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Last Updated: May 25, 2022

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-three branded drugs marketed by Sterling, Armstrong Pharms, Wyeth Cons, Forest Labs, Mylan Speciality Lp, Impax, Teva Pharms Usa, Par Sterile Products, Belcher, Intl Medication Sys, Kaleo Inc, Am Regent, Adamis Pharms Corp, Hospira Inc, 3M, Astrazeneca, Dentsply Pharm, Deproco, Septodont Inc, Carlisle, B Braun Medical Inc, 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-eight 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 eleven patent family members in twenty-six countries.

There are twenty-one drug master file entries for epinephrine. Seventeen 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
University of Southern CaliforniaPhase 4
ARS Pharmaceuticals, Inc.Phase 2
Qazvin University Of Medical SciencesPhase 2

See all epinephrine clinical trials

Paragraph IV (Patent) Challenges for EPINEPHRINE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
EPINEPHRINE Injection epinephrine 1 mg/mL 205029 1 2020-08-13
ADRENALIN Injection epinephrine 30 mg/30 mL 204640 1 2018-08-20
ADRENALIN Injection epinephrine 1 mg/mL ampules 204200 1 2016-03-09
EPIPEN JR. Injection (Auto- injector) epinephrine 0.15 mg/0.3 mL and 0.3 mg/0.3 mL 019430 1 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
Teva Pharms Usa EPINEPHRINE (AUTOINJECTOR) epinephrine INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 090589-002 Aug 16, 2018 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Forest Labs SUS-PHRINE SULFITE FREE epinephrine INJECTABLE;INJECTION 007942-003 Feb 5, 1999 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Kaleo Inc AUVI-Q epinephrine SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 201739-002 Aug 10, 2012 BX RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Impax ADRENACLICK epinephrine INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 020800-003 Nov 25, 2009 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for epinephrine

Country Patent Number Title Estimated Expiration
South Korea 20070083539 AUTOMATIC INJECTOR See Plans and Pricing
Brazil PI0518415 aparelho formando um dispositivo de injeÇço de medicamento, e, mÉtodos para acionar uma agulha de seringa atÉ uma profundidade de penetraÇço selecionada, e para injetar medicamento de uma seringa e armazenar a seringa apàs injeÇço do medicamento See Plans and Pricing
Japan 2010510000 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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