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Last Updated: May 23, 2024

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, Am Regent, Bpi Labs, Intl Medication Sys, Kaleo Inc, Adamis Pharms Corp, Hospira, 3M, Astrazeneca, Dentsply Pharm, Deproco, Septodont Inc, Carlisle, B Braun Medical Inc, Belmora Llc, Eastman Kodak, 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 sixty NDAs. There are thirty-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 patent family members in twenty-four countries.

There are twenty-one drug master file entries for epinephrine. Twenty-one suppliers are listed for this compound. There is one tentative approval 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 Hospital "Sestre Milosrdnice"N/A
University of AlbertaPhase 1
Lawson Health Research InstituteN/A

See all epinephrine clinical trials

Generic filers with tentative approvals for EPINEPHRINE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign UpEQ 1MG BASE/ML (EQ 1MG BASE/ML)SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Bpi Labs EPINEPHRINE epinephrine SOLUTION;INTRAVENOUS 205029-003 May 12, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bpi Labs EPINEPHRINE epinephrine SOLUTION;INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS 205029-001 Jul 29, 2014 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Kaleo Inc AUVI-Q epinephrine SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 201739-003 Nov 17, 2017 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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 ⤷  Sign Up ⤷  Sign Up
Impax ADRENACLICK epinephrine INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 020800-004 Nov 25, 2009 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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