Epinephrine - Generic Drug Details

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

Epinephrine is the generic ingredient in thirty-three branded drugs marketed by Sterling, Armstrong Pharms, Wyeth Cons, Forest Labs, Mylan Speciality Lp, Impax, Teva Pharms Usa, Par Sterile Products, Belcher, Intl Medication Sys, Kaleo Inc, Am Regent, Adamis Pharms Corp, Hospira Inc, 3M, Astrazeneca, Dentsply Pharm, Deproco, Septodont Inc, 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, Fresenius Kabi Usa, Vyteris, Iomed, and Empi, and is included in fifty-eight NDAs. There are forty-six patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Epinephrine has two hundred and eleven patent family members in twenty-six countries.

There are twenty-one drug master file entries for epinephrine. Seventeen suppliers are listed for this compound.

Summary for epinephrine

International Patents:	211
US Patents:	46
Tradenames:	33
Applicants:	36
NDAs:	58
Drug Master File Entries:	21
Finished Product Suppliers / Packagers:	17
Raw Ingredient (Bulk) Api Vendors:	77
Clinical Trials:	641
Patent Applications:	7,039
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for epinephrine
Drug Sales Revenues:	Drug sales revenues for epinephrine
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for epinephrine
What excipients (inactive ingredients) are in epinephrine?	epinephrine excipients list
DailyMed Link:	epinephrine at DailyMed

See drug prices for epinephrine

Drug Sales Revenue Trends for epinephrine

See drug sales revenues for epinephrine

Recent Clinical Trials for epinephrine

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

Sponsor	Phase
University of Southern California	Phase 4
ARS Pharmaceuticals, Inc.	Phase 2
Qazvin University Of Medical Sciences	Phase 2

See all epinephrine clinical trials

Pharmacology for epinephrine

Drug Class	Catecholamine alpha-Adrenergic Agonist beta-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists Adrenergic beta-Agonists

Medical Subject Heading (MeSH) Categories for epinephrine

Adrenergic alpha-Agonists
Adrenergic beta-Agonists
Bronchodilator Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents

Anatomical Therapeutic Chemical (ATC) Classes for epinephrine

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

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

Paragraph IV (Patent) Challenges for EPINEPHRINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EPINEPHRINE	Injection	epinephrine	1 mg/mL	205029	1	2020-08-13
ADRENALIN	Injection	epinephrine	30 mg/30 mL	204640	1	2018-08-20
ADRENALIN	Injection	epinephrine	1 mg/mL ampules	204200	1	2016-03-09
EPIPEN JR.	Injection (Auto- injector)	epinephrine	0.15 mg/0.3 mL and 0.3 mg/0.3 mL	019430	1	2009-07-20

US Patents and Regulatory Information for epinephrine

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Pharms Usa	EPINEPHRINE (AUTOINJECTOR)	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	090589-002	Aug 16, 2018	AB	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Forest Labs	SUS-PHRINE SULFITE FREE	epinephrine	INJECTABLE;INJECTION	007942-003	Feb 5, 1999		DISCN	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Kaleo Inc	AUVI-Q	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	201739-002	Aug 10, 2012	BX	RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for epinephrine

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Impax	ADRENACLICK	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	020800-004	Nov 25, 2009	See Plans and Pricing	See Plans and Pricing
Impax	ADRENACLICK	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	020800-003	Nov 25, 2009	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for epinephrine

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Country	Patent Number	Title	Estimated Expiration
South Korea	20070083539	AUTOMATIC INJECTOR	See Plans and Pricing
Brazil	PI0518415	aparelho formando um dispositivo de injeÇço de medicamento, e, mÉtodos para acionar uma agulha de seringa atÉ uma profundidade de penetraÇço selecionada, e para injetar medicamento de uma seringa e armazenar a seringa apàs injeÇço do medicamento	See Plans and Pricing
Japan	2010510000		See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration

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