Bendamustine Hydrochloride Patent Expiration

Bendamustine Hydrochloride was first introduced by Cephalon Inc in its drug Treanda on Mar 20, 2008. Other drugs containing Bendamustine Hydrochloride are Vivimusta, Belrapzo, Bendamustine Hydrochloride, Bendeka. 16 different companies have introduced drugs containing Bendamustine Hydrochloride.


Bendamustine Hydrochloride Patents

Given below is the list of patents protecting Bendamustine Hydrochloride, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Belrapzo US10010533 Formulations of bendamustine Jan 28, 2031 Eagle Pharms
Belrapzo US11103483 Formulations of bendamustine Jan 28, 2031 Eagle Pharms
Belrapzo US11844783 Formulations of bendamustine Jan 28, 2031 Eagle Pharms
Belrapzo US11872214 Formulations of Bendamustine Jan 28, 2031 Eagle Pharms
Belrapzo US8609707 Formulations of bendamustine Aug 11, 2031 Eagle Pharms
Belrapzo US8791270 Bendamustine pharmaceutical compositions Jan 12, 2026 Eagle Pharms
Belrapzo US9265831 Formulations of bendamustine Jan 28, 2031 Eagle Pharms
Belrapzo US9572796 Formulations of bendamustine Jan 28, 2031 Eagle Pharms
Belrapzo US9572797 Formulations of bendamustine Jan 28, 2031 Eagle Pharms
Bendeka US10010533 Formulations of bendamustine Jan 28, 2031 Eagle Pharms
Bendeka US10052385 Formulations of bendamustine Mar 15, 2033 Eagle Pharms
Bendeka US11103483 Formulations of bendamustine Jan 28, 2031 Eagle Pharms
Bendeka US11844783 Formulations of bendamustine Jan 28, 2031 Eagle Pharms
Bendeka US11872214 Formulations of Bendamustine Jan 28, 2031 Eagle Pharms
Bendeka US8609707 Formulations of bendamustine Aug 11, 2031 Eagle Pharms
Bendeka US8791270 Bendamustine pharmaceutical compositions Jan 12, 2026 Eagle Pharms
Bendeka US8791270

(Pediatric)

Bendamustine pharmaceutical compositions Jul 12, 2026 Eagle Pharms
Bendeka US9000021 Method of treating bendamustine-responsive conditions in patients requiring reduced volumes for administration Mar 15, 2033 Eagle Pharms
Bendeka US9034908 Formulations of bendamustine Mar 15, 2033 Eagle Pharms
Bendeka US9144568 Formulations of bendamustine Mar 15, 2033 Eagle Pharms
Bendeka US9265831 Formulations of bendamustine Jan 28, 2031 Eagle Pharms
Bendeka US9572796 Formulations of bendamustine Jan 28, 2031 Eagle Pharms
Bendeka US9572797 Formulations of bendamustine Jan 28, 2031 Eagle Pharms
Bendeka US9572887 Formulations of bendamustine Mar 15, 2033 Eagle Pharms
Bendeka US9579384 Method of treating bendamustine-responsive conditions in patients requiring reduced volumes for administration Mar 15, 2033 Eagle Pharms
Bendeka US9597397 Formulations of bendamustine Mar 15, 2033 Eagle Pharms
Bendeka US9597398 Formulations of bendamustine Mar 15, 2033 Eagle Pharms
Bendeka US9597399 Formulations of bendamustine Mar 15, 2033 Eagle Pharms
Treanda US8344006 Liquid formulations of bendamustine Sep 23, 2029 Cephalon
Treanda US8344006

(Pediatric)

Liquid formulations of bendamustine Mar 23, 2030 Cephalon
Treanda US8436190 Bendamustine pharmaceutical compositions Oct 26, 2030 Cephalon
Treanda US8436190

(Pediatric)

Bendamustine pharmaceutical compositions Apr 26, 2031 Cephalon
Treanda US8445524 Solid forms of bendamustine hydrochloride Mar 26, 2029 Cephalon
Treanda US8445524

(Pediatric)

Solid forms of bendamustine hydrochloride Sep 26, 2029 Cephalon
Treanda US8609863 Bendamustine pharmaceutical compositions Jan 12, 2026 Cephalon
Treanda US8609863

(Pediatric)

Bendamustine pharmaceutical compositions Jul 12, 2026 Cephalon
Treanda US8669279 Solid forms of bendamustine hydrochloride Mar 26, 2029 Cephalon
Treanda US8669279

(Pediatric)

Solid forms of bendamustine hydrochloride Sep 26, 2029 Cephalon
Treanda US8791270 Bendamustine pharmaceutical compositions Jan 12, 2026 Cephalon
Treanda US8791270

(Pediatric)

Bendamustine pharmaceutical compositions Jul 12, 2026 Cephalon
Treanda US8883836 Solid forms of bendamustine hydrochloride Mar 26, 2029 Cephalon
Treanda US8883836

(Pediatric)

Solid forms of bendamustine hydrochloride Sep 26, 2029 Cephalon
Treanda US8895756 Bendamustine pharmaceutical compositions Jan 12, 2026 Cephalon
Treanda US8895756

(Pediatric)

Bendamustine pharmaceutical compositions Jul 12, 2026 Cephalon
Treanda US9533955 Solid forms of bendamustine hydrochloride Mar 26, 2029 Cephalon
Treanda US9533955

(Pediatric)

Solid forms of bendamustine hydrochloride Sep 26, 2029 Cephalon
Vivimusta US11844784 Stable pharmaceutical compositions of bendamustine Jul 29, 2042 Slayback Pharma Llc


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 Bendamustine Hydrochloride's patents.

Given below is the list recent legal activities going on the following patents of Bendamustine Hydrochloride.

Event Date Patent/Publication
Patent litigations
Payment of Maintenance Fee, 8th Year, Large Entity 20 Jun, 2024 US9533955
Payment of Maintenance Fee, 12th Year, Large Entity 19 Jun, 2024 US8344006
Email Notification 20 Dec, 2023 US11844784
Recordation of Patent Grant Mailed 19 Dec, 2023 US11844784
Patent eGrant Notification 19 Dec, 2023 US11844784
Mail Patent eGrant Notification 19 Dec, 2023 US11844784
Patent Issue Date Used in PTA Calculation 19 Dec, 2023 US11844784
Recordation of Patent eGrant 19 Dec, 2023 US11844784
Email Notification 30 Nov, 2023 US11844784
Issue Notification Mailed 29 Nov, 2023 US11844784



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Bendamustine Hydrochloride Generics

Several generic applications have been filed for Bendamustine Hydrochloride. The first generic version for Bendamustine Hydrochloride was by Innopharma Licensing Llc and was approved on Mar 24, 2016. And the latest generic version is by Nang Kuang Pharmaceutical Co Ltd and was approved on Jun 7, 2023.

Given below is the list of companies who have filed for Bendamustine Hydrochloride generic.


1. ACCORD HLTHCARE

Accord Healthcare Inc has filed for 2 different strengths of generic version for Bendamustine Hydrochloride. Given below are the details of the strengths of this generic introduced by Accord Hlthcare.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG/VIAL powder Prescription IV (INFUSION) AP Dec 7, 2022
100MG/VIAL powder Prescription IV (INFUSION) AP Dec 7, 2022


2. NANG KUANG PHARM CO

Nang Kuang Pharmaceutical Co Ltd has filed for 2 different strengths of generic version for Bendamustine Hydrochloride. Given below are the details of the strengths of this generic introduced by Nang Kuang Pharm Co.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG/VIAL powder Discontinued IV (INFUSION) N/A Jun 7, 2023
100MG/VIAL powder Discontinued IV (INFUSION) N/A Jun 7, 2023


3. DR REDDYS

Dr Reddys Laboratories Ltd has filed for 2 different strengths of generic version for Bendamustine Hydrochloride. Given below are the details of the strengths of this generic introduced by Dr Reddys.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG/VIAL powder Prescription IV (INFUSION) AP Dec 7, 2022
100MG/VIAL powder Prescription IV (INFUSION) AP Dec 7, 2022


4. INNOPHARMA LICENSING

Innopharma Licensing Llc has filed for 2 different strengths of generic version for Bendamustine Hydrochloride. Given below are the details of the strengths of this generic introduced by Innopharma Licensing.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/VIAL powder Prescription IV (INFUSION) AP Mar 24, 2016
25MG/VIAL powder Prescription IV (INFUSION) AP Mar 24, 2016


5. NORVIUM BIOSCIENCE

Norvium Bioscience Llc has filed for 2 different strengths of generic version for Bendamustine Hydrochloride. Given below are the details of the strengths of this generic introduced by Norvium Bioscience.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG/VIAL powder Discontinued IV (INFUSION) N/A Apr 28, 2023
100MG/VIAL powder Discontinued IV (INFUSION) N/A Apr 28, 2023


6. HOSPIRA INC

Hospira Inc has filed for 2 different strengths of generic version for Bendamustine Hydrochloride. Given below are the details of the strengths of this generic introduced by Hospira Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG/VIAL powder Prescription IV (INFUSION) AP May 20, 2016
100MG/VIAL powder Prescription IV (INFUSION) AP May 20, 2016


7. MEITHEAL

Meitheal Pharmaceuticals Inc has filed for 2 different strengths of generic version for Bendamustine Hydrochloride. Given below are the details of the strengths of this generic introduced by Meitheal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG/VIAL powder Prescription IV (INFUSION) AP Jun 5, 2023
100MG/VIAL powder Prescription IV (INFUSION) AP Jun 5, 2023


8. BRECKENRIDGE

Breckenridge Pharmaceutical Inc has filed for 2 different strengths of generic version for Bendamustine Hydrochloride. Given below are the details of the strengths of this generic introduced by Breckenridge.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG/VIAL powder Prescription IV (INFUSION) AP Feb 14, 2023
100MG/VIAL powder Prescription IV (INFUSION) AP Feb 14, 2023


9. EUGIA PHARMA

Eugia Pharma Specialities Ltd has filed for 2 different strengths of generic version for Bendamustine Hydrochloride. Given below are the details of the strengths of this generic introduced by Eugia Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/VIAL powder Prescription IV (INFUSION) AP Jun 5, 2023
25MG/VIAL powder Prescription IV (INFUSION) AP Jun 5, 2023


10. APOTEX

Apotex Inc has filed for 2 different strengths of generic version for Bendamustine Hydrochloride. Given below are the details of the strengths of this generic introduced by Apotex.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/VIAL powder Prescription IV (INFUSION) AP Jun 5, 2023
25MG/VIAL powder Prescription IV (INFUSION) AP Jun 5, 2023


11. GLENMARK PHARMS LTD

Glenmark Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Bendamustine Hydrochloride. Given below are the details of the strengths of this generic introduced by Glenmark Pharms Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG/VIAL powder Prescription IV (INFUSION) AP Mar 24, 2016
100MG/VIAL powder Prescription IV (INFUSION) AP Mar 24, 2016