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EPIPEN JR. Drug Profile

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When do Epipen Jr. patents expire, and when can generic versions of Epipen Jr. launch?

Epipen Jr. is a drug marketed by Mylan Speciality Lp and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has forty-seven patent family members in eighteen countries.

The generic ingredient in EPIPEN JR. is epinephrine. There are twenty-one drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the epinephrine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Epipen Jr.

A generic version of EPIPEN JR. was approved as epinephrine by BELCHER on July 29^th, 2014.

Summary for EPIPEN JR.

International Patents:	47
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	76
Clinical Trials:	10
Patent Applications:	4,415
Formulation / Manufacturing:	see details
DailyMed Link:	EPIPEN JR. at DailyMed

Recent Clinical Trials for EPIPEN JR.

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

Sponsor	Phase
Jeffrey Alan Klein, MD	Phase 2/Phase 3
Nasus Pharma	Phase 1
Apimeds, Inc.	Phase 3

See all EPIPEN JR. clinical trials

Pharmacology for EPIPEN JR.

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

ATC Classes for EPIPEN JR.

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 EPIPEN JR.

Tradename	Dosage	Ingredient	NDA	Submissiondate
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 EPIPEN JR.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Speciality Lp	EPIPEN JR.	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	019430-002	Dec 22, 1987	AB	RX	Yes	Yes			Y
Mylan Speciality Lp	EPIPEN JR.	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	019430-002	Dec 22, 1987	AB	RX	Yes	Yes			Y
Mylan Speciality Lp	EPIPEN JR.	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	019430-002	Dec 22, 1987	AB	RX	Yes	Yes			Y
Mylan Speciality Lp	EPIPEN JR.	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	019430-002	Dec 22, 1987	AB	RX	Yes	Yes			Y

International Patents for EPIPEN JR.

Country	Patent Number	Estimated Expiration
Portugal	2179759
Denmark	2204201
Japan	4806712
European Patent Office	1786491