ADRENALIN Drug Patent Profile

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

Adrenalin is a drug marketed by Endo Operations and is included in three NDAs. There are six patents protecting this drug and two Paragraph IV challenges.

This drug has nine patent family members in seven countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Adrenalin

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

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Summary for ADRENALIN

International Patents:	9
US Patents:	6
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	45
Patent Applications:	2,237
Drug Prices:	Drug price information for ADRENALIN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ADRENALIN
What excipients (inactive ingredients) are in ADRENALIN?	ADRENALIN excipients list
DailyMed Link:	ADRENALIN at DailyMed

Drug patent expirations by year for ADRENALIN

Recent Clinical Trials for ADRENALIN

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

Sponsor	Phase
The Second Affiliated Hospital of Harbin Medical University	Early Phase 1
The First Affiliated Hospital of Nanchang University	Early Phase 1
China-Japan Friendship Hospital	Early Phase 1

See all ADRENALIN clinical trials

Pharmacology for ADRENALIN

Drug Class	Catecholamine alpha-Adrenergic Agonist beta-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists Adrenergic beta-Agonists

Paragraph IV (Patent) Challenges for ADRENALIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ADRENALIN	Injection	epinephrine	30 mg/30 mL	204640	1	2018-08-20
ADRENALIN	Injection	epinephrine	1 mg/mL ampules	204200	1	2016-03-09

US Patents and Regulatory Information for ADRENALIN

ADRENALIN is protected by six US patents.

Patents protecting ADRENALIN

Epinephrine formulations
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Patent Expiration: ⤷ Sign Up

Epinephrine compositions and containers
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Epinephrine compositions and containers
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Patent Expiration: ⤷ Sign Up
Patented Use: TO INCREASE MEAN ARTERIAL BLOOD PRESSURE IN ADULT PATIENTS WITH HYPOTENSION ASSOCIATED WITH SEPTIC SHOCK

Epinephrine compositions and containers
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Epinephrine formulations
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Epinephrine formulations
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Patented Use: EMERGENCY TREATMENT OF ALLERGIC REACTIONS (TYPE I), INCLUDING ANAPHYLAXIS

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Endo Operations	ADRENALIN	epinephrine	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	204200-001	Dec 7, 2012		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Endo Operations	ADRENALIN	epinephrine	SOLUTION;INTRAVENOUS	215875-005	Apr 21, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Endo Operations	ADRENALIN	epinephrine	SOLUTION;INTRAVENOUS	215875-001	Apr 21, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Endo Operations	ADRENALIN	epinephrine	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	204640-001	Dec 18, 2013	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for ADRENALIN

See the table below for patents covering ADRENALIN around the world.

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Country	Patent Number	Title	Estimated Expiration
Japan	2018507915	エピネフリン製剤	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2016149028		⤷ Sign Up
Canada	2978464	FORMULATIONS D'EPINEPHRINE (EPINEPHRINE FORMULATIONS)	⤷ Sign Up
China	107614017	肾上腺素制剂 (EPINEPHRINE FORMULATIONS)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration