Bendeka is a drug owned by Eagle Pharmaceuticals Inc. It is protected by 19 US drug patents filed from 2015 to 2024 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 15, 2033. Details of Bendeka's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9000021 | Method of treating bendamustine-responsive conditions in patients requiring reduced volumes for administration |
Mar, 2033
(8 years from now) | Active |
| US9597397 | Formulations of bendamustine |
Mar, 2033
(8 years from now) | Active |
| US9597398 | Formulations of bendamustine |
Mar, 2033
(8 years from now) | Active |
| US9034908 | Formulations of bendamustine |
Mar, 2033
(8 years from now) | Active |
| US9597399 | Formulations of bendamustine |
Mar, 2033
(8 years from now) | Active |
| US10052385 | Formulations of bendamustine |
Mar, 2033
(8 years from now) | Active |
| US9572887 | Formulations of bendamustine |
Mar, 2033
(8 years from now) | Active |
| US9144568 | Formulations of bendamustine |
Mar, 2033
(8 years from now) | Active |
| US9579384 | Method of treating bendamustine-responsive conditions in patients requiring reduced volumes for administration |
Mar, 2033
(8 years from now) | Active |
| US8609707 | Formulations of bendamustine |
Aug, 2031
(6 years from now) | Active |
| US9265831 | Formulations of bendamustine |
Jan, 2031
(6 years from now) | Active |
| US9572797 | Formulations of bendamustine |
Jan, 2031
(6 years from now) | Active |
| US9572796 | Formulations of bendamustine |
Jan, 2031
(6 years from now) | Active |
| US11103483 | Formulations of bendamustine |
Jan, 2031
(6 years from now) | Active |
| US11844783 | Formulations of bendamustine |
Jan, 2031
(6 years from now) | Active |
| US11872214 | Formulations of Bendamustine |
Jan, 2031
(6 years from now) | Active |
| US10010533 | Formulations of bendamustine |
Jan, 2031
(6 years from now) | Active |
|
US8791270 (Pediatric) | Bendamustine pharmaceutical compositions |
Jul, 2026
(1 year, 7 months from now) | Active |
| US8791270 | Bendamustine pharmaceutical compositions |
Jan, 2026
(1 year, 1 month from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Bendeka's patents.
Latest Legal Activities on Bendeka's Patents
Given below is the list of recent legal activities going on the following patents of Bendeka.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Mail Patent eGrant Notification | 16 Jan, 2024 | US11872214 |
| Recordation of Patent Grant Mailed Critical | 16 Jan, 2024 | US11872214 |
| Patent Issue Date Used in PTA Calculation Critical | 16 Jan, 2024 | US11872214 |
| Patent eGrant Notification | 16 Jan, 2024 | US11872214 |
| Email Notification Critical | 16 Jan, 2024 | US11872214 |
| Recordation of Patent eGrant | 16 Jan, 2024 | US11872214 |
| Email Notification Critical | 28 Dec, 2023 | US11872214 |
| Issue Notification Mailed Critical | 27 Dec, 2023 | US11872214 |
| Email Notification Critical | 20 Dec, 2023 | US11844783 |
| Patent eGrant Notification | 19 Dec, 2023 | US11844783 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Bendeka and ongoing litigations to help you estimate the early arrival of Bendeka generic.
Bendeka's Litigations
Bendeka been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Oct 09, 2015, against patent number US8791270. The petitioner AGILA SPECIALTIES INC., challenged the validity of this patent, with Cephalon, Inc. as the respondent. Click below to track the latest information on how companies are challenging Bendeka's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8791270 | October, 2015 |
Terminated-Settled
(25 Aug, 2016) | Cephalon, Inc. | Fresenius Kabi USA, LLC |
| US8791270 | October, 2015 |
Terminated-Denied
(13 Apr, 2016) | Cephalon, Inc. | AGILA SPECIALTIES INC. |
FDA has granted some exclusivities to Bendeka. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Bendeka, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Bendeka.
Exclusivity Information
Bendeka holds 1 exclusivities. All of its exclusivities have expired in 2022. Details of Bendeka's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| Orphan Drug Exclusivity(ODE-179) | Dec 07, 2022 |
Several oppositions have been filed on Bendeka's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Bendeka's generic, the next section provides detailed information on ongoing and past EP oppositions related to Bendeka patents.
Bendeka's Oppositions Filed in EPO
Bendeka has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Dec 12, 2013, by Helm Ag. This opposition was filed on patent number EP06718390A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP11737745A | Jul, 2017 | Fresenius Kabi Deutschland GmbH | Patent maintained as amended |
| EP11737745A | Jul, 2017 | isarpatent - Patent- und Rechtsanwälte Behnisch Barth Charles Hassa Peckmann und Partner mbB | Patent maintained as amended |
| EP11737745A | Jul, 2017 | FRKelly | Patent maintained as amended |
| EP11737745A | Jul, 2017 | Wittkopp, Alexander | Patent maintained as amended |
| EP06718390A | Jan, 2014 | Accord Healthcare | Revoked |
| EP06718390A | Jan, 2014 | Bendalis GmbH | Revoked |
| EP06718390A | Jan, 2014 | Gallafent, Alison | Revoked |
| EP06718390A | Jan, 2014 | Taylor Wessing LLP | Revoked |
| EP06718390A | Dec, 2013 | Actavis Group PTC ehf | Revoked |
| EP06718390A | Dec, 2013 | LEK Pharmaceuticals d.d. | Revoked |
| EP06718390A | Dec, 2013 | Helm AG | Revoked |
US patents provide insights into the exclusivity only within the United States, but Bendeka is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Bendeka's family patents as well as insights into ongoing legal events on those patents.
Bendeka's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Bendeka's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 15, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Bendeka Generic API suppliers:
Bendamustine Hydrochloride is the generic name for the brand Bendeka. 11 different companies have already filed for the generic of Bendeka, with Accord Hlthcare having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Bendeka's generic
How can I launch a generic of Bendeka before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Bendeka's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Bendeka's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Bendeka -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 100 mg/4 mL (25 mg/mL) multiple-dose vials | 04 May, 2017 | 1 | 15 Mar, 2033 |
Alternative Brands for Bendeka
Bendeka which is used for treating patients with chronic lymphocytic leukemia and indolent B-cell non-Hodgkin lymphoma., has several other brand drugs in the same treatment category and using the same active ingredient (Bendamustine Hydrochloride). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Cephalon |
| |||
| Eagle Pharms |
| |||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Bendamustine Hydrochloride. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Azurity |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Bendamustine Hydrochloride, Bendeka's active ingredient. Check the complete list of approved generic manufacturers for Bendeka
About Bendeka
Bendeka is a drug owned by Eagle Pharmaceuticals Inc. It is used for treating patients with chronic lymphocytic leukemia and indolent B-cell non-Hodgkin lymphoma. Bendeka uses Bendamustine Hydrochloride as an active ingredient. Bendeka was launched by Eagle Pharms in 2015.
Approval Date:
Bendeka was approved by FDA for market use on 07 December, 2015.
Active Ingredient:
Bendeka uses Bendamustine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Bendamustine Hydrochloride ingredient
Treatment:
Bendeka is used for treating patients with chronic lymphocytic leukemia and indolent B-cell non-Hodgkin lymphoma.
Dosage:
Bendeka is available in solution form for iv (infusion) use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 100MG/4ML (25MG/ML) | SOLUTION | Prescription | IV (INFUSION) |