BUPIVACAINE - Generic Drug Details

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

Bupivacaine is the generic ingredient in sixteen branded drugs marketed by Pacira Pharms Inc, Innocoll, Innocoll Pharms, Civica, Eugia Pharma, Hikma Pharms, Hospira, Kindos, Somerset, Steriscience, 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 forty-nine NDAs. There are thirty-four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Bupivacaine has sixty-eight 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:	68
US Patents:	34
Tradenames:	16
Applicants:	18
NDAs:	49
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	125
Clinical Trials:	1,623
Patent Applications:	6,961
Formulation / Manufacturing:	see details
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for BUPIVACAINE

Constraining patent/regulatory exclusivity:

INDICATED TO PRODUCE POSTSURGICAL REGIONAL ANALGESIA IN ADULTS VIA ASCIATIC NERVE BLOCK IN THE POPLITEAL FOSSA AND VIA AN ADDUCTOR CANAL BLOCK

Dosage:

INJECTABLE, LIPOSOMAL;INJECTION

Dosage:

SOLUTION, EXTENDED RELEASE;INFILTRATION

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for BUPIVACAINE

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

Sponsor	Phase
University Hospital "Sestre Milosrdnice"	N/A
National Trauma Center	N/A
Johnny K. Lee	Phase 4

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

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Innocoll Pharms	XARACOLL	bupivacaine hydrochloride	IMPLANT;IMPLANTATION	209511-001	Aug 28, 2020		RX	Yes	Yes			Y
Hospira	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE	bupivacaine hydrochloride; epinephrine bitartrate	INJECTABLE;INJECTION	016964-013	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes
Hospira	MARCAINE HYDROCHLORIDE PRESERVATIVE FREE	bupivacaine hydrochloride	INJECTABLE;INJECTION	016964-005	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes
Heron Theraps Inc	ZYNRELEF KIT	bupivacaine; meloxicam	SOLUTION, EXTENDED RELEASE;PERIARTICULAR	211988-001	May 12, 2021		DISCN	Yes	No			Y
Heron Theraps Inc	ZYNRELEF KIT	bupivacaine; meloxicam	SOLUTION, EXTENDED RELEASE;PERIARTICULAR	211988-001	May 12, 2021		DISCN	Yes	No
Heron Theraps Inc	ZYNRELEF KIT	bupivacaine; meloxicam	SOLUTION, EXTENDED RELEASE;PERIARTICULAR	211988-003	May 12, 2021		DISCN	Yes	No			Y
Hikma Pharms	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	bupivacaine hydrochloride	INJECTABLE;INJECTION	204842-001	Feb 11, 2021	AP	RX	No	No

Expired US Patents for BUPIVACAINE

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
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-001	Oct 28, 2011
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-002	Oct 28, 2011
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-001	Oct 28, 2011
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-002	Oct 28, 2011
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-001	Oct 28, 2011
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-002	Oct 28, 2011

EU/EMA Drug Approvals for BUPIVACAINE

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

International Patents for BUPIVACAINE

Country	Patent Number	Title	Estimated Expiration
Cyprus	1118360
Georgia, Republic of	P20094831	CONTROL RELEASE SYSTEM
Israel	181474	מערכת למתן מבוקר (Controlled delivery system)
Slovenia	2767292
South Africa	200702373	Sustained local anesthetic composition containing preferably a sugar ester such as saib
European Patent Office	4090353	SYSTÈMES D'ADMINISTRATION DE MÉDICAMENT À LIBÉRATION PROLONGÉE AVEC IMPURETÉS RÉDUITES ET PROCÉDÉS ASSOCIÉS (SUSTAINED RELEASE DRUG DELIVERY SYSTEMS WITH REDUCED IMPURITIES AND RELATED METHODS)
Russian Federation	2429882	СИСТЕМА КОНТРОЛИРУЕМОЙ ДОСТАВКИ (CONTROLLED DELIVERY SYSTEM)