EPINEPHRINE; LIDOCAINE HYDROCHLORIDE - Generic Drug Details

What are the generic sources for epinephrine; lidocaine hydrochloride and what is the scope of freedom to operate?

Epinephrine; lidocaine hydrochloride is the generic ingredient in nine branded drugs marketed by Carlisle, B Braun Medical Inc, Belmora Llc, Eastman Kodak, Hospira, West-ward Pharms Int, Abbott, Bel Mar, Dell Labs, Intl Medication, Watson Labs, Pharmaton, Septodont, Dentsply Pharm, Astrazeneca, Fresenius Kabi Usa, Vyteris, Iomed, and Empi, and is included in thirty-two NDAs. Additional information is available in the individual branded drug profile pages.

Eleven suppliers are listed for this compound.

Summary for EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

US Patents:	0
Tradenames:	9
Applicants:	19
NDAs:	32
Finished Product Suppliers / Packagers:	11
Clinical Trials:	225
DailyMed Link:	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

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

Sponsor	Phase
Montefiore Medical Center	N/A
Jessyka Lighthall	Phase 3
Assiut University	N/A

See all EPINEPHRINE; LIDOCAINE HYDROCHLORIDE clinical trials

Pharmacology for EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

Drug Class	Amide Local Anesthetic Antiarrhythmic 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 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

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

C01BB	Antiarrhythmics, class Ib
C01B	ANTIARRHYTHMICS, CLASS I AND III
C01	CARDIAC THERAPY
C	Cardiovascular system

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

C05AD	Local anesthetics
C05A	AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05	VASOPROTECTIVES
C	Cardiovascular system

D04AB	Anesthetics for topical use
D04A	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D04	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D	Dermatologicals

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

R02AD	Anesthetics, local
R02A	THROAT PREPARATIONS
R02	THROAT 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

S01HA	Local anesthetics
S01H	LOCAL ANESTHETICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

S02DA	Analgesics and anesthetics
S02D	OTHER OTOLOGICALS
S02	OTOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hospira	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	epinephrine; lidocaine hydrochloride	INJECTABLE;INJECTION	088571-001	Sep 13, 1985	AP	RX	No	No
Fresenius Kabi Usa	XYLOCAINE W/ EPINEPHRINE	epinephrine; lidocaine hydrochloride	INJECTABLE;INJECTION	006488-003	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Fresenius Kabi Usa	XYLOCAINE W/ EPINEPHRINE	epinephrine; lidocaine hydrochloride	INJECTABLE;INJECTION	006488-004	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes
Hospira	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	epinephrine; lidocaine hydrochloride	INJECTABLE;INJECTION	089649-001	Jun 21, 1988		DISCN	No	No
Fresenius Kabi Usa	XYLOCAINE W/ EPINEPHRINE	epinephrine; lidocaine hydrochloride	INJECTABLE;INJECTION	006488-005	Approved Prior to Jan 1, 1982		RX	Yes	Yes
Eastman Kodak	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	epinephrine; lidocaine hydrochloride	INJECTABLE;INJECTION	040057-002	Feb 26, 1993		DISCN	No	No
Hospira	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	epinephrine; lidocaine hydrochloride	INJECTABLE;INJECTION	089635-001	Jun 21, 1988	AP	RX	No	No

Expired US Patents for EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vyteris	LIDOSITE TOPICAL SYSTEM KIT	epinephrine; lidocaine hydrochloride	PATCH;IONTOPHORESIS, TOPICAL	021504-001	May 6, 2004
Vyteris	LIDOSITE TOPICAL SYSTEM KIT	epinephrine; lidocaine hydrochloride	PATCH;IONTOPHORESIS, TOPICAL	021504-001	May 6, 2004
Vyteris	LIDOSITE TOPICAL SYSTEM KIT	epinephrine; lidocaine hydrochloride	PATCH;IONTOPHORESIS, TOPICAL	021504-001	May 6, 2004
Vyteris	LIDOSITE TOPICAL SYSTEM KIT	epinephrine; lidocaine hydrochloride	PATCH;IONTOPHORESIS, TOPICAL	021504-001	May 6, 2004
Vyteris	LIDOSITE TOPICAL SYSTEM KIT	epinephrine; lidocaine hydrochloride	PATCH;IONTOPHORESIS, TOPICAL	021504-001	May 6, 2004
Vyteris	LIDOSITE TOPICAL SYSTEM KIT	epinephrine; lidocaine hydrochloride	PATCH;IONTOPHORESIS, TOPICAL	021504-001	May 6, 2004
Vyteris	LIDOSITE TOPICAL SYSTEM KIT	epinephrine; lidocaine hydrochloride	PATCH;IONTOPHORESIS, TOPICAL	021504-001	May 6, 2004