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 fifteen branded drugs marketed by Pacira Pharms Inc, Innocoll, Innocoll Pharms, Civica, Eugia Pharma, Hikma Pharms, Hospira, 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-six NDAs. There are twenty-nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Bupivacaine has sixty-one 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:	61
US Patents:	29
Tradenames:	15
Applicants:	16
NDAs:	46
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	112
Clinical Trials:	1,535
Patent Applications:	6,941
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

Recent Clinical Trials for bupivacaine

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

Sponsor	Phase
University of Nottingham	N/A
Wake Forest University Health Sciences	Phase 1
Kansas City Heart Rhythm Research Foundation	Phase 1

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
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-002	Oct 28, 2011		RX	Yes	Yes			Y
Eugia Pharma	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	bupivacaine hydrochloride	INJECTABLE;INJECTION	203895-002	Nov 5, 2013	AP	RX	No	No
Steriscience	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	bupivacaine hydrochloride	INJECTABLE;INJECTION	091487-003	Oct 18, 2011		DISCN	No	No
Hospira	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	bupivacaine hydrochloride; epinephrine bitartrate	INJECTABLE;INJECTION	022046-001	Jul 13, 1983		DISCN	Yes	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	022496-001	Oct 28, 2011
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-002	Oct 28, 2011
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-002	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 (see section 5.1):• 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	1112625
Norway	20071914
Canada	3167217	SYSTEMES D'ADMINISTRATION DE MEDICAMENT A LIBERATION PROLONGEE AVEC IMPURETES REDUITES ET PROCEDES ASSOCIES (SUSTAINED RELEASE DRUG DELIVERY SYSTEMS WITH REDUCED IMPURITIES AND RELATED METHODS)
Serbia	52198	RASTVOR LOKALNOG ANESTETIKA KOJI SADRŽI SAIB SA ODRŽIVIM DELOVANJEM (SUSTAINED LOCAL ANESTHETIC COMPOSITION CONTAINING SAIB)