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Last Updated: November 21, 2024

NALOXONE HYDROCHLORIDE (AUTOINJECTOR) Drug Patent Profile


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Which patents cover Naloxone Hydrochloride (autoinjector), and when can generic versions of Naloxone Hydrochloride (autoinjector) launch?

Naloxone Hydrochloride (autoinjector) is a drug marketed by Kaleo Inc and is included in one NDA. There are eighteen patents protecting this drug.

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

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Naloxone Hydrochloride (autoinjector)

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

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Drug patent expirations by year for NALOXONE HYDROCHLORIDE (AUTOINJECTOR)
Recent Clinical Trials for NALOXONE HYDROCHLORIDE (AUTOINJECTOR)

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

SponsorPhase
PfizerPhase 1
National Institute on Drug Abuse (NIDA)Phase 1

See all NALOXONE HYDROCHLORIDE (AUTOINJECTOR) clinical trials

Pharmacology for NALOXONE HYDROCHLORIDE (AUTOINJECTOR)
Drug ClassOpioid Antagonist
Mechanism of ActionOpioid Antagonists

US Patents and Regulatory Information for NALOXONE HYDROCHLORIDE (AUTOINJECTOR)

NALOXONE HYDROCHLORIDE (AUTOINJECTOR) is protected by eighteen US patents.

Patents protecting NALOXONE HYDROCHLORIDE (AUTOINJECTOR)

Medicament delivery device for administration of opioid antagonists including formulations for naloxone
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Patented Use: USE OF A DELIVERY DEVICE TO DELIVER A DOSE OF NALOXONE

Devices, systems and methods for medicament delivery
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Medicament delivery device for administration of opioid antagonists including formulations for naloxone
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: USE OF A DELIVERY DEVICE TO ADMINISTER A DOSE OF NALOXONE

Devices, systems and methods for medicament delivery
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Patent Expiration: ⤷  Sign Up

Devices, systems and methods for medicament delivery
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Patent Expiration: ⤷  Sign Up


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Devices, systems and methods for medicament delivery
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Devices, systems and methods for medicament delivery
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Devices, systems and methods for medicament delivery
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Devices, systems and methods for medicament delivery
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Devices, systems and methods for medicament delivery
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Devices, systems, and methods for medicament delivery
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Devices, systems and methods for medicament delivery
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Medicament delivery device for administration of opioid antagonists including formulations for naloxone
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Medicament delivery device for administration of opioid antagonists including formulations for naloxone
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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

Devices, systems and methods for medicament delivery
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Medicament delivery device for administration of opioid antagonists including formulations for naloxone
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Kaleo Inc NALOXONE HYDROCHLORIDE (AUTOINJECTOR) naloxone hydrochloride SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 215457-001 Feb 28, 2022 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Kaleo Inc NALOXONE HYDROCHLORIDE (AUTOINJECTOR) naloxone hydrochloride SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 215457-001 Feb 28, 2022 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Kaleo Inc NALOXONE HYDROCHLORIDE (AUTOINJECTOR) naloxone hydrochloride SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 215457-001 Feb 28, 2022 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Kaleo Inc NALOXONE HYDROCHLORIDE (AUTOINJECTOR) naloxone hydrochloride SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 215457-001 Feb 28, 2022 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Kaleo Inc NALOXONE HYDROCHLORIDE (AUTOINJECTOR) naloxone hydrochloride SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 215457-001 Feb 28, 2022 DISCN Yes No ⤷  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 NALOXONE HYDROCHLORIDE (AUTOINJECTOR)

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

Country Patent Number Title Estimated Expiration
United Kingdom 0822532 ⤷  Sign Up
United Kingdom 2477046 An auto-injector to mix and/or create an injectable medicament from two or more separate medicaments. ⤷  Sign Up
Japan 5277157 ⤷  Sign Up
New Zealand 555256 Housing, typically similar to credit card size, with compressed gas container, medicament container(s) for user to inject medicament ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2008064092 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for NALOXONE HYDROCHLORIDE (AUTOINJECTOR)

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1685839 92292 Luxembourg ⤷  Sign Up 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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