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 these, 8 drug patents are active and 12 have expired. 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
(5 years from now) | Active |
| US8939943 | Medicament delivery device for administration of opioid antagonists including formulations for naloxone |
Feb, 2031
(5 years from now) | Active |
| US10322239 | Medicament delivery device for administration of opioid antagonists including formulations for naloxone |
Feb, 2031
(5 years from now) | Active |
| US9474869 | Medicament delivery device for administration of opioid antagonists including formulations for naloxone |
Feb, 2031
(5 years from now) | Active |
| US9814838 | Medicament delivery device for administration of opioid antagonists including formulations for naloxone |
Feb, 2031
(5 years from now) | Active |
| US9022022 | Medicament delivery device for administration of opioid antagonists including formulations for naloxone |
Feb, 2031
(5 years from now) | Active |
| US7947017 | Devices, systems and methods for medicament delivery |
Mar, 2028
(2 years from now) | Active |
| US11590286 | Devices, systems and methods for medicament delivery |
Dec, 2026
(1 year, 1 month from now) | Active |
| US10335549 | Devices, systems and methods for medicament delivery |
Apr, 2025
(5 months ago) |
Expired
|
| US8016788 | Devices, systems and methods for medicament delivery |
Mar, 2025
(7 months ago) |
Expired
|
| US7731690 | Devices, systems and methods for medicament delivery |
Jan, 2025
(9 months ago) |
Expired
|
| US8361029 | Devices, systems and methods for medicament delivery |
Nov, 2024
(11 months ago) |
Expired
|
| US9056170 | Devices, systems and methods for medicament delivery |
Nov, 2024
(11 months ago) |
Expired
|
| US8608698 | Devices, systems and methods for medicament delivery |
Nov, 2024
(11 months ago) |
Expired
|
| US8313466 | Devices, systems and methods for medicament delivery |
Nov, 2024
(11 months ago) |
Expired
|
| US10737028 | Devices, systems and methods for medicament delivery |
Nov, 2024
(11 months ago) |
Expired
|
| US9737669 | Devices, systems and methods for medicament delivery |
Nov, 2024
(11 months ago) |
Expired
|
| US8425462 | Devices, systems, and methods for medicament delivery |
Nov, 2024
(11 months ago) |
Expired
|
| US7918823 | Devices, systems and methods for medicament delivery |
Nov, 2024
(11 months ago) |
Expired
|
| US10314977 | Devices, systems and methods for medicament delivery |
Nov, 2024
(11 months ago) |
Expired
|
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.
Latest 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 |
|---|---|---|
 | ||
| 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
Critical | 01 Apr, 2024 | US10737028 |
| Expire Patent
Critical | 24 Jul, 2023 | US9056170 |
| Expire Patent
Critical | 08 May, 2023 | US7918823 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 13 Mar, 2023 | US8016788 |
| Patent Issue Date Used in PTA Calculation
Critical | 28 Feb, 2023 | US11590286 |
| Recordation of Patent Grant Mailed
Critical | 28 Feb, 2023 | US11590286 |
| Email Notification
Critical | 11 Feb, 2023 | US11590286 |
| Issue Notification Mailed
Critical | 08 Feb, 2023 | US11590286 |
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
Explore Our Curated Drug Screens
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) Generic API suppliers:
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 |
| |||||
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 |
| |
| Emergent |
| |
| Harm Reduction Therp |
| |
| Hikma |
| |
| Indivior |
| |
| Orexo Us Inc |
| |
| Purdue Pharma Lp |
| |
| Zmi Pharma |
|
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 |