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Last Updated: August 12, 2020

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EPIPEN Drug Profile

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Which patents cover Epipen, and when can generic versions of Epipen launch?

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

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

The generic ingredient in EPIPEN 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.

US ANDA Litigation and Generic Entry Outlook for Epipen

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

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Drug patent expirations by year for EPIPEN
Drug Prices for EPIPEN

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Recent Clinical Trials for EPIPEN

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

SponsorPhase
Apimeds, Inc.Phase 3
University of North Carolina, Chapel HillPhase 1/Phase 2
National Institute of Allergy and Infectious Diseases (NIAID)Phase 4

See all EPIPEN clinical trials

Paragraph IV (Patent) Challenges for EPIPEN
Tradename Dosage Ingredient NDA Submissiondate
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
EPIPEN JR. INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS epinephrine 019430 2009-07-20

US Patents and Regulatory Information for EPIPEN

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 epinephrine INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 019430-001 Dec 22, 1987 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Mylan Speciality Lp EPIPEN JR. epinephrine INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 019430-002 Dec 22, 1987 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Mylan Speciality Lp EPIPEN epinephrine INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 019430-001 Dec 22, 1987 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Mylan Speciality Lp EPIPEN JR. epinephrine INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 019430-002 Dec 22, 1987 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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