Last Updated: June 24, 2026

REZENOPY Drug Patent Profile


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Which patents cover Rezenopy, and when can generic versions of Rezenopy launch?

Rezenopy is a drug marketed by Scienture and is included in one NDA. There is one patent protecting this drug.

This drug has four patent family members in four countries.

The generic ingredient in REZENOPY is naloxone hydrochloride. There are twelve drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Rezenopy

A generic version of REZENOPY was approved as naloxone hydrochloride by HOSPIRA on September 24th, 1986.

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Summary for REZENOPY
International Patents:4
US Patents:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Patent Applications: 2,556
What excipients (inactive ingredients) are in REZENOPY?REZENOPY excipients list
DailyMed Link:REZENOPY at DailyMed
Pharmacology for REZENOPY
Drug ClassOpioid Antagonist
Mechanism of ActionOpioid Antagonists

US Patents and Regulatory Information for REZENOPY

REZENOPY is protected by one US patents and one FDA Regulatory Exclusivity.

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Scienture REZENOPY naloxone hydrochloride SPRAY;NASAL 215487-001 Apr 19, 2024 RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Scienture REZENOPY naloxone hydrochloride SPRAY;NASAL 215487-001 Apr 19, 2024 RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start 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 REZENOPY

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

Country Patent Number Title Estimated Expiration
Australia 2021217164 Drug products for intranasal administration and uses thereof ⤷  Start Trial
Canada 3166250 PRODUITS MEDICAMENTEUX DESTINES A ETRE ADMINISTRES PAR VOIE INTRANASALE ET UTILISATIONS ASSOCIEES (DRUG PRODUCTS FOR INTRANASAL ADMINISTRATION AND USES THEREOF) ⤷  Start Trial
European Patent Office 4100012 PRODUITS MÉDICAMENTEUX DESTINÉS À ÊTRE ADMINISTRÉS PAR VOIE INTRANASALE ET UTILISATIONS ASSOCIÉES (DRUG PRODUCTS FOR INTRANASAL ADMINISTRATION AND USES THEREOF) ⤷  Start Trial
World Intellectual Property Organization (WIPO) 2021158957 ⤷  Start Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for REZENOPY

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