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Last Updated: November 24, 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
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Patent Expiration: ⤷  Sign Up

Automatic injector with needle cover
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Patent Expiration: ⤷  Sign Up

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

Automatic injector with needle cover
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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

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