Bupivacaine - Generic Drug Details

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What are the generic sources for bupivacaine and what is the scope of patent protection?

Bupivacaine is the generic ingredient in seventeen branded drugs marketed by Hengrui Pharma, Pacira Pharms Inc, Innocoll, Innocoll Pharms, Aspiro, Civica, Eugia Pharma, Hikma Pharms, Hospira, Meitheal, Somerset, Steriscience Speclts, Intl Medicated, Fresenius Kabi Usa, B Braun Medical Inc, Baxter Hlthcare Corp, Huons, Septodont, Amphastar Pharms Inc, and Heron Theraps Inc, and is included in fifty-one NDAs. There are thirty-seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Bupivacaine has sixty-nine patent family members in thirty countries.

There are twelve drug master file entries for bupivacaine. Two suppliers are listed for this compound.

Summary for bupivacaine

International Patents:	69
US Patents:	37
Tradenames:	17
Applicants:	20
NDAs:	51
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	125
Clinical Trials:	1,674
Patent Applications:	6,961
Drug Prices:	Drug price trends for bupivacaine
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for bupivacaine
What excipients (inactive ingredients) are in bupivacaine?	bupivacaine excipients list
DailyMed Link:	bupivacaine at DailyMed

See drug prices for bupivacaine

Recent Clinical Trials for bupivacaine

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Yongtao Sun	Phase 4
Montefiore Medical Center	N/A
University Hospital "Sestre Milosrdnice"	N/A

See all bupivacaine clinical trials

Pharmacology for bupivacaine

Drug Class	Amide Local Anesthetic
Physiological Effect	Local Anesthesia

Medical Subject Heading (MeSH) Categories for bupivacaine

Anesthetics, Local

Anatomical Therapeutic Chemical (ATC) Classes for bupivacaine

N01BB	Amides
N01B	ANESTHETICS, LOCAL
N01	ANESTHETICS
N	Nervous system

Paragraph IV (Patent) Challenges for BUPIVACAINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EXPAREL	Injectable Suspension	bupivacaine	133 mg/10 mL	022496	1	2021-12-28
EXPAREL	Injectable Suspension	bupivacaine	266 mg/20 mL	022496	1	2021-08-20

US Patents and Regulatory Information for bupivacaine

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Steriscience Speclts	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	bupivacaine hydrochloride	INJECTABLE;INJECTION	091487-002	Oct 18, 2011	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hospira	MARCAINE HYDROCHLORIDE	bupivacaine hydrochloride	INJECTABLE;INJECTION	016964-006	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Eugia Pharma	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	bupivacaine hydrochloride	INJECTABLE;INJECTION	203895-003	Nov 5, 2013	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hospira	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	bupivacaine hydrochloride; epinephrine	INJECTABLE;INJECTION	071166-001	Jun 16, 1988		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Heron Theraps Inc	ZYNRELEF KIT	bupivacaine; meloxicam	SOLUTION, EXTENDED RELEASE;PERIARTICULAR	211988-002	May 12, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-001	Oct 28, 2011	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Fresenius Kabi Usa	SENSORCAINE	bupivacaine hydrochloride; epinephrine bitartrate	INJECTABLE;INJECTION	018304-004	Sep 2, 1983	AP	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for bupivacaine

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-002	Oct 28, 2011	⤷ Sign Up	⤷ Sign Up
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-002	Oct 28, 2011	⤷ Sign Up	⤷ Sign Up
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-001	Oct 28, 2011	⤷ Sign Up	⤷ Sign Up
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-001	Oct 28, 2011	⤷ Sign Up	⤷ Sign Up
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-002	Oct 28, 2011	⤷ Sign Up	⤷ Sign Up
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-001	Oct 28, 2011	⤷ Sign Up	⤷ Sign Up
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-002	Oct 28, 2011	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for bupivacaine

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pacira Ireland Limited	Exparel liposomal	bupivacaine	EMEA/H/C/004586 Exparel liposomal is indicated:in adults as a brachial plexus block or femoral nerve block for treatment of post-operative pain.in adults and children aged 6 years or older as a field block for treatment of somatic post-operative pain from small- to medium-sized surgical wounds.	Authorised	no	no	no	2020-11-16
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for bupivacaine

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Country	Patent Number	Title	Estimated Expiration
Poland	2415484		⤷ Sign Up
Denmark	1809329		⤷ Sign Up
South Africa	200702373	Sustained local anesthetic composition containing preferably a sugar ester such as saib	⤷ Sign Up
Brazil	PI0515372	composição, e, método para fornecer um efeito anestésico a um sìtio em um indivìduo	⤷ Sign Up
Israel	181474	מערכת למתן מבוקר (Controlled delivery system)	⤷ Sign Up
European Patent Office	1809329	COMPOSITION LOCALE ANESTHESIQUE A DELIVRANCE SOUTENUE CONTENANT AIBS (SUSTAINED LOCAL ANESTHETIC COMPOSITION CONTAINING SAIB)	⤷ Sign Up
Brazil	112022013784	SISTEMAS DE DISTRIBUIÇÃO DE FÁRMACOS DE LIBERAÇÃO PROLONGADA COM IMPUREZAS REDUZIDAS E MÉTODOS RELACIONADOS	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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