BUPIVACAINE HYDROCHLORIDE Drug Patent Profile

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

The generic ingredient in BUPIVACAINE HYDROCHLORIDE 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
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	119
Clinical Trials:	1,674
Patent Applications:	753
DailyMed Link:	BUPIVACAINE HYDROCHLORIDE at DailyMed

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

Drug Class	Amide Local Anesthetic
Physiological Effect	Local Anesthesia

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Huons	BUPIVACAINE HYDROCHLORIDE	bupivacaine hydrochloride	INJECTABLE;SPINAL	212822-001	Dec 30, 2019	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma Pharms	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	bupivacaine hydrochloride	INJECTABLE;INJECTION	204842-003	Feb 11, 2021	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Eugia Pharma	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	bupivacaine hydrochloride	INJECTABLE;INJECTION	203895-002	Nov 5, 2013	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Intl Medicated	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	bupivacaine hydrochloride	INJECTABLE;INJECTION	076012-001	Jan 9, 2002		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Steriscience Speclts	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	bupivacaine hydrochloride	INJECTABLE;INJECTION	091487-003	Oct 18, 2011	AP	RX	No	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