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Last Updated: September 28, 2020

DrugPatentWatch Database Preview

Epinephrine - Generic Drug Details

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What are the generic drug sources for epinephrine and what is the scope of freedom to operate?

Epinephrine is the generic ingredient in thirty-four branded drugs marketed by Sterling, Armstrong Pharms, Wyeth Cons, Forest Labs, Mylan Speciality Lp, Impax, Teva Pharms Usa, Par Sterile Products, Intl Medication Sys, Kaleo Inc, Am Regent, Adamis Pharms Corp, Hospira Inc, Belcher, 3M, Astrazeneca, Dentsply Pharm, Deproco, Septodont Inc, Carlisle, Belmora Llc, Eastman Kodak, Hospira, West-ward Pharms Int, Abbott, Bel Mar, Dell Labs, Intl Medication, Watson Labs, Pharmaton, Septodont, Fresenius Kabi Usa, Vyteris, Iomed, and Empi, and is included in fifty-seven NDAs. There are forty-four patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Epinephrine has two hundred and three patent family members in twenty-six countries.

There are twenty-one drug master file entries for epinephrine. Fifteen suppliers are listed for this compound.

Drug Prices for epinephrine

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Drug Sales Revenue Trends for epinephrine

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Recent Clinical Trials for epinephrine

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

SponsorPhase
St. Joseph's Healthcare HamiltonPhase 2
Antonios LikourezosPhase 4
CMC Ambroise ParéN/A

See all epinephrine clinical trials

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
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
EPI E Z PEN JR INJECTABLE;INTRAMUSCULAR 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
Kaleo Inc AUVI-Q epinephrine SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 201739-001 Aug 10, 2012 BX RX Yes No   Start Trial   Start Trial   Start Trial
Kaleo Inc AUVI-Q epinephrine SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 201739-003 Nov 17, 2017 RX Yes No   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
Hospira LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE epinephrine; lidocaine hydrochloride INJECTABLE;INJECTION 089635-001 Jun 21, 1988 AP RX No No   Start Trial   Start Trial   Start Trial
Astrazeneca DURANEST epinephrine bitartrate; etidocaine hydrochloride INJECTABLE;INJECTION 017751-006 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   Start Trial
Teva Pharms Usa EPINEPHRINE (AUTOINJECTOR) epinephrine INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 090589-001 Aug 16, 2018 AB 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

Expired US Patents for epinephrine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Impax ADRENACLICK epinephrine INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 020800-003 Nov 25, 2009   Start Trial   Start Trial
Impax ADRENACLICK epinephrine INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 020800-004 Nov 25, 2009   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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