BUPIVACAINE Drug Patent Profile

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Bupivacaine is a drug marketed by Civica, Eugia Pharma, Hikma Pharms, Hospira, Kindos, Somerset, Steriscience, B Braun Medical Inc, Baxter Hlthcare Corp, Huons, and Intl Medicated. and is included in thirty-three NDAs.

The generic ingredient in BUPIVACAINE is bupivacaine hydrochloride; epinephrine bitartrate. There are twelve drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the bupivacaine hydrochloride; epinephrine bitartrate profile page.

US Patents:	0
Applicants:	11
NDAs:	33
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for BUPIVACAINE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BUPIVACAINE
DailyMed Link:	BUPIVACAINE at DailyMed

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

Anesthetics, Local

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

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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
Eugia Pharma	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	bupivacaine hydrochloride	INJECTABLE;INJECTION	203895-001	Nov 5, 2013	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hospira	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	bupivacaine hydrochloride; epinephrine	INJECTABLE;INJECTION	071167-001	Jun 16, 1988		RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Intl Medicated	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	bupivacaine hydrochloride	INJECTABLE;INJECTION	076012-003	Jan 9, 2002		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hikma Pharms	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	bupivacaine hydrochloride	INJECTABLE;INJECTION	204842-002	Feb 11, 2021	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Steriscience	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	bupivacaine hydrochloride	INJECTABLE;INJECTION	091487-002	Oct 18, 2011	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hospira	BUPIVACAINE HYDROCHLORIDE	bupivacaine hydrochloride	INJECTABLE;SPINAL	071810-001	Dec 11, 1987	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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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