naloxone hydrochloride (autoinjector) Drug Patent Profile
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Which patents cover Naloxone Hydrochloride (autoinjector), 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. Forty-five 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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Summary for naloxone hydrochloride (autoinjector)
| International Patents: | 141 |
| US Patents: | 18 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 2 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for naloxone hydrochloride (autoinjector) |
| DailyMed Link: | naloxone hydrochloride (autoinjector) at DailyMed |
-patent-expirations.png "naloxone hydrochloride (autoinjector) drug patent expirations")
Recent Clinical Trials for naloxone hydrochloride (autoinjector)
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Pfizer | Phase 1 |
| National Institute on Drug Abuse (NIDA) | Phase 1 |
See all naloxone hydrochloride (autoinjector) clinical trials
Pharmacology for naloxone hydrochloride (autoinjector)
| Drug Class | Opioid Antagonist |
| Mechanism of Action | Opioid 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
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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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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
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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 |
Expired US Patents for naloxone hydrochloride (autoinjector)
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Kaleo Inc | NALOXONE HYDROCHLORIDE (AUTOINJECTOR) | naloxone hydrochloride | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 215457-001 | Feb 28, 2022 | ⤷ Sign Up | ⤷ Sign Up |
| Kaleo Inc | NALOXONE HYDROCHLORIDE (AUTOINJECTOR) | naloxone hydrochloride | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 215457-001 | Feb 28, 2022 | ⤷ Sign Up | ⤷ Sign Up |
| Kaleo Inc | NALOXONE HYDROCHLORIDE (AUTOINJECTOR) | naloxone hydrochloride | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 215457-001 | Feb 28, 2022 | ⤷ Sign Up | ⤷ Sign Up |
| Kaleo Inc | NALOXONE HYDROCHLORIDE (AUTOINJECTOR) | naloxone hydrochloride | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 215457-001 | Feb 28, 2022 | ⤷ Sign Up | ⤷ Sign Up |
| Kaleo Inc | NALOXONE HYDROCHLORIDE (AUTOINJECTOR) | naloxone hydrochloride | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 215457-001 | Feb 28, 2022 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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 | 2440039 | Devices, systems and methods for medicament delivery | ⤷ Sign Up |
| United Kingdom | 2478085 | Medical Injector Simulation Device | ⤷ Sign Up |
| Denmark | 2285360 | ⤷ Sign Up | |
| Canada | 2926365 | DISPOSITIFS, SYSTEMES ET PROCEDES POUR L'ADMINISTRATION DE MEDICAMENTS (DEVICES, SYSTEMS AND METHODS FOR MEDICAMENT DELIVERY) | ⤷ Sign Up |
| Australia | 2009246525 | Medicament delivery device having an electronic circuit system | ⤷ 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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