Epinephrine - Generic Drug Details

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

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, Endo Operations, Am Regent, Bpi Labs, Intl Medication Sys, Kaleo Inc, Adamis Pharms Corp, Hospira, Ars Pharms Operation, 3M, Astrazeneca, Dentsply Pharm, Deproco, Septodont Inc, Carlisle, B Braun Medical Inc, Belmora Llc, Eastman Kodak, 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 sixty-two NDAs. There are forty-two 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 seventy patent family members in thirty-one countries.

There are twenty-one drug master file entries for epinephrine. Twenty-two suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for epinephrine

International Patents:	270
US Patents:	42
Tradenames:	34
Applicants:	36
NDAs:	62
Drug Master File Entries:	21
Finished Product Suppliers / Packagers:	22
Raw Ingredient (Bulk) Api Vendors:	88
Clinical Trials:	714
Patent Applications:	6,977
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
Montefiore Medical Center	N/A
University Hospital "Sestre Milosrdnice"	N/A
Jessyka Lighthall	Phase 3

See all epinephrine clinical trials

Generic filers with tentative approvals for EPINEPHRINE

Applicant	Application No.	Strength	Dosage Form
⤷ Subscribe	⤷ Subscribe	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
⤷ Subscribe	⤷ Subscribe	30MG/30ML(1MG/ML)	INJECTABLE;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Astrazeneca	CITANEST FORTE	epinephrine bitartrate; prilocaine hydrochloride	INJECTABLE;INJECTION	014763-008	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Septodont	OCTOCAINE	epinephrine; lidocaine hydrochloride	INJECTABLE;INJECTION	084048-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Mylan Speciality Lp	EPIPEN E Z PEN	epinephrine	INJECTABLE;INTRAMUSCULAR	019430-003	Aug 3, 1995		DISCN	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Endo Operations	ADRENALIN	epinephrine	SOLUTION;INTRAVENOUS	215875-004	Apr 21, 2023		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe	Y			⤷ Subscribe
Impax	ADRENACLICK	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	020800-003	Nov 25, 2009	BX	RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
>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
Kaleo Inc	AUVI-Q	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	201739-002	Aug 10, 2012	⤷ Subscribe	⤷ Subscribe
Kaleo Inc	AUVI-Q	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	201739-002	Aug 10, 2012	⤷ Subscribe	⤷ Subscribe
Kaleo Inc	AUVI-Q	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	201739-002	Aug 10, 2012	⤷ Subscribe	⤷ Subscribe
Kaleo Inc	AUVI-Q	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	201739-003	Nov 17, 2017	⤷ Subscribe	⤷ Subscribe
Kaleo Inc	AUVI-Q	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	201739-001	Aug 10, 2012	⤷ Subscribe	⤷ Subscribe
>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
Hong Kong	1254290	注射器裝置 (SYRINGE DEVICES)	⤷ Subscribe
Slovenia	2311510		⤷ Subscribe
Taiwan	200613027	Automatic injector	⤷ Subscribe
China	103189068	Compositions for drug administration	⤷ Subscribe
Brazil	112018003461	dispositivo de seringa, e método para administrar uma dose terapêutica de pelo menos um medicamento	⤷ Subscribe
>Country	>Patent Number	>Title	>Estimated Expiration

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