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-four 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 one 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:	201
US Patents:	44
Tradenames:	34
Applicants:	35
NDAs:	57
Drug Master File Entries:	21
Suppliers / Packagers:	16
Bulk Api Vendors:	72
Clinical Trials:	510
Patent Applications:	7,014
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
DailyMed Link:	epinephrine at DailyMed

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Drug Sales Revenue Trends for epinephrine

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Recent Clinical Trials for epinephrine

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

Sponsor	Phase
St. Joseph's Healthcare Hamilton	Phase 2
Columbia University	Phase 4
University of Pennsylvania	Phase 4

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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
ADRENALIN	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	epinephrine	204640	2018-08-20
ADRENALIN	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	epinephrine	204200	2016-03-09
EPIPEN JR.	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	epinephrine	019430	2009-07-20
EPI E Z PEN JR	INJECTABLE;INTRAMUSCULAR	epinephrine	019430	2009-07-20
EPIPEN E Z PEN	INJECTABLE;INTRAMUSCULAR	epinephrine	019430	2009-07-20
EPIPEN	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	epinephrine	019430	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
Iomed	IONTOCAINE	epinephrine; lidocaine hydrochloride	SOLUTION;IONTOPHORESIS	020530-001	Dec 21, 1995		DISCN	No	No	Start Trial	Start Trial				Start Trial
Kaleo Inc	AUVI-Q	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	201739-002	Aug 10, 2012	BX	RX	Yes	Yes	Start Trial	Start Trial	Y			Start Trial
Kaleo Inc	AUVI-Q	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	201739-001	Aug 10, 2012	BX	RX	Yes	No	Start Trial	Start Trial	Y			Start Trial
Teva Pharms Usa	EPINEPHRINE (AUTOINJECTOR)	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	090589-002	Aug 16, 2018	AB	RX	No	No	Start Trial	Start Trial				Start Trial
>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	020800-003	Nov 25, 2009	Start Trial	Start Trial
Impax	ADRENACLICK	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	020800-004	Nov 25, 2009	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for epinephrine

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Country	Patent Number	Estimated Expiration
Portugal	2179759	Start Trial
Japan	2008528210	Start Trial
Japan	5277157	Start Trial
Brazil	PI0518460	Start Trial
>Country	>Patent Number	>Estimated Expiration

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