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Last Updated: April 26, 2024

NALOXONE HYDROCHLORIDE (AUTOINJECTOR) Drug Patent Profile


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

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. Thirty 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)

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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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Patent Expiration: ⤷  Try a Trial
Patented Use: USE OF A DELIVERY DEVICE TO DELIVER A DOSE OF NALOXONE

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


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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: ⤷  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

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

Medicament delivery device for administration of opioid antagonists including formulations for naloxone
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  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
Kaleo Inc NALOXONE HYDROCHLORIDE (AUTOINJECTOR) naloxone hydrochloride SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 215457-001 Feb 28, 2022 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Kaleo Inc NALOXONE HYDROCHLORIDE (AUTOINJECTOR) naloxone hydrochloride SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 215457-001 Feb 28, 2022 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Kaleo Inc NALOXONE HYDROCHLORIDE (AUTOINJECTOR) naloxone hydrochloride SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 215457-001 Feb 28, 2022 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Kaleo Inc NALOXONE HYDROCHLORIDE (AUTOINJECTOR) naloxone hydrochloride SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 215457-001 Feb 28, 2022 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Kaleo Inc NALOXONE HYDROCHLORIDE (AUTOINJECTOR) naloxone hydrochloride SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 215457-001 Feb 28, 2022 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Kaleo Inc NALOXONE HYDROCHLORIDE (AUTOINJECTOR) naloxone hydrochloride SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 215457-001 Feb 28, 2022 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 NALOXONE HYDROCHLORIDE (AUTOINJECTOR)

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

Country Patent Number Title Estimated Expiration
Canada 2594627 DISPOSITIFS, SYSTEMES ET PROCEDES POUR ADMINISTRER UN MEDICAMENT (DEVICES, SYSTEMS, AND METHODS FOR MEDICAMENT DELIVERY) ⤷  Try a Trial
Australia 2006210865 Devices, systems, and methods for medicament delivery ⤷  Try a Trial
Japan 2014012214 DEVICE, SYSTEM AND METHOD FOR MEDICAMENT DELIVERY ⤷  Try a Trial
Canada 2724069 DISPOSITIF DE DISTRIBUTION DE MEDICAMENT COMPRENANT UN SYSTEME DE CIRCUIT ELECTRONIQUE (MEDICAMENT DELIVERY DEVICE HAVING AN ELECTRONIC CIRCUIT SYSTEM) ⤷  Try a Trial
United Kingdom 201316340 ⤷  Try a Trial
Hong Kong 1123758 DEVICES, SYSTEMS AND METHODS FOR MEDICAMENT DELIVERY ⤷  Try a Trial
>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 ⤷  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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