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Last Updated: January 30, 2023

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, 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 fifty-nine 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-nine patent family members in twenty-seven countries.

There are twenty-one drug master file entries for epinephrine. Twenty-five 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
Oman Medical Speciality BoardPhase 4
Beni-Suef UniversityPhase 2
Minia UniversityN/A

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
Hospira LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE epinephrine; lidocaine hydrochloride INJECTABLE;INJECTION 078772-002 May 12, 2008 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Septodont OCTOCAINE epinephrine; lidocaine hydrochloride INJECTABLE;INJECTION 084048-002 Approved Prior to Jan 1, 1982 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
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
Mylan Speciality Lp EPIPEN epinephrine INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 019430-001 Dec 22, 1987 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y 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
Hospira LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE epinephrine; lidocaine hydrochloride INJECTABLE;INJECTION 088571-001 Sep 13, 1985 AP RX 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

International Patents for epinephrine

Country Patent Number Title Estimated Expiration
United Kingdom 2451769 An interactive auto-injector See Plans and Pricing
Denmark 2311510 See Plans and Pricing
New Zealand 555256 Housing, typically similar to credit card size, with compressed gas container, medicament container(s) for user to inject medicament See Plans and Pricing
Poland 2204201 See Plans and Pricing
United Kingdom 2477483 Apparatus and methods for self-administration of vaccines and other medicaments See Plans and Pricing
World Intellectual Property Organization (WIPO) 2018119218 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Moodys
AstraZeneca
McKesson
Mallinckrodt
Merck
Medtronic

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.