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Last Updated: September 22, 2023

EVZIO (AUTOINJECTOR) Drug Patent Profile

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When do Evzio (autoinjector) patents expire, and what generic alternatives are available?

Evzio (autoinjector) is a drug marketed by Kaleo Inc and is included in one NDA. There are thirty-three patents protecting this drug.

This drug has one hundred and forty-three patent family members in fifteen countries.

The generic ingredient in EVZIO (AUTOINJECTOR) is naloxone hydrochloride. There are twelve drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Evzio (autoinjector)

A generic version of EVZIO (AUTOINJECTOR) was approved as naloxone hydrochloride by HOSPIRA on September 24^th, 1986.

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Summary for EVZIO (AUTOINJECTOR)

International Patents:	143
US Patents:	33
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	61
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EVZIO (AUTOINJECTOR)
DailyMed Link:	EVZIO (AUTOINJECTOR) at DailyMed

Drug patent expirations by year for EVZIO (AUTOINJECTOR)

Recent Clinical Trials for EVZIO (AUTOINJECTOR)

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

Sponsor	Phase
Ionis Pharmaceuticals, Inc.	Phase 1
CSL Behring	Phase 1
Parexel	Phase 1

See all EVZIO (AUTOINJECTOR) clinical trials

Pharmacology for EVZIO (AUTOINJECTOR)

Drug Class	Opioid Antagonist
Mechanism of Action	Opioid Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for EVZIO (AUTOINJECTOR)

A06AH	Peripheral opioid receptor antagonists
A06A	DRUGS FOR CONSTIPATION
A06	DRUGS FOR CONSTIPATION
A	Alimentary tract and metabolism

V03AB	Antidotes
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

US Patents and Regulatory Information for EVZIO (AUTOINJECTOR)

EVZIO (AUTOINJECTOR) is protected by thirty-three US patents.

Patents protecting EVZIO (AUTOINJECTOR)

Medicament delivery device for administration of opioid antagonists including formulations for naloxone
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE OF A DELIVERY DEVICE TO DELIVER A DOSE OF NALOXONE

Devices and methods for delivering opioid antagonists including formulations for naloxone
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE OF A DELIVERY DEVICE TO DELIVER A BIOEQUIVALENT DOSE OF A NALOXONE COMPOSITION VIA A NEEDLE

Devices, systems and methods for medicament delivery
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Medicament delivery device for administration of opioid antagonists including formulations for naloxone
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE OF A DELIVERY DEVICE TO ADMINISTER A DOSE OF NALOXONE

Devices, systems and methods for medicament delivery
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Devices, systems and methods for medicament delivery
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Devices, systems and methods for medicament delivery
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Devices, systems and methods for medicament delivery
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Devices, systems and methods for medicament delivery
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Devices, systems, and methods for medicament delivery
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Devices, systems and methods for medicament delivery
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Devices, systems and methods for medicament delivery
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Devices, systems and methods for medicament delivery
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Medicament delivery device configured to produce an audible output
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Patent Expiration: ⤷ Try a Trial

Devices, systems and methods for medicament delivery
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Medical injector with compliance tracking and monitoring
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Medicament delivery device having an electronic circuit system
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Devices, systems and methods for medicament delivery
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Devices, systems and methods for medicament delivery
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Devices, systems, and methods for medicament delivery
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Devices, systems and methods for medicament delivery
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Medicament delivery device for administration of opioid antagonists including formulations for naloxone
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Devices, systems and methods for medicament delivery
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Medicament delivery device for administration of opioid antagonists including formulations for naloxone
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Medicament delivery device for administration of opioid antagonists including formulations for naloxone
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Devices, systems and methods for medicament delivery
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Medicament delivery device having an electronic circuit system
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Devices, systems and methods for medicament delivery
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Medicament delivery device for administration of opioid antagonists including formulations for naloxone
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE OF A DELIVERY DEVICE TO ADMINISTER A DOSE OF NALOXONE

Devices and methods for delivering opioid antagonists including formulations for naloxone
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE OF AN AUTO INJECTOR TO ADMINISTER NALOXONE HCL

Devices, systems, and methods for medicament delivery
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD FOR CONFIRMING DOSE DELIVERY

Devices, systems and methods for medicament delivery
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

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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
Kaleo Inc	EVZIO (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	209862-001	Oct 19, 2016		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Kaleo Inc	EVZIO (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	209862-001	Oct 19, 2016		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Kaleo Inc	EVZIO (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	209862-001	Oct 19, 2016		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Kaleo Inc	EVZIO (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	209862-001	Oct 19, 2016		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Kaleo Inc	EVZIO (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	209862-001	Oct 19, 2016		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Kaleo Inc	EVZIO (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	209862-001	Oct 19, 2016		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Kaleo Inc	EVZIO (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	209862-001	Oct 19, 2016		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ 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

International Patents for EVZIO (AUTOINJECTOR)

See the table below for patents covering EVZIO (AUTOINJECTOR) around the world.

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Country	Patent Number	Title	Estimated Expiration
Australia	2004325202	Devices, systems, and methods for medicament delivery	⤷ Try a Trial
United Kingdom	201313757		⤷ Try a Trial
Australia	2015255197	MEDICAMENT DELIVERY DEVICES FOR ADMINISTRATION OF A MEDICAMENT WITHIN A PREFILLED SYRINGE	⤷ Try a Trial
United Kingdom	2451769	An interactive auto-injector	⤷ Try a Trial
United Kingdom	2502485	Medicament delivery device for administration of opioid antagonists including formulations for naloxone	⤷ Try a Trial
United Kingdom	0708523		⤷ Try a Trial
United Kingdom	201114400		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for EVZIO (AUTOINJECTOR)

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1685839	92292	Luxembourg	⤷ Try a Trial	PRODUCT NAME: COMBINAISON D OXYCODONE EN TANT QUE COMPOSANT A ET DE NALOXONE EN TANT QUE COMPOSANT B SOUS TOUTES LES FORMES PROTEGES PAR LE BREVET DE BASE
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim

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Johnson and Johnson

AstraZeneca

Moodys

Baxter

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