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Last Updated: March 19, 2024

EPINEPHRINE Drug Patent Profile


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Which patents cover Epinephrine, and what generic alternatives are available?

Epinephrine is a drug marketed by Armstrong Pharms, Am Regent, Bpi Labs, Intl Medication Sys, Hospira, and Teva Pharms Usa. and is included in seven NDAs. There are three patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in EPINEPHRINE is epinephrine. There are twenty-one drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the epinephrine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Epinephrine

A generic version of EPINEPHRINE was approved as epinephrine by BPI LABS on July 29th, 2014.

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Drug patent expirations by year for EPINEPHRINE
Drug Prices for EPINEPHRINE

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Drug Sales Revenue Trends for EPINEPHRINE

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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

EPINEPHRINE is protected by five US patents.

Patents protecting EPINEPHRINE

More potent and less toxic formulations of epinephrine and methods of medical use
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: EMERGENCY TREATMENT OF ALLERGIC REACTIONS (TYPE 1), INCLUDING ANAPHYLAXIS; A METHOD OF TREATING ALLERGIC REACTION, ANAPHYLAXIS, ANAPHYLACTIC SHOCK, OR COMBINATION THEREOF BY AN INJECTION OF AT LEAST ONE DOSAGE OF THE INJECTABLE LIQUID PHARMACEUTICAL

More potent and less toxic formulations of epinephrine and methods of medical use
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: INCREASING MEAN ARTERIAL BLOOD PRESSURE IN ADULT PATIENTS WITH HYPOTENSION ASSOCIATED WITH SEPTIC SHOCK

More potent and less toxic formulations of epinephrine and methods of medical use
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: EMERGENCY TREATMENT OF ALLERGIC REACTIONS (TYPE I), INCLUDING ANAPHYLAXIS

More potent and less toxic formulations of epinephrine and methods of medical use
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: INCREASING MEAN ARTERIAL BLOOD PRESSURE IN ADULT PATIENTS WITH HYPOTENSION ASSOCIATED WITH SEPTIC SHOCK

More potent and less toxic formulations of epinephrine and methods of medical use
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: INDUCTION AND MAINTENANCE OF MYDRIASIS DURING INTRAOCULAR SURGERY

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Armstrong Pharms EPINEPHRINE epinephrine AEROSOL, METERED;INHALATION 087907-001 May 23, 1984 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Intl Medication Sys EPINEPHRINE epinephrine SOLUTION;INTRAVENOUS 211363-001 Aug 15, 2022 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Intl Medication Sys EPINEPHRINE epinephrine SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS 211880-001 Apr 24, 2020 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bpi Labs EPINEPHRINE epinephrine SOLUTION;INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS 205029-001 Jul 29, 2014 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Teva Pharms Usa EPINEPHRINE (AUTOINJECTOR) epinephrine INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 090589-001 Aug 16, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Am Regent EPINEPHRINE epinephrine SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS 207568-001 Jul 6, 2018 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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