA | bendamustine hydrochloride | SOLUTION;IV (INFUSION) | 208194-001 | Dec 7, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Eagle Pharms | BENDEKA | bendamustine hydrochloride | SOLUTION;IV (INFUSION) | 208194-001 | Dec 7, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Eagle Pharms | BENDEKA | bendamustine hydrochloride | SOLUTION;IV (INFUSION) | 208194-001 | Dec 7, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Eagle Pharms | BENDEKA | bendamustine hydrochloride | SOLUTION;IV (INFUSION) | 208194-001 | Dec 7, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Eagle Pharms | BENDEKA | bendamustine hydrochloride | SOLUTION;IV (INFUSION) | 208194-001 | Dec 7, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Eagle Pharms | BENDEKA | bendamustine hydrochloride | SOLUTION;IV (INFUSION) | 208194-001 | Dec 7, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 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
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 Bendeka around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| 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) | ⤷ Try a Trial |
| South Korea | 20180056804 | 동결건조를 위한 벤다무스틴 약학 조성물 (BENDAMUSTINE PHARMACEUTICAL COMPOSITIONS FOR LYOPHILISATION) | ⤷ Try a Trial |
| Singapore | 158870 | BENDAMUSTINE PHARMACEUTICAL COMPOSITIONS FOR LYOPHILISATION | ⤷ Try a Trial |
| Portugal | 2827863 | ⤷ Try a Trial | |
| Spain | 2943668 | ⤷ Try a Trial | |
| Japan | 2013518130 | ⤷ Try a Trial | |
| World Intellectual Property Organization (WIPO) | 2013142359 | ⤷ Try a Trial | |
| >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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