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Last Updated: June 14, 2021

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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 one Paragraph IV challenge.

This drug has forty-seven 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.

DrugPatentWatch® 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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Paragraph IV (Patent) Challenges for EPIPEN
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

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   Get Started Free   Get Started Free Y   Get Started Free
Mylan Speciality Lp EPIPEN JR. epinephrine INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 019430-002 Dec 22, 1987 AB RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Mylan Speciality Lp EPIPEN epinephrine INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 019430-001 Dec 22, 1987 AB RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Mylan Speciality Lp EPIPEN JR. epinephrine INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 019430-002 Dec 22, 1987 AB RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Mylan Speciality Lp EPIPEN epinephrine INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 019430-001 Dec 22, 1987 AB RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Mylan Speciality Lp EPIPEN epinephrine INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 019430-001 Dec 22, 1987 AB RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Mylan Speciality Lp EPIPEN E Z PEN epinephrine INJECTABLE;INTRAMUSCULAR 019430-003 Aug 3, 1995 DISCN No No   Get Started Free   Get Started Free   Get Started Free
>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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Serving leading biopharmaceutical companies globally:

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Johnson and Johnson

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