Bendamustine Hydrochloride Global Patent Coverage & Expiry Overview

Track protection status across key markets to assess launch feasibility.

It is formulated by 13 pharmaceutical companies such as CEPHALON, EAGLE PHARMS, ACCORD HLTHCARE and others. It is marketed under 5 brand names, including TREANDA, BENDEKA, BELRAPZO and others. Available in 7 different strengths, such as 180MG/2ML (90MG/ML), 45MG/0.5ML (90MG/ML), 100MG/4ML (25MG/ML) and others, and administered through 2 routes including SOLUTION;INTRAVENOUS, POWDER;INTRAVENOUS.

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Sourcing & Feasibility

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Orange Book Drug Approval Timeline

FDA approval history for this ingredient

NDA (New Drug Application) ANDA (Generic Application)

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US Orange Book Patents Expiration Timeline

Key expiration dates for US patents covering this ingredient

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Orange Book Drug Strengths

Latest drug strengths approved by FDA

Strength Route of Administration Companies Latest Approval Date

Orange Book Patents

Patents approved by the FDA for the ingredient

Patent Number Publication Date Legal Status Patent Expiry Date
{"application_id":"68851","ingredient":"BENDAMUSTINE HYDROCHLORIDE","trade_name":"TREANDA","family_id":"d72d12be6b164511a77e","publication_number":"US8609863B2","cleaned_patent_number":"8609863","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-07-12","publication_date":"2013-12-17","legal_status":"Granted"} US8609863B2 17 Dec, 2013 Granted 12 Jul, 2026
{"application_id":"68822","ingredient":"BENDAMUSTINE HYDROCHLORIDE","trade_name":"BELRAPZO","family_id":"d72d12be6b164511a77e","publication_number":"US8791270B2","cleaned_patent_number":"8791270","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-07-12","publication_date":"2014-07-29","legal_status":"Granted"} US8791270B2 29 Jul, 2014 Granted 12 Jul, 2026
{"application_id":"68852","ingredient":"BENDAMUSTINE HYDROCHLORIDE","trade_name":"TREANDA","family_id":"d72d12be6b164511a77e","publication_number":"US8895756B2","cleaned_patent_number":"8895756","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-07-12","publication_date":"2014-11-25","legal_status":"Granted"} US8895756B2 25 Nov, 2014 Granted 12 Jul, 2026
{"application_id":"5048","ingredient":"BENDAMUSTINE HYDROCHLORIDE","trade_name":"TREANDA","family_id":"fa53fc949c8e454cac0d","publication_number":"US9533955B2","cleaned_patent_number":"9533955","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-09-26","publication_date":"2017-01-03","legal_status":"Patented case"} US9533955B2 03 Jan, 2017 Patented case 26 Sep, 2029
{"application_id":"5043","ingredient":"BENDAMUSTINE HYDROCHLORIDE","trade_name":"TREANDA","family_id":"fa53fc949c8e454cac0d","publication_number":"US8883836B2","cleaned_patent_number":"8883836","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-09-26","publication_date":"2014-11-11","legal_status":"Granted"} US8883836B2 11 Nov, 2014 Granted 26 Sep, 2029
{"application_id":"5049","ingredient":"BENDAMUSTINE HYDROCHLORIDE","trade_name":"TREANDA","family_id":"fa53fc949c8e454cac0d","publication_number":"US8445524B2","cleaned_patent_number":"8445524","drug_product_flag":"-, Y","drug_substance_flag":"-, Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-09-26","publication_date":"2013-05-21","legal_status":"Patented case"} US8445524B2 21 May, 2013 Patented case 26 Sep, 2029
{"application_id":"5057","ingredient":"BENDAMUSTINE HYDROCHLORIDE","trade_name":"TREANDA","family_id":"fa53fc949c8e454cac0d","publication_number":"US8669279B2","cleaned_patent_number":"8669279","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-09-26","publication_date":"2014-03-11","legal_status":"Granted"} US8669279B2 11 Mar, 2014 Granted 26 Sep, 2029
{"application_id":"68860","ingredient":"BENDAMUSTINE HYDROCHLORIDE","trade_name":"TREANDA","family_id":"8aa79c0c2d5d4e6692b8","publication_number":"US8344006B2","cleaned_patent_number":"8344006","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-03-23","publication_date":"2013-01-01","legal_status":"Granted"} US8344006B2 01 Jan, 2013 Granted 23 Mar, 2030
{"application_id":"75751","ingredient":"BENDAMUSTINE HYDROCHLORIDE","trade_name":"BELRAPZO","family_id":"ad56443fe8e64eb09b6b","publication_number":"US10010533B2","cleaned_patent_number":"10010533","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-01-28","publication_date":"2018-07-03","legal_status":"Granted"} US10010533B2 Formulation 03 Jul, 2018 Granted 28 Jan, 2031
{"application_id":"75752","ingredient":"BENDAMUSTINE HYDROCHLORIDE","trade_name":"BELRAPZO","family_id":"ad56443fe8e64eb09b6b","publication_number":"US11103483B2","cleaned_patent_number":"11103483","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-01-28","publication_date":"2021-08-31","legal_status":"Granted"} US11103483B2 Formulation 31 Aug, 2021 Granted 28 Jan, 2031
{"application_id":"120810","ingredient":"BENDAMUSTINE HYDROCHLORIDE","trade_name":"BELRAPZO","family_id":"ad56443fe8e64eb09b6b","publication_number":"US11844783B2","cleaned_patent_number":"11844783","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-01-28","publication_date":"2023-12-19","legal_status":"Granted"} US11844783B2 19 Dec, 2023 Granted 28 Jan, 2031
{"application_id":"120812","ingredient":"BENDAMUSTINE HYDROCHLORIDE","trade_name":"BELRAPZO","family_id":"ad56443fe8e64eb09b6b","publication_number":"US11872214B2","cleaned_patent_number":"11872214","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-01-28","publication_date":"2024-01-16","legal_status":"Granted"} US11872214B2 Formulation 16 Jan, 2024 Granted 28 Jan, 2031
{"application_id":"139386","ingredient":"BENDAMUSTINE HYDROCHLORIDE","trade_name":"BELRAPZO","family_id":"ad56443fe8e64eb09b6b","publication_number":"US12138248B2","cleaned_patent_number":"12138248","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-01-28","publication_date":"2024-11-12","legal_status":"Granted"} US12138248B2 Formulation 12 Nov, 2024 Granted 28 Jan, 2031
{"application_id":"75749","ingredient":"BENDAMUSTINE HYDROCHLORIDE","trade_name":"BELRAPZO","family_id":"ad56443fe8e64eb09b6b","publication_number":"US9265831B2","cleaned_patent_number":"9265831","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-01-28","publication_date":"2016-02-23","legal_status":"Granted"} US9265831B2 Formulation 23 Feb, 2016 Granted 28 Jan, 2031
{"application_id":"75721","ingredient":"BENDAMUSTINE HYDROCHLORIDE","trade_name":"BELRAPZO","family_id":"ad56443fe8e64eb09b6b","publication_number":"US9572796B2","cleaned_patent_number":"9572796","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-01-28","publication_date":"2017-02-21","legal_status":"Granted"} US9572796B2 Formulation 21 Feb, 2017 Granted 28 Jan, 2031
{"application_id":"75750","ingredient":"BENDAMUSTINE HYDROCHLORIDE","trade_name":"BELRAPZO","family_id":"ad56443fe8e64eb09b6b","publication_number":"US9572797B2","cleaned_patent_number":"9572797","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-01-28","publication_date":"2017-02-21","legal_status":"Granted"} US9572797B2 21 Feb, 2017 Granted 28 Jan, 2031
{"application_id":"68849","ingredient":"BENDAMUSTINE HYDROCHLORIDE","trade_name":"TREANDA","family_id":"d72d12be6b164511a77e","publication_number":"US8436190B2","cleaned_patent_number":"8436190","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-04-26","publication_date":"2013-05-07","legal_status":"Granted"} US8436190B2 07 May, 2013 Granted 26 Apr, 2031
{"application_id":"75748","ingredient":"BENDAMUSTINE HYDROCHLORIDE","trade_name":"BELRAPZO","family_id":"ad56443fe8e64eb09b6b","publication_number":"US8609707B2","cleaned_patent_number":"8609707","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-08-11","publication_date":"2013-12-17","legal_status":"Granted"} US8609707B2 Formulation 17 Dec, 2013 Granted 11 Aug, 2031
{"application_id":"75787","ingredient":"BENDAMUSTINE HYDROCHLORIDE","trade_name":"BENDEKA","family_id":"49e9fa2718cf45a1b589","publication_number":"US9034908B2","cleaned_patent_number":"9034908","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-03-15","publication_date":"2015-05-19","legal_status":"Granted"} US9034908B2 19 May, 2015 Granted 15 Mar, 2033
{"application_id":"75758","ingredient":"BENDAMUSTINE HYDROCHLORIDE","trade_name":"BENDEKA","family_id":"49e9fa2718cf45a1b589","publication_number":"US9144568B1","cleaned_patent_number":"9144568","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-03-15","publication_date":"2015-09-29","legal_status":"Granted"} US9144568B2 29 Sep, 2015 Granted 15 Mar, 2033
{"application_id":"75791","ingredient":"BENDAMUSTINE HYDROCHLORIDE","trade_name":"BENDEKA","family_id":"49e9fa2718cf45a1b589","publication_number":"US9597397B2","cleaned_patent_number":"9597397","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-03-15","publication_date":"2017-03-21","legal_status":"Granted"} US9597397B2 21 Mar, 2017 Granted 15 Mar, 2033
{"application_id":"75794","ingredient":"BENDAMUSTINE HYDROCHLORIDE","trade_name":"BENDEKA","family_id":"49e9fa2718cf45a1b589","publication_number":"US10052385B2","cleaned_patent_number":"10052385","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-03-15","publication_date":"2018-08-21","legal_status":"Granted"} US10052385B2 21 Aug, 2018 Granted 15 Mar, 2033
{"application_id":"75792","ingredient":"BENDAMUSTINE HYDROCHLORIDE","trade_name":"BENDEKA","family_id":"49e9fa2718cf45a1b589","publication_number":"US9597398B2","cleaned_patent_number":"9597398","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-03-15","publication_date":"2017-03-21","legal_status":"Granted"} US9597398B2 21 Mar, 2017 Granted 15 Mar, 2033
{"application_id":"75793","ingredient":"BENDAMUSTINE HYDROCHLORIDE","trade_name":"BENDEKA","family_id":"49e9fa2718cf45a1b589","publication_number":"US9597399B2","cleaned_patent_number":"9597399","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-03-15","publication_date":"2017-03-21","legal_status":"Granted"} US9597399B2 21 Mar, 2017 Granted 15 Mar, 2033
{"application_id":"75788","ingredient":"BENDAMUSTINE HYDROCHLORIDE","trade_name":"BENDEKA","family_id":"49e9fa2718cf45a1b589","publication_number":"US9572887B2","cleaned_patent_number":"9572887","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-03-15","publication_date":"2017-02-21","legal_status":"Granted"} US9572887B2 21 Feb, 2017 Granted 15 Mar, 2033
{"application_id":"75790","ingredient":"BENDAMUSTINE HYDROCHLORIDE","trade_name":"BENDEKA","family_id":"49e9fa2718cf45a1b589","publication_number":"US9579384B2","cleaned_patent_number":"9579384","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-03-15","publication_date":"2017-02-28","legal_status":"Granted"} US9579384B2 28 Feb, 2017 Granted 15 Mar, 2033
{"application_id":"100919","ingredient":"BENDAMUSTINE HYDROCHLORIDE","trade_name":"BENDEKA","family_id":"56cee685b56f4d5d9773","publication_number":"DE122009000021I1","cleaned_patent_number":"9000021","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-03-15","publication_date":"2009-08-06","legal_status":"-"} US9000021B2 06 Aug, 2009 - 15 Mar, 2033
{"application_id":"139389","ingredient":"BENDAMUSTINE HYDROCHLORIDE","trade_name":"VIVIMUSTA","family_id":"","publication_number":"US12208086B2","cleaned_patent_number":"12208086","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2042-07-29","publication_date":"2025-01-28","legal_status":"Granted"} US12208086B2 Formulation 28 Jan, 2025 Granted 29 Jul, 2042
{"application_id":"120827","ingredient":"BENDAMUSTINE HYDROCHLORIDE","trade_name":"VIVIMUSTA","family_id":"fbc9621a70e8479ba227","publication_number":"US11844784B2","cleaned_patent_number":"11844784","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2042-07-29","publication_date":"2023-12-19","legal_status":"Granted"} US11844784B2 Formulation 19 Dec, 2023 Granted 29 Jul, 2042

Recent Clinical Trials

Latest clinical trials and research studies for this ingredient

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Note: Patent expirations and exclusivity timelines are dynamic and may shift based on litigation, regulatory extensions, and maintenance filings. Regular monitoring is advised.

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