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Last Updated: July 6, 2020

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Epinephrine - Generic Drug Details

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What are the generic sources for epinephrine and what is the scope of patent protection?

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 one patent family members in twenty-six countries.

There are twenty-one drug master file entries for epinephrine. Sixteen 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
Columbia UniversityPhase 4
University of PennsylvaniaPhase 4

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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
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

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
Iomed IONTOCAINE epinephrine; lidocaine hydrochloride SOLUTION;IONTOPHORESIS 020530-001 Dec 21, 1995 DISCN No No   Start Trial   Start Trial   Start Trial
Kaleo Inc AUVI-Q epinephrine SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 201739-002 Aug 10, 2012 BX RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Kaleo Inc AUVI-Q epinephrine SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 201739-001 Aug 10, 2012 BX RX Yes No   Start Trial   Start Trial Y   Start Trial
Teva Pharms Usa EPINEPHRINE (AUTOINJECTOR) epinephrine INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 090589-002 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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Serving leading biopharmaceutical companies globally:

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Merck
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.