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Last Updated: July 2, 2020

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EPINEPHRINE Drug Profile


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Which patents cover Epinephrine, and what generic alternatives are available?

Epinephrine is a drug marketed by Armstrong Pharms, Intl Medication Sys, Am Regent, Belcher, Teva Pharms Usa, and Hospira Inc. and is included in six NDAs. There are three patents protecting this drug.

The generic ingredient in EPINEPHRINE 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 Epinephrine

A generic version of EPINEPHRINE was approved as epinephrine by BELCHER on July 29th, 2014.

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Paragraph IV (Patent) Challenges for EPINEPHRINE
Tradename Dosage Ingredient NDA Submissiondate
ADRENALIN SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS epinephrine 204640 2018-08-20
ADRENALIN SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS epinephrine 204200 2016-03-09
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
EPIPEN JR. INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS epinephrine 019430 2009-07-20

US Patents and Regulatory Information for EPINEPHRINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Armstrong Pharms EPINEPHRINE epinephrine AEROSOL, METERED;INHALATION 087907-001 May 23, 1984 DISCN No No   Start Trial   Start Trial   Start Trial
Belcher EPINEPHRINE epinephrine SOLUTION;INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS 205029-001 Jul 29, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Belcher EPINEPHRINE epinephrine SOLUTION;INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS 205029-001 Jul 29, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Intl Medication Sys EPINEPHRINE epinephrine SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS 211880-001 Apr 24, 2020 AP RX 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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Serving leading biopharmaceutical companies globally:

Colorcon
Boehringer Ingelheim
McKesson
Merck
Mallinckrodt
Baxter

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