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Last Updated: November 21, 2024

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, Endo Operations, Am Regent, Bpi Labs, Intl Medication Sys, Kaleo Inc, Adamis Pharms Corp, Hospira, Ars Pharms Operation, 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-two NDAs. There are forty-one 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 seventy patent family members in thirty-one 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
Montefiore Medical CenterN/A
University Hospital "Sestre Milosrdnice"N/A
Jessyka LighthallPhase 3

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
Carlisle ALPHACAINE HYDROCHLORIDE W/ EPINEPHRINE epinephrine; lidocaine hydrochloride INJECTABLE;INJECTION 084720-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Watson Labs LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE epinephrine; lidocaine hydrochloride INJECTABLE;INJECTION 085463-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Impax ADRENACLICK epinephrine INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 020800-004 Nov 25, 2009 BX RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  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

International Patents for EPINEPHRINE

Country Patent Number Title Estimated Expiration
Hong Kong 1123758 DEVICES, SYSTEMS AND METHODS FOR MEDICAMENT DELIVERY ⤷  Sign Up
New Zealand 560516 A delivery system where a medicant is automatically delivered on activation as well as a recorded instruction ⤷  Sign Up
Singapore 139748 AUTOMATIC INJECTOR ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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