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 are two patents 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-seven 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.
US Patents and Regulatory Information for REZENOPY
REZENOPY is protected by two 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 | Y | ⤷ 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 | |
| Australia | 2021217164 | ⤷ Start Trial | |
| Canada | 3166250 | ⤷ Start Trial | |
| European Patent Office | 4100012 | ⤷ 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 |
