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Bupivacaine hydrochloride - Generic Drug Details

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

Bupivacaine hydrochloride is the generic ingredient in twelve branded drugs marketed by Innocoll Pharms, Aurobindo Pharma Ltd, Hospira, Mylan Asi, Novocol Healthcare, Intl Medicated, Fresenius Kabi Usa, B Braun Medical Inc, Baxter Hlthcare Corp, Huons, Septodont, and Amphastar Pharms Inc, and is included in forty-one NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Bupivacaine hydrochloride has twenty-six patent family members in fifteen countries.

There are twelve drug master file entries for bupivacaine hydrochloride. Thirteen suppliers are listed for this compound.

Summary for bupivacaine hydrochloride

International Patents:	26
US Patents:	1
Tradenames:	12
Applicants:	12
NDAs:	41
Drug Master File Entries:	12
Suppliers / Packagers:	13
Bulk Api Vendors:	94
Clinical Trials:	1,280
Patent Applications:	910
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in bupivacaine hydrochloride?	bupivacaine hydrochloride excipients list
DailyMed Link:	bupivacaine hydrochloride at DailyMed

Recent Clinical Trials for bupivacaine hydrochloride

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

Sponsor	Phase
Laval University	Phase 3
CHU de Quebec-Universite Laval	Phase 3
The Geneva Foundation	N/A

See all bupivacaine hydrochloride clinical trials

Pharmacology for bupivacaine hydrochloride

Drug Class	Amide Local Anesthetic alpha-Adrenergic Agonist beta-Adrenergic Agonist Catecholamine
Mechanism of Action	Adrenergic alpha-Agonists Adrenergic beta-Agonists
Physiological Effect	Local Anesthesia

US Patents and Regulatory Information for bupivacaine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novocol Healthcare	BUPIVACAINE HYDROCHLORIDE	bupivacaine hydrochloride	INJECTABLE;INJECTION	211096-001	Feb 19, 2019		DISCN	No	No
Mylan Asi	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	bupivacaine hydrochloride	INJECTABLE;INJECTION	091487-002	Oct 18, 2011		DISCN	No	No
Hospira	MARCAINE HYDROCHLORIDE	bupivacaine hydrochloride	INJECTABLE;INJECTION	016964-006	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes
Mylan Asi	BUPIVACAINE HYDROCHLORIDE	bupivacaine hydrochloride	INJECTABLE;INJECTION	091503-002	Oct 18, 2011		DISCN	No	No
Fresenius Kabi Usa	SENSORCAINE	bupivacaine hydrochloride; epinephrine bitartrate	INJECTABLE;INJECTION	070967-001	Oct 13, 1987	AP	RX	No	No
Hospira	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE	bupivacaine hydrochloride; epinephrine bitartrate	INJECTABLE;INJECTION	016964-008	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes

International Patents for bupivacaine hydrochloride

Country	Patent Number	Estimated Expiration
Japan	2010522738
World Intellectual Property Organization (WIPO)	2008117268
Ireland	S20080229
Ireland	20070220
Hungary	E043185
Portugal	3085363