Naloxone Hydrochloride (autoinjector) Patent Expiration

Naloxone Hydrochloride (autoinjector) is a drug owned by Kaleo Inc. It is protected by 20 US drug patents filed from 2022 to 2023 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be May 24, 2031. Details of Naloxone Hydrochloride (autoinjector)'s patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10143792 Medicament delivery device for administration of opioid antagonists including formulations for naloxone
May, 2031

(6 years from now)

Active
US9474869 Medicament delivery device for administration of opioid antagonists including formulations for naloxone
Feb, 2031

(6 years from now)

Active
US10322239 Medicament delivery device for administration of opioid antagonists including formulations for naloxone
Feb, 2031

(6 years from now)

Active
US9814838 Medicament delivery device for administration of opioid antagonists including formulations for naloxone
Feb, 2031

(6 years from now)

Active
US8939943 Medicament delivery device for administration of opioid antagonists including formulations for naloxone
Feb, 2031

(6 years from now)

Active
US9022022 Medicament delivery device for administration of opioid antagonists including formulations for naloxone
Feb, 2031

(6 years from now)

Active
US7947017 Devices, systems and methods for medicament delivery
Mar, 2028

(3 years from now)

Active
US11590286 Devices, systems and methods for medicament delivery
Dec, 2026

(2 years from now)

Active
US10335549 Devices, systems and methods for medicament delivery
Apr, 2025

(6 months from now)

Active
US8016788 Devices, systems and methods for medicament delivery
Mar, 2025

(5 months from now)

Active
US7731690 Devices, systems and methods for medicament delivery
Jan, 2025

(3 months from now)

Active
US10314977 Devices, systems and methods for medicament delivery
Nov, 2024

(a month from now)

Active
US9056170 Devices, systems and methods for medicament delivery
Nov, 2024

(a month from now)

Active
US8608698 Devices, systems and methods for medicament delivery
Nov, 2024

(a month from now)

Active
US8313466 Devices, systems and methods for medicament delivery
Nov, 2024

(a month from now)

Active
US10737028 Devices, systems and methods for medicament delivery
Nov, 2024

(a month from now)

Active
US9737669 Devices, systems and methods for medicament delivery
Nov, 2024

(a month from now)

Active
US8425462 Devices, systems, and methods for medicament delivery
Nov, 2024

(a month from now)

Active
US8361029 Devices, systems and methods for medicament delivery
Nov, 2024

(a month from now)

Active
US7918823 Devices, systems and methods for medicament delivery
Nov, 2024

(a month from now)

Active


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Naloxone Hydrochloride (autoinjector)'s patents.

Given below is the list of recent legal activities going on the following patents of Naloxone Hydrochloride (autoinjector).

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 12th Year, Large Entity 20 May, 2024 US8313466
Payment of Maintenance Fee, 8th Year, Large Entity 25 Apr, 2024 US9474869
Maintenance Fee Reminder Mailed 01 Apr, 2024 US10737028
Expire Patent 24 Jul, 2023 US9056170
Expire Patent 08 May, 2023 US7918823
Payment of Maintenance Fee, 12th Year, Large Entity 13 Mar, 2023 US8016788
Patent Issue Date Used in PTA Calculation 28 Feb, 2023 US11590286
Recordation of Patent Grant Mailed 28 Feb, 2023 US11590286
Email Notification 11 Feb, 2023 US11590286
Issue Notification Mailed 08 Feb, 2023 US11590286

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US patents provide insights into the exclusivity only within the United States, but Naloxone Hydrochloride (autoinjector) is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Naloxone Hydrochloride (autoinjector)'s family patents as well as insights into ongoing legal events on those patents.

Naloxone Hydrochloride (autoinjector)'s Family Patents

Naloxone Hydrochloride (autoinjector) has patent protection in a total of 15 countries. It's US patent count contributes only to 49.8% of its total global patent coverage. 1 country has all of their patents expired or invalidated which has opened up potential generic launch opportunities in this particular country. Click below to unlock the full patent family tree for Naloxone Hydrochloride (autoinjector).

Family Patents

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Generic Launch

Generic Release Date:

Naloxone Hydrochloride (autoinjector)'s generic launch date based on the expiry of its last outstanding patent is estimated to be May 24, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Naloxone Hydrochloride (autoinjector) Generics:

Naloxone Hydrochloride is the generic name for the brand Naloxone Hydrochloride (autoinjector). 29 different companies have already filed for the generic of Naloxone Hydrochloride (autoinjector), with Igi Labs Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Naloxone Hydrochloride (autoinjector)'s generic

Alternative Brands for Naloxone Hydrochloride (autoinjector)

Naloxone Hydrochloride (autoinjector) which is used for reversing opioid overdose., has several other brand drugs in the same treatment category and using the same active ingredient (Naloxone Hydrochloride). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.

Drug Owner Drug Name Treatment Area
Kaleo Inc
Evzio

(uses Naloxone Hydrochloride)

Used for opioid overdose reversal.
Evzio (autoinjector)

(uses Naloxone Hydrochloride)

used for reversing opioid overdose.

Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Naloxone Hydrochloride. Given below is the list of those drugs and companies owning them.

Drug Owner Drug Name
Bdsi
Bunavail
Emergent
Narcan
Harm Reduction Therp
Rivive
Hikma
Kloxxado
Indivior
Suboxone
Orexo Us Inc
Zubsolv
Purdue Pharma Lp
Targiniq
Zmi Pharma
Zimhi


Apart from brand drugs containing the same ingredient, some generics have also been filed for Naloxone Hydrochloride, Naloxone Hydrochloride (autoinjector)'s active ingredient. Check the complete list of approved generic manufacturers for Naloxone Hydrochloride (autoinjector)





About Naloxone Hydrochloride (autoinjector)

Naloxone Hydrochloride (Autoinjector) is a drug owned by Kaleo Inc. It is used for reversing opioid overdose. Naloxone Hydrochloride (Autoinjector) uses Naloxone Hydrochloride as an active ingredient. Naloxone Hydrochloride (Autoinjector) was launched by Kaleo Inc in 2022.

Approval Date:

Naloxone Hydrochloride (autoinjector) was approved by FDA for market use on 28 February, 2022.

Active Ingredient:

Naloxone Hydrochloride (autoinjector) uses Naloxone Hydrochloride as the active ingredient. Check out other Drugs and Companies using Naloxone Hydrochloride ingredient

Treatment:

Naloxone Hydrochloride (autoinjector) is used for reversing opioid overdose.

Dosage:

Naloxone Hydrochloride (autoinjector) is available in solution form for intramuscular, subcutaneous use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
10MG/0.4ML (10MG/0.4ML) SOLUTION Discontinued INTRAMUSCULAR, SUBCUTANEOUS