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Last Updated: November 2, 2024

EPIPEN JR. Drug Patent 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. Twenty-one 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 BPI LABS on July 29th, 2014.

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Summary for EPIPEN JR.
Drug patent expirations by year for EPIPEN JR.
Recent Clinical Trials for EPIPEN JR.

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

SponsorPhase
Jeffrey Alan Klein, MDPhase 2/Phase 3
Nasus PharmaPhase 1
Apimeds, Inc.Phase 3

See all EPIPEN JR. clinical trials

Paragraph IV (Patent) Challenges for EPIPEN JR.
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
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 EPIPEN JR.

EPIPEN JR. is protected by five US patents.

Patents protecting EPIPEN JR.

Automatic injector
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Automatic injector with kickback attenuation
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Automatic injector with needle cover
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Automatic injector
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Automatic injector with needle cover
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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

International Patents for EPIPEN JR.

See the table below for patents covering EPIPEN JR. around the world.

Country Patent Number Title Estimated Expiration
Cyprus 1122922 ⤷  Sign Up
Denmark 2179759 ⤷  Sign Up
Spain 2792185 ⤷  Sign Up
Israel 181118 AUTOMATIC INJECTOR ⤷  Sign Up
Japan 4362143 ⤷  Sign Up
Portugal 2204201 ⤷  Sign Up
Canada 2683253 INJECTEUR AUTOMATIQUE AVEC COUVRE-AIGUILLE (AUTOMATIC INJECTOR WITH NEEDLE COVER) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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