Bupivacaine hydrochloride; epinephrine bitartrate - Generic Drug Details

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

Bupivacaine hydrochloride; epinephrine bitartrate is the generic ingredient in five branded drugs marketed by Hospira, Fresenius Kabi Usa, and Septodont, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

Six suppliers are listed for this compound.

Summary for bupivacaine hydrochloride; epinephrine bitartrate

US Patents:	0
Tradenames:	5
Applicants:	3
NDAs:	7
Finished Product Suppliers / Packagers:	6
Clinical Trials:	2
DailyMed Link:	bupivacaine hydrochloride; epinephrine bitartrate at DailyMed

Recent Clinical Trials for bupivacaine hydrochloride; epinephrine bitartrate

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

Sponsor	Phase
Sunnybrook Health Sciences Centre	N/A
Cosmozone Dental Clinic	N/A

See all bupivacaine hydrochloride; epinephrine bitartrate clinical trials

Pharmacology for bupivacaine hydrochloride; epinephrine bitartrate

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; epinephrine bitartrate

A01AD	Other agents for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

B02BC	Local hemostatics
B02B	VITAMIN K AND OTHER HEMOSTATICS
B02	ANTIHEMORRHAGICS
B	Blood and blood forming organs

C01CA	Adrenergic and dopaminergic agents
C01C	CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES
C01	CARDIAC THERAPY
C	Cardiovascular system

N01BB	Amides
N01B	ANESTHETICS, LOCAL
N01	ANESTHETICS
N	Nervous system

R01AA	Sympathomimetics, plain
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R03AA	Alpha- and beta-adrenoreceptor agonists
R03A	ADRENERGICS, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

S01EA	Sympathomimetics in glaucoma therapy
S01E	ANTIGLAUCOMA PREPARATIONS AND MIOTICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for bupivacaine hydrochloride; epinephrine bitartrate

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; epinephrine bitartrate	INJECTABLE;INJECTION	018304-005	Sep 2, 1983	AP	RX	Yes	No
Hospira	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE	bupivacaine hydrochloride; epinephrine bitartrate	INJECTABLE;INJECTION	016964-013	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes
Fresenius Kabi Usa	SENSORCAINE	bupivacaine hydrochloride; epinephrine bitartrate	INJECTABLE;INJECTION	070968-001	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	MARCAINE HYDROCHLORIDE W/ EPINEPHRINE	bupivacaine hydrochloride; epinephrine bitartrate	INJECTABLE;INJECTION	016964-004	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes