Bupivacaine hydrochloride - Generic Drug Details

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, Civica, Eugia Pharma, Hikma Pharms, Hospira, Steriscience, Intl Medicated, Fresenius Kabi Usa, B Braun Medical Inc, Baxter Hlthcare Corp, Huons, Septodont, and Amphastar Pharms Inc, and is included in forty-three 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 six drug master file entries for bupivacaine hydrochloride. Sixteen suppliers are listed for this compound.

Summary for bupivacaine hydrochloride

International Patents:	26
US Patents:	1
Tradenames:	12
Applicants:	13
NDAs:	43
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	106
Clinical Trials:	1,543
Patent Applications:	987
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
University of Seville	Phase 4
Nottingham University Hospitals NHS Trust	N/A
Aalborg University	N/A

See all bupivacaine hydrochloride clinical trials

Pharmacology for bupivacaine hydrochloride

Drug Class	Amide Local Anesthetic Amide Local Anesthetic Catecholamine alpha-Adrenergic Agonist beta-Adrenergic Agonist
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
Fresenius Kabi Usa	SENSORCAINE	bupivacaine hydrochloride	INJECTABLE;INJECTION	018304-003	Approved Prior to Jan 1, 1982	AP	RX	No	No
Fresenius Kabi Usa	SENSORCAINE	bupivacaine hydrochloride; epinephrine bitartrate	INJECTABLE;INJECTION	070966-001	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
Fresenius Kabi Usa	SENSORCAINE	bupivacaine hydrochloride; epinephrine bitartrate	INJECTABLE;INJECTION	070967-001	Oct 13, 1987	AP	RX	No	No
Hospira	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE	bupivacaine hydrochloride; epinephrine bitartrate	INJECTABLE;INJECTION	016964-010	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes
Hospira	BUPIVACAINE HYDROCHLORIDE	bupivacaine hydrochloride	INJECTABLE;INJECTION	070585-001	Mar 3, 1987	AP	RX	No	No

International Patents for bupivacaine hydrochloride

Country	Patent Number	Title	Estimated Expiration
Ireland	20070220	A drug delivery device for providing local analgesia, local anesthesia or nerve blockade
Japan	5372905
Cyprus	1117814
Slovenia	3085363
Slovenia	2139457
Poland	2139457