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Last Updated: May 6, 2021

DrugPatentWatch Database Preview

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-six 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 ten 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
Saskatoon City HospitalN/A
Assiut UniversityPhase 4
University of SaskatchewanN/A

See all epinephrine clinical trials

Paragraph IV (Patent) Challenges for EPINEPHRINE
Tradename Dosage Ingredient NDA Submissiondate
EPINEPHRINE SOLUTION;INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS epinephrine 205029 2020-08-13
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
Hospira LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE epinephrine; lidocaine hydrochloride INJECTABLE;INJECTION 088571-001 Sep 13, 1985 AP RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Kaleo Inc AUVI-Q epinephrine SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 201739-001 Aug 10, 2012 BX RX Yes No   Get Started for $10   Get Started for $10 Y   Get Started for $10
Dentsply Pharm CITANEST FORTE DENTAL epinephrine bitartrate; prilocaine hydrochloride INJECTABLE;INJECTION 021383-001 Approved Prior to Jan 1, 1982 AP RX Yes Yes   Get Started for $10   Get Started for $10   Get Started for $10
Intl Medication Sys EPINEPHRINE epinephrine SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS 211880-001 Apr 24, 2020 AP RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Kaleo Inc AUVI-Q epinephrine SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 201739-003 Nov 17, 2017 RX Yes No   Get Started for $10   Get Started for $10 Y   Get Started for $10
Bel Mar LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE epinephrine; lidocaine hydrochloride INJECTABLE;INJECTION 080820-001 Approved Prior to Jan 1, 1982 DISCN No No   Get Started for $10   Get Started for $10   Get Started for $10
Fresenius Kabi Usa XYLOCAINE W/ EPINEPHRINE epinephrine; lidocaine hydrochloride INJECTABLE;INJECTION 006488-018 Nov 13, 1986 RX Yes Yes   Get Started for $10   Get Started for $10   Get Started for $10
>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 020800-004 Nov 25, 2009   Get Started for $10   Get Started for $10
Impax ADRENACLICK epinephrine INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 020800-003 Nov 25, 2009   Get Started for $10   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for epinephrine

Country Patent Number Estimated Expiration
European Patent Office 2179759   Get Started for $10
China 101166551   Get Started for $10
United Kingdom 201105021   Get Started for $10
Taiwan 200613027   Get Started for $10
European Patent Office 1843812   Get Started for $10
Spain 2577517   Get Started for $10
Norway 20073488   Get Started for $10
>Country >Patent Number >Estimated Expiration

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