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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-four branded drugs marketed by Sterling, Armstrong Pharms, Wyeth Cons, Forest Labs, Mylan Speciality Lp, Impax, Teva Pharms Usa, Par Sterile Products, Intl Medication Sys, Kaleo Inc, Am Regent, Adamis Pharms Corp, Hospira Inc, Belcher, 3M, Astrazeneca, Dentsply Pharm, Deproco, Septodont Inc, Carlisle, 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-seven 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 ten patent family members in twenty-six countries.

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

Summary for epinephrine

International Patents:	210
US Patents:	46
Tradenames:	34
Applicants:	35
NDAs:	57
Drug Master File Entries:	21
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	77
Clinical Trials:	554
Patent Applications:	7,024
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

See drug sales revenues for epinephrine

Recent Clinical Trials for epinephrine

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

Sponsor	Phase
Saskatoon City Hospital	N/A
Assiut University	Phase 4
University of Saskatchewan	N/A

See all epinephrine clinical trials

Pharmacology for epinephrine

Drug Class	alpha-Adrenergic Agonist beta-Adrenergic Agonist Catecholamine
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

Paragraph IV (Patent) Challenges for EPINEPHRINE

Tradename	Dosage	Ingredient	NDA	Submissiondate
EPINEPHRINE	SOLUTION;INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS	epinephrine	205029	2020-08-13
ADRENALIN	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	epinephrine	204640	2018-08-20
ADRENALIN	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	epinephrine	204200	2016-03-09
EPIPEN E Z PEN	INJECTABLE;INTRAMUSCULAR	epinephrine	019430	2009-07-20
EPIPEN	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	epinephrine	019430	2009-07-20
EPIPEN JR.	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	epinephrine	019430	2009-07-20
EPI E Z PEN JR	INJECTABLE;INTRAMUSCULAR	epinephrine	019430	2009-07-20

US Patents and Regulatory Information for epinephrine

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
Kaleo Inc	AUVI-Q	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	201739-001	Aug 10, 2012	BX	RX	Yes	No			Y
Dentsply Pharm	CITANEST FORTE DENTAL	epinephrine bitartrate; prilocaine hydrochloride	INJECTABLE;INJECTION	021383-001	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes
Intl Medication Sys	EPINEPHRINE	epinephrine	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	211880-001	Apr 24, 2020	AP	RX	No	No
Kaleo Inc	AUVI-Q	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	201739-003	Nov 17, 2017		RX	Yes	No			Y
Bel Mar	LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE	epinephrine; lidocaine hydrochloride	INJECTABLE;INJECTION	080820-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Fresenius Kabi Usa	XYLOCAINE W/ EPINEPHRINE	epinephrine; lidocaine hydrochloride	INJECTABLE;INJECTION	006488-018	Nov 13, 1986		RX	Yes	Yes

Expired US Patents for epinephrine

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

International Patents for epinephrine

Country	Patent Number	Estimated Expiration
European Patent Office	2179759
China	101166551
United Kingdom	201105021
Taiwan	200613027
European Patent Office	1843812
Spain	2577517
Norway	20073488