BUPIVACAINE Drug Patent Profile

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Bupivacaine is a drug marketed by Aspiro, 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-four 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:	12
NDAs:	34
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
Hospira	BUPIVACAINE HYDROCHLORIDE KIT	bupivacaine hydrochloride	INJECTABLE;INJECTION	019978-001	Sep 3, 1992		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Huons	BUPIVACAINE HYDROCHLORIDE	bupivacaine hydrochloride	INJECTABLE;SPINAL	212822-001	Dec 30, 2019	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hikma Pharms	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	bupivacaine hydrochloride	INJECTABLE;INJECTION	204842-003	Feb 11, 2021	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Eugia Pharma	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	bupivacaine hydrochloride	INJECTABLE;INJECTION	203895-002	Nov 5, 2013	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Intl Medicated	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	bupivacaine hydrochloride	INJECTABLE;INJECTION	076012-001	Jan 9, 2002		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Steriscience	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	bupivacaine hydrochloride	INJECTABLE;INJECTION	091487-003	Oct 18, 2011	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