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Last Updated: August 17, 2022

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-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-seven 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 thirty-four patent family members in twenty-six countries.

There are twenty-one drug master file entries for epinephrine. Seventeen 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 of SaskatchewanPhase 1/Phase 2
University of Southern CaliforniaPhase 4
Assaf-Harofeh Medical CenterPhase 4

See all EPINEPHRINE clinical trials

Generic filers with tentative approvals for EPINEPHRINE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and PricingEQ 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
Kaleo Inc AUVI-Q epinephrine SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 201739-001 Aug 10, 2012 BX RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Eastman Kodak LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE epinephrine; lidocaine hydrochloride INJECTABLE;INJECTION 040057-001 Feb 26, 1993 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Impax ADRENACLICK epinephrine INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 020800-003 Nov 25, 2009 BX RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Wyeth Cons BRONITIN MIST epinephrine bitartrate AEROSOL, METERED;INHALATION 016126-002 Approved Prior to Jan 1, 1982 DISCN No No See Plans and Pricing See Plans and Pricing 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 020800-003 Nov 25, 2009 See Plans and Pricing See Plans and Pricing
Impax ADRENACLICK epinephrine INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 020800-004 Nov 25, 2009 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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.