Bupivacaine Global Patent Coverage & Expiry Overview

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It is formulated by 15 pharmaceutical companies such as ONESOURCE SPECIALTY, PACIRA PHARMS INC, EUGIA PHARMA and others. It is marketed under 7 brand names, including BUPIVACAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE, EXPAREL and others. Available in 11 different strengths, such as 0.25%, 0.75%, 0.5% and others, and administered through 6 routes including INJECTABLE;INJECTION, INJECTABLE, LIPOSOMAL;INJECTION, INJECTABLE;SPINAL and others.

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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

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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":"70065","ingredient":"BUPIVACAINE","trade_name":"POSIMIR","family_id":"4a74dbd328be465cb607","publication_number":"US8153149B2","cleaned_patent_number":"8153149","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-09-15","publication_date":"2012-04-10","legal_status":"Granted"}	US8153149B2 Formulation	10 Apr, 2012	Granted	15 Sep, 2025
{"application_id":"70019","ingredient":"BUPIVACAINE","trade_name":"POSIMIR","family_id":"4a74dbd328be465cb607","publication_number":"US8753665B2","cleaned_patent_number":"8753665","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-09-15","publication_date":"2014-06-17","legal_status":"Granted"}	US8753665B2 Formulation	17 Jun, 2014	Granted	15 Sep, 2025
{"application_id":"70066","ingredient":"BUPIVACAINE","trade_name":"POSIMIR","family_id":"4a74dbd328be465cb607","publication_number":"US8153661B2","cleaned_patent_number":"8153661","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-09-15","publication_date":"2012-04-10","legal_status":"Granted"}	US8153661B2	10 Apr, 2012	Granted	15 Sep, 2025
{"application_id":"70067","ingredient":"BUPIVACAINE","trade_name":"POSIMIR","family_id":"4a74dbd328be465cb607","publication_number":"US8846072B2","cleaned_patent_number":"8846072","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-09-15","publication_date":"2014-09-30","legal_status":"Granted"}	US8846072B2 Formulation	30 Sep, 2014	Granted	15 Sep, 2025
{"application_id":"60698","ingredient":"BUPIVACAINE HYDROCHLORIDE","trade_name":"XARACOLL","family_id":"6b672314795c42a4a674","publication_number":"USRE47826E1","cleaned_patent_number":"RE47826","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-05-20","publication_date":"2020-01-28","legal_status":"Patented case"}	USRE47826E1	28 Jan, 2020	Patented case	20 May, 2029
{"application_id":"115162","ingredient":"BUPIVACAINE HYDROCHLORIDE","trade_name":"XARACOLL","family_id":"26d76242c027400f8ac0","publication_number":"US11746141B2","cleaned_patent_number":"11746141","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-01-09","publication_date":"2023-09-05","legal_status":"Granted"}	US11746141B2 Formulation	05 Sep, 2023	Granted	09 Jan, 2033
{"application_id":"70099","ingredient":"BUPIVACAINE; MELOXICAM","trade_name":"ZYNRELEF KIT","family_id":"83087589eee04370b1a2","publication_number":"US11253504B2","cleaned_patent_number":"11253504","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-03-13","publication_date":"2022-02-22","legal_status":"Granted"}	US11253504B2	22 Feb, 2022	Granted	13 Mar, 2034
{"application_id":"70079","ingredient":"BUPIVACAINE; MELOXICAM","trade_name":"ZYNRELEF KIT","family_id":"83087589eee04370b1a2","publication_number":"US9592227B2","cleaned_patent_number":"9592227","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-03-13","publication_date":"2017-03-14","legal_status":"Granted"}	US9592227B2 Formulation	14 Mar, 2017	Granted	13 Mar, 2034
{"application_id":"70098","ingredient":"BUPIVACAINE; MELOXICAM","trade_name":"ZYNRELEF KIT","family_id":"83087589eee04370b1a2","publication_number":"US10398686B2","cleaned_patent_number":"10398686","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-03-13","publication_date":"2019-09-03","legal_status":"Granted"}	US10398686B2 Formulation	03 Sep, 2019	Granted	13 Mar, 2034
{"application_id":"70097","ingredient":"BUPIVACAINE; MELOXICAM","trade_name":"ZYNRELEF KIT","family_id":"83087589eee04370b1a2","publication_number":"US9913909B2","cleaned_patent_number":"9913909","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-03-13","publication_date":"2018-03-13","legal_status":"Granted"}	US9913909B2	13 Mar, 2018	Granted	13 Mar, 2034
{"application_id":"70096","ingredient":"BUPIVACAINE; MELOXICAM","trade_name":"ZYNRELEF KIT","family_id":"83087589eee04370b1a2","publication_number":"US9744163B2","cleaned_patent_number":"9744163","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-03-13","publication_date":"2017-08-29","legal_status":"Granted"}	US9744163B2 Formulation	29 Aug, 2017	Granted	13 Mar, 2034
{"application_id":"70145","ingredient":"BUPIVACAINE; MELOXICAM","trade_name":"ZYNRELEF KIT","family_id":"3ce178a6de7f477580d4","publication_number":"US10980886B2","cleaned_patent_number":"10980886","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-04-20","publication_date":"2021-04-20","legal_status":"Granted"}	US10980886B2 Formulation	20 Apr, 2021	Granted	20 Apr, 2035
{"application_id":"70133","ingredient":"BUPIVACAINE; MELOXICAM","trade_name":"ZYNRELEF KIT","family_id":"439003515b5d4682bc80","publication_number":"US10213510B2","cleaned_patent_number":"10213510","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-04-20","publication_date":"2019-02-26","legal_status":"Granted"}	US10213510B2 Formulation	26 Feb, 2019	Granted	20 Apr, 2035
{"application_id":"70134","ingredient":"BUPIVACAINE; MELOXICAM","trade_name":"ZYNRELEF KIT","family_id":"439003515b5d4682bc80","publication_number":"US10632199B2","cleaned_patent_number":"10632199","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-04-20","publication_date":"2020-04-28","legal_status":"Granted"}	US10632199B2 Formulation	28 Apr, 2020	Granted	20 Apr, 2035
{"application_id":"70135","ingredient":"BUPIVACAINE; MELOXICAM","trade_name":"ZYNRELEF KIT","family_id":"439003515b5d4682bc80","publication_number":"US10898575B2","cleaned_patent_number":"10898575","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-04-20","publication_date":"2021-01-26","legal_status":"Granted"}	US10898575B2 Formulation	26 Jan, 2021	Granted	20 Apr, 2035
{"application_id":"70132","ingredient":"BUPIVACAINE; MELOXICAM","trade_name":"ZYNRELEF KIT","family_id":"439003515b5d4682bc80","publication_number":"US10098957B2","cleaned_patent_number":"10098957","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-04-20","publication_date":"2018-10-16","legal_status":"Granted"}	US10098957B2	16 Oct, 2018	Granted	20 Apr, 2035
{"application_id":"70136","ingredient":"BUPIVACAINE; MELOXICAM","trade_name":"ZYNRELEF KIT","family_id":"439003515b5d4682bc80","publication_number":"US11083730B2","cleaned_patent_number":"11083730","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-04-20","publication_date":"2021-08-10","legal_status":"Granted"}	US11083730B2 Formulation	10 Aug, 2021	Granted	20 Apr, 2035
{"application_id":"70137","ingredient":"BUPIVACAINE; MELOXICAM","trade_name":"ZYNRELEF KIT","family_id":"439003515b5d4682bc80","publication_number":"US11083797B2","cleaned_patent_number":"11083797","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-04-20","publication_date":"2021-08-10","legal_status":"Granted"}	US11083797B2 Formulation	10 Aug, 2021	Granted	20 Apr, 2035
{"application_id":"70138","ingredient":"BUPIVACAINE; MELOXICAM","trade_name":"ZYNRELEF KIT","family_id":"5db676e311914aa59da9","publication_number":"US11413350B2","cleaned_patent_number":"11413350","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-04-20","publication_date":"2022-08-16","legal_status":"Granted"}	US11413350B2	16 Aug, 2022	Granted	20 Apr, 2035
{"application_id":"70103","ingredient":"BUPIVACAINE; MELOXICAM","trade_name":"ZYNRELEF KIT","family_id":"439003515b5d4682bc80","publication_number":"US9694079B2","cleaned_patent_number":"9694079","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-04-20","publication_date":"2017-07-04","legal_status":"Granted"}	US9694079B2 Formulation	04 Jul, 2017	Granted	20 Apr, 2035
{"application_id":"70131","ingredient":"BUPIVACAINE; MELOXICAM","trade_name":"ZYNRELEF KIT","family_id":"439003515b5d4682bc80","publication_number":"US9801945B2","cleaned_patent_number":"9801945","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-04-20","publication_date":"2017-10-31","legal_status":"Granted"}	US9801945B2 Formulation	31 Oct, 2017	Granted	20 Apr, 2035
{"application_id":"70161","ingredient":"BUPIVACAINE; MELOXICAM","trade_name":"ZYNRELEF KIT","family_id":"3ce178a6de7f477580d4","publication_number":"US11844837B2","cleaned_patent_number":"11844837","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-04-21","publication_date":"2023-12-19","legal_status":"Granted"}	US11844837B2	19 Dec, 2023	Granted	21 Apr, 2036
{"application_id":"105551","ingredient":"BUPIVACAINE","trade_name":"POSIMIR","family_id":"2420c5605c6747a7b790","publication_number":"US11400019B2","cleaned_patent_number":"11400019","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-01-12","publication_date":"2022-08-02","legal_status":"Granted"}	US11400019B2 Formulation	02 Aug, 2022	Granted	12 Jan, 2041
{"application_id":"117472","ingredient":"BUPIVACAINE","trade_name":"POSIMIR","family_id":"05b11d97e1c046f7ad4d","publication_number":"US11771624B2","cleaned_patent_number":"11771624","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-01-12","publication_date":"2023-10-03","legal_status":"Granted"}	US11771624B2	03 Oct, 2023	Granted	12 Jan, 2041
{"application_id":"117835","ingredient":"BUPIVACAINE","trade_name":"EXPAREL","family_id":"e9523a25f9c3421ea075","publication_number":"US2023301916A1","cleaned_patent_number":"12144890","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-01-22","publication_date":"2024-11-19","legal_status":"Granted"}	US12144890B2 Formulation	19 Nov, 2024	Granted	22 Jan, 2041
{"application_id":"117832","ingredient":"BUPIVACAINE","trade_name":"EXPAREL","family_id":"e9523a25f9c3421ea075","publication_number":"US2022304932A1","cleaned_patent_number":"12151024","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-01-22","publication_date":"2024-11-26","legal_status":"Granted"}	US12151024B2 Formulation	26 Nov, 2024	Granted	22 Jan, 2041
{"application_id":"179154","ingredient":"BUPIVACAINE","trade_name":"EXPAREL","family_id":"e9523a25f9c3421ea075","publication_number":"US12296047B2","cleaned_patent_number":"12296047","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-01-22","publication_date":"2025-05-13","legal_status":"Granted"}	US12296047B2 Formulation	13 May, 2025	Granted	22 Jan, 2041
{"application_id":"61342","ingredient":"BUPIVACAINE","trade_name":"EXPAREL","family_id":"e9523a25f9c3421ea075","publication_number":"US11819575B2","cleaned_patent_number":"11819575","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-01-22","publication_date":"2023-11-21","legal_status":"Granted"}	US11819575B2 Formulation	21 Nov, 2023	Granted	22 Jan, 2041
{"application_id":"117834","ingredient":"BUPIVACAINE","trade_name":"EXPAREL","family_id":"e9523a25f9c3421ea075","publication_number":"US11925706B2","cleaned_patent_number":"11925706","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-01-22","publication_date":"2024-03-12","legal_status":"Granted"}	US11925706B2 Formulation	12 Mar, 2024	Granted	22 Jan, 2041
{"application_id":"61339","ingredient":"BUPIVACAINE","trade_name":"EXPAREL","family_id":"e9523a25f9c3421ea075","publication_number":"US11311486B1","cleaned_patent_number":"11311486","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-01-22","publication_date":"2022-04-26","legal_status":"Granted"}	US11311486B2 Formulation	26 Apr, 2022	Granted	22 Jan, 2041
{"application_id":"61338","ingredient":"BUPIVACAINE","trade_name":"EXPAREL","family_id":"e9523a25f9c3421ea075","publication_number":"US11304904B1","cleaned_patent_number":"11304904","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-01-22","publication_date":"2022-04-19","legal_status":"Patented case"}	US11304904B2 Formulation	19 Apr, 2022	Patented case	22 Jan, 2041
{"application_id":"61335","ingredient":"BUPIVACAINE","trade_name":"EXPAREL","family_id":"e9523a25f9c3421ea075","publication_number":"US11179336B1","cleaned_patent_number":"11179336","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-01-22","publication_date":"2021-11-23","legal_status":"Granted"}	US11179336B2 Formulation	23 Nov, 2021	Granted	22 Jan, 2041
{"application_id":"61337","ingredient":"BUPIVACAINE","trade_name":"EXPAREL","family_id":"e9523a25f9c3421ea075","publication_number":"US11278494B1","cleaned_patent_number":"11278494","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-01-22","publication_date":"2022-03-22","legal_status":"Granted"}	US11278494B2 Formulation	22 Mar, 2022	Granted	22 Jan, 2041
{"application_id":"61331","ingredient":"BUPIVACAINE","trade_name":"EXPAREL","family_id":"e9523a25f9c3421ea075","publication_number":"US11033495B1","cleaned_patent_number":"11033495","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-01-22","publication_date":"2021-06-15","legal_status":"Granted"}	US11033495B2 Formulation	15 Jun, 2021	Granted	22 Jan, 2041
{"application_id":"108080","ingredient":"BUPIVACAINE","trade_name":"EXPAREL","family_id":"e9523a25f9c3421ea075","publication_number":"US11452691B2","cleaned_patent_number":"11452691","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-01-22","publication_date":"2022-09-27","legal_status":"Patented case"}	US11452691B2 Formulation	27 Sep, 2022	Patented case	22 Jan, 2041
{"application_id":"61341","ingredient":"BUPIVACAINE","trade_name":"EXPAREL","family_id":"e9523a25f9c3421ea075","publication_number":"US11819574B2","cleaned_patent_number":"11819574","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-01-22","publication_date":"2023-11-21","legal_status":"Granted"}	US11819574B2 Formulation	21 Nov, 2023	Granted	22 Jan, 2041
{"application_id":"61340","ingredient":"BUPIVACAINE","trade_name":"EXPAREL","family_id":"e9523a25f9c3421ea075","publication_number":"US11426348B2","cleaned_patent_number":"11426348","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-01-22","publication_date":"2022-08-30","legal_status":"Granted"}	US11426348B2 Formulation	30 Aug, 2022	Granted	22 Jan, 2041
{"application_id":"61344","ingredient":"BUPIVACAINE","trade_name":"EXPAREL","family_id":"8afbeda9596c46dcbc07","publication_number":"US11357727B1","cleaned_patent_number":"11357727","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-01-22","publication_date":"2022-06-14","legal_status":"Granted"}	US11357727B2 Formulation	14 Jun, 2022	Granted	22 Jan, 2041
{"application_id":"122894","ingredient":"BUPIVACAINE","trade_name":"EXPAREL","family_id":"","publication_number":"US11931459B2","cleaned_patent_number":"11931459","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2042-03-17","publication_date":"2024-03-19","legal_status":"Granted"}	US11931459B2	19 Mar, 2024	Granted	17 Mar, 2042
{"application_id":"164422","ingredient":"BUPIVACAINE","trade_name":"EXPAREL","family_id":"","publication_number":"US12226610B2","cleaned_patent_number":"12226610","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2043-02-02","publication_date":"2025-02-18","legal_status":"Granted"}	US12226610B2	18 Feb, 2025	Granted	02 Feb, 2043
{"application_id":"122895","ingredient":"BUPIVACAINE","trade_name":"EXPAREL","family_id":"","publication_number":"US11918565B1","cleaned_patent_number":"11918565","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2043-02-02","publication_date":"2024-03-05","legal_status":"Granted"}	US11918565B2	05 Mar, 2024	Granted	02 Feb, 2043
{"application_id":"138480","ingredient":"BUPIVACAINE","trade_name":"EXPAREL","family_id":"","publication_number":"US12156940B1","cleaned_patent_number":"12156940","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2044-07-02","publication_date":"2024-12-03","legal_status":"Granted"}	US12156940B2 Formulation	03 Dec, 2024	Granted	02 Jul, 2044
{"application_id":"164423","ingredient":"BUPIVACAINE","trade_name":"EXPAREL","family_id":"","publication_number":"US12251468B1","cleaned_patent_number":"12251468","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2044-07-02","publication_date":"2025-03-18","legal_status":"Patented Case"}	US12251468B2 Formulation	18 Mar, 2025	Patented Case	02 Jul, 2044
{"application_id":"242107","ingredient":"BUPIVACAINE","trade_name":"EXPAREL","family_id":"","publication_number":"US12318483B1","cleaned_patent_number":"12318483","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2044-07-02","publication_date":"2025-06-03","legal_status":"Granted"}	US12318483B2	03 Jun, 2025	Granted	02 Jul, 2044

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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.