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Last Updated: November 18, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019430

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NDA 019430 describes EPIPEN JR., which is a drug marketed by Mylan Speciality Lp and is included in one NDA. It is available from four suppliers. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the EPIPEN JR. profile page.

The generic ingredient in EPIPEN JR. is epinephrine. There are twenty-one drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the epinephrine profile page.
Summary for 019430
Tradename:EPIPEN JR.
Applicant:Mylan Speciality Lp
Ingredient:epinephrine
Patents:5
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 019430
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EPI E Z PEN JR epinephrine INJECTABLE;INTRAMUSCULAR 019430 NDA AUTHORIZED GENERIC Mylan Specialty L.P. 49502-101 49502-101-02 2 CONTAINER in 1 CARTON (49502-101-02) > 1 SYRINGE, GLASS in 1 CONTAINER (49502-101-01) > .3 mL in 1 SYRINGE, GLASS
EPIPEN E Z PEN epinephrine INJECTABLE;INTRAMUSCULAR 019430 NDA AUTHORIZED GENERIC Mylan Specialty L.P. 49502-101 49502-101-02 2 CONTAINER in 1 CARTON (49502-101-02) > 1 SYRINGE, GLASS in 1 CONTAINER (49502-101-01) > .3 mL in 1 SYRINGE, GLASS
Paragraph IV (Patent) Challenges for 019430
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

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUSStrength0.3MG/DELIVERY
Approval Date:Dec 22, 1987TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Sep 11, 2025Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Sep 11, 2025Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Sep 11, 2025Product Flag?YSubstance Flag?Delist Request?

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