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Last Updated: August 4, 2020

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ADRENALIN Drug Profile

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When do Adrenalin patents expire, and what generic alternatives are available?

Adrenalin is a drug marketed by Par Sterile Products and is included in two NDAs. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has seven patent family members in seven countries.

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

US ANDA Litigation and Generic Entry Outlook for Adrenalin

A generic version of ADRENALIN was approved as epinephrine by BELCHER on July 29th, 2014.

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Drug patent expirations by year for ADRENALIN
Drug Prices for ADRENALIN

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Drug Sales Revenue Trends for ADRENALIN

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Recent Clinical Trials for ADRENALIN

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Stanford UniversityEarly Phase 1
Assiut UniversityPhase 2
Cairo UniversityPhase 1/Phase 2

See all ADRENALIN clinical trials

Paragraph IV (Patent) Challenges for ADRENALIN
Tradename Dosage Ingredient NDA Submissiondate
ADRENALIN SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS epinephrine 204640 2018-08-20
ADRENALIN SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS epinephrine 204200 2016-03-09

US Patents and Regulatory Information for ADRENALIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Par Sterile Products ADRENALIN epinephrine SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS 204200-001 Dec 7, 2012 RX Yes Yes   Start Trial   Start Trial   Start Trial
Par Sterile Products ADRENALIN epinephrine SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS 204640-001 Dec 18, 2013 AP RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Par Sterile Products ADRENALIN epinephrine SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS 204200-001 Dec 7, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Par Sterile Products ADRENALIN epinephrine SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS 204640-001 Dec 18, 2013 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
Par Sterile Products ADRENALIN epinephrine SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS 204640-001 Dec 18, 2013 AP RX Yes Yes   Start Trial   Start Trial Y   Start 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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Serving leading biopharmaceutical companies globally:

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