Bupivacaine hydrochloride - Generic Drug Details

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

Bupivacaine hydrochloride is the generic ingredient in thirteen branded drugs marketed by Innocoll Pharms, Civica, Eugia Pharma, Hikma Pharms, Hospira, Kindos, Somerset, Steriscience, Intl Medicated, Fresenius Kabi Usa, B Braun Medical Inc, Baxter Hlthcare Corp, Huons, Septodont, and Amphastar Pharms Inc, and is included in forty-six NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Bupivacaine hydrochloride has seventy-nine patent family members in twenty-three countries.

There are six drug master file entries for bupivacaine hydrochloride. Nineteen suppliers are listed for this compound.

Summary for bupivacaine hydrochloride

International Patents:	79
US Patents:	2
Tradenames:	13
Applicants:	15
NDAs:	46
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	119
Clinical Trials:	1,623
Patent Applications:	1,076
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 Hospital "Sestre Milosrdnice"	N/A
National Trauma Center	N/A
Johnny K. Lee	Phase 4

See all bupivacaine hydrochloride clinical trials

Pharmacology for bupivacaine hydrochloride

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

Anatomical Therapeutic Chemical (ATC) Classes for bupivacaine hydrochloride

N01BB	Amides
N01B	ANESTHETICS, LOCAL
N01	ANESTHETICS
N	Nervous system

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
Steriscience	BUPIVACAINE HYDROCHLORIDE	bupivacaine hydrochloride	INJECTABLE;INJECTION	091503-002	Oct 18, 2011	AP	RX	No	No
Eugia Pharma	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	bupivacaine hydrochloride	INJECTABLE;INJECTION	203895-001	Nov 5, 2013	AP	RX	No	No
Septodont	VIVACAINE	bupivacaine hydrochloride; epinephrine bitartrate	INJECTABLE;INJECTION	077250-001	Sep 27, 2006		RX	No	Yes
B Braun Medical Inc	BUPIVACAINE HYDROCHLORIDE	bupivacaine hydrochloride	INJECTABLE;SPINAL	209087-001	Apr 2, 2019	AP	RX	No	No
Steriscience	BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	bupivacaine hydrochloride	INJECTABLE;INJECTION	091487-001	Oct 18, 2011	AP	RX	No	No
Fresenius Kabi Usa	SENSORCAINE	bupivacaine hydrochloride; epinephrine bitartrate	INJECTABLE;INJECTION	018304-004	Sep 2, 1983	AP	RX	Yes	No
Hospira	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	bupivacaine hydrochloride; epinephrine	INJECTABLE;INJECTION	071169-001	Jun 16, 1988		DISCN	No	No

International Patents for bupivacaine hydrochloride

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1244296	改性膠原 (A MODIFIED COLLAGEN)
Hungary	E037043
Japan	2010522738
Serbia	61726	MODIFIKOVANI KOLAGEN (A MODIFIED COLLAGEN)
Lithuania	3255106
Ireland	20070220	A drug delivery device for providing local analgesia, local anesthesia or nerve blockade
Denmark	2139457