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Last Updated: August 15, 2020

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EPIPEN E Z PEN Drug Profile

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

Epipen E Z Pen is a drug marketed by Mylan Speciality Lp and is included in one NDA.

The generic ingredient in EPIPEN E Z PEN 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 E Z Pen

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

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Drug patent expirations by year for EPIPEN E Z PEN
Recent Clinical Trials for EPIPEN E Z PEN

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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 E Z PEN clinical trials

Paragraph IV (Patent) Challenges for EPIPEN E Z PEN
Tradename Dosage Ingredient NDA Submissiondate
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 EPIPEN E Z PEN

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 E Z PEN epinephrine INJECTABLE;INTRAMUSCULAR 019430-003 Aug 3, 1995 DISCN 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

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