Naloxone Hydrochloride Patent Expiration

Naloxone Hydrochloride is used for the emergency treatment of opioid overdose to reverse respiratory and central nervous system depression. It was first introduced by Adapt Pharma Operations Ltd in its drug Narcan on Approved Prior to Jan 1, 1982. Other drugs containing Naloxone Hydrochloride are Rezenopy, Evzio, Naloxone Hydrochloride (Autoinjector), Evzio (Autoinjector), Kloxxado, Zimhi, Rextovy, Rivive. 35 different companies have introduced drugs containing Naloxone Hydrochloride.


Naloxone Hydrochloride Patents

Given below is the list of patents protecting Naloxone Hydrochloride, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Zimhi US11571518 Emergency devices Jun 14, 2041 Zmi Pharma
Zimhi US11027072 Emergency devices May 24, 2039 Zmi Pharma
Evzio US10220158 Devices and methods for delivering opioid antagonists including formulations for naloxone Mar 20, 2035 Kaleo Inc
Evzio (autoinjector) US10220158 Devices and methods for delivering opioid antagonists including formulations for naloxone Mar 20, 2035 Kaleo Inc
Narcan US10085937 Nasal drug products and methods of their use Mar 16, 2035 Emergent
Narcan US9211253 Nasal drug products and methods of their use Mar 16, 2035 Emergent
Narcan US9468747 Nasal drug products and methods of their use Mar 16, 2035 Emergent
Narcan US9480644 Nasal drug products and methods of their use Mar 16, 2035 Emergent
Narcan US9561177 Nasal drug products and methods of their use Mar 16, 2035 Emergent
Narcan US9629965 Nasal drug products and methods of their use Mar 16, 2035 Emergent
Narcan US9707226 Nasal drug products and methods of their use Mar 16, 2035 Emergent
Narcan US9775838 Nasal drug products and methods of their use Mar 16, 2035 Emergent
Kloxxado US10722510 Liquid naloxone spray Aug 26, 2034 Hikma
Kloxxado US10973814 Liquid naloxone spray Aug 26, 2034 Hikma
Kloxxado US11135155 Liquid naloxone spray Aug 26, 2034 Hikma
Kloxxado US11617713 Liquid naloxone spray Aug 26, 2034 Hikma
Kloxxado US11628139 Liquid naloxone spray Aug 26, 2034 Hikma
Kloxxado US11975096 Liquid naloxone spray Aug 26, 2034 Hikma
Evzio US9517307 Devices and methods for delivering opioid antagonists including formulations for naloxone Jul 18, 2034 Kaleo Inc
Evzio (autoinjector) US9517307 Devices and methods for delivering opioid antagonists including formulations for naloxone Jul 18, 2034 Kaleo Inc
Rivive US11020343 Intranasal pharmaceutical dosage forms comprising naloxone May 11, 2032 Harm Reduction Therp
Rivive US11806428 Intranasal pharmaceutical dosage forms comprising naloxone May 11, 2032 Harm Reduction Therp
Evzio US8627816 Medicament delivery device for administration of opioid antagonists including formulations for naloxone Feb 04, 2032 Kaleo Inc
Evzio (autoinjector) US8627816 Medicament delivery device for administration of opioid antagonists including formulations for naloxone Feb 04, 2032 Kaleo Inc
Evzio US10143972 Ultrafiltration membrane and a preparation method thereof May 24, 2031 Kaleo Inc
Evzio (autoinjector) US10143792 Medicament delivery device for administration of opioid antagonists including formulations for naloxone May 24, 2031 Kaleo Inc
Evzio (autoinjector) US10143972 Ultrafiltration membrane and a preparation method thereof May 24, 2031 Kaleo Inc
Naloxone Hydrochloride (autoinjector) US10143792 Medicament delivery device for administration of opioid antagonists including formulations for naloxone May 24, 2031 Kaleo Inc
Evzio US10322239 Medicament delivery device for administration of opioid antagonists including formulations for naloxone Feb 28, 2031 Kaleo Inc
Evzio US8939943 Medicament delivery device for administration of opioid antagonists including formulations for naloxone Feb 28, 2031 Kaleo Inc
Evzio US9022022 Medicament delivery device for administration of opioid antagonists including formulations for naloxone Feb 28, 2031 Kaleo Inc
Evzio US9474869 Medicament delivery device for administration of opioid antagonists including formulations for naloxone Feb 28, 2031 Kaleo Inc
Evzio (autoinjector) US10322239 Medicament delivery device for administration of opioid antagonists including formulations for naloxone Feb 28, 2031 Kaleo Inc
Evzio (autoinjector) US8939943 Medicament delivery device for administration of opioid antagonists including formulations for naloxone Feb 28, 2031 Kaleo Inc
Evzio (autoinjector) US9022022 Medicament delivery device for administration of opioid antagonists including formulations for naloxone Feb 28, 2031 Kaleo Inc
Evzio (autoinjector) US9474869 Medicament delivery device for administration of opioid antagonists including formulations for naloxone Feb 28, 2031 Kaleo Inc
Naloxone Hydrochloride (autoinjector) US10322239 Medicament delivery device for administration of opioid antagonists including formulations for naloxone Feb 28, 2031 Kaleo Inc
Naloxone Hydrochloride (autoinjector) US8939943 Medicament delivery device for administration of opioid antagonists including formulations for naloxone Feb 28, 2031 Kaleo Inc
Naloxone Hydrochloride (autoinjector) US9022022 Medicament delivery device for administration of opioid antagonists including formulations for naloxone Feb 28, 2031 Kaleo Inc
Naloxone Hydrochloride (autoinjector) US9474869 Medicament delivery device for administration of opioid antagonists including formulations for naloxone Feb 28, 2031 Kaleo Inc
Naloxone Hydrochloride (autoinjector) US9814838 Medicament delivery device for administration of opioid antagonists including formulations for naloxone Feb 28, 2031 Kaleo Inc
Evzio US8021344 Medicament delivery device configured to produce an audible output Nov 02, 2029 Kaleo Inc
Evzio (autoinjector) US8021344 Medicament delivery device configured to produce an audible output Nov 02, 2029 Kaleo Inc
Evzio US8223610 Apparatus and method for initializing information recording medium, apparatus and method for recording information, and information recording medium Apr 10, 2029 Kaleo Inc
Evzio US8226610 Medical injector with compliance tracking and monitoring Apr 10, 2029 Kaleo Inc
Evzio (autoinjector) US8226610 Medical injector with compliance tracking and monitoring Apr 10, 2029 Kaleo Inc
Evzio US8231573 Medicament delivery device having an electronic circuit system Nov 25, 2028 Kaleo Inc
Evzio (autoinjector) US8231573 Medicament delivery device having an electronic circuit system Nov 25, 2028 Kaleo Inc
Evzio US7749194 Devices, systems, and methods for medicament delivery Oct 30, 2028 Kaleo Inc
Evzio (autoinjector) US7749194 Devices, systems, and methods for medicament delivery Oct 30, 2028 Kaleo Inc
Evzio US7947017 Devices, systems and methods for medicament delivery Mar 12, 2028 Kaleo Inc
Evzio (autoinjector) US7947017 Devices, systems and methods for medicament delivery Mar 12, 2028 Kaleo Inc
Naloxone Hydrochloride (autoinjector) US7947017 Devices, systems and methods for medicament delivery Mar 12, 2028 Kaleo Inc
Evzio US9724471 Devices, systems, and methods for medicament delivery May 23, 2027 Kaleo Inc
Evzio (autoinjector) US9724471 Devices, systems, and methods for medicament delivery May 23, 2027 Kaleo Inc
Evzio US8206360 Devices, systems and methods for medicament delivery Feb 27, 2027 Kaleo Inc
Evzio (autoinjector) US8206360 Devices, systems and methods for medicament delivery Feb 27, 2027 Kaleo Inc
Evzio US9238108 Medicament delivery device having an electronic circuit system Feb 20, 2027 Kaleo Inc
Evzio (autoinjector) US9238108 Medicament delivery device having an electronic circuit system Feb 20, 2027 Kaleo Inc
Evzio US11590286 Devices, systems and methods for medicament delivery Dec 12, 2026 Kaleo Inc
Evzio (autoinjector) US11590286 Devices, systems and methods for medicament delivery Dec 12, 2026 Kaleo Inc
Naloxone Hydrochloride (autoinjector) US11590286 Devices, systems and methods for medicament delivery Dec 12, 2026 Kaleo Inc
Evzio US10960155 Devices, systems and methods for medicament delivery Jun 25, 2026 Kaleo Inc
Evzio (autoinjector) US10960155 Devices, systems and methods for medicament delivery Jun 25, 2026 Kaleo Inc
Evzio US7731686 Devices, systems and methods for medicament delivery Jun 10, 2026 Kaleo Inc
Evzio (autoinjector) US7731686 Devices, systems and methods for medicament delivery Jun 01, 2026 Kaleo Inc
Evzio US8926594 Devices, systems and methods for medicament delivery Mar 31, 2026 Kaleo Inc
Evzio (autoinjector) US8926594 Devices, systems and methods for medicament delivery Mar 31, 2026 Kaleo Inc
Evzio US9278182 Devices, systems and methods for medicament delivery Feb 01, 2026 Kaleo Inc
Evzio (autoinjector) US9278182 Devices, systems and methods for medicament delivery Feb 01, 2026 Kaleo Inc
Evzio US10335549 Devices, systems and methods for medicament delivery Apr 30, 2025

(Expired)

Kaleo Inc
Evzio (autoinjector) US10335549 Devices, systems and methods for medicament delivery Apr 30, 2025

(Expired)

Kaleo Inc
Naloxone Hydrochloride (autoinjector) US10335549 Devices, systems and methods for medicament delivery Apr 30, 2025

(Expired)

Kaleo Inc
Evzio US8016788 Devices, systems and methods for medicament delivery Mar 21, 2025

(Expired)

Kaleo Inc
Evzio (autoinjector) US8016788 Devices, systems and methods for medicament delivery Mar 21, 2025

(Expired)

Kaleo Inc
Naloxone Hydrochloride (autoinjector) US8016788 Devices, systems and methods for medicament delivery Mar 21, 2025

(Expired)

Kaleo Inc
Evzio US7731690 Devices, systems and methods for medicament delivery Jan 15, 2025

(Expired)

Kaleo Inc
Evzio (autoinjector) US7731690 Devices, systems and methods for medicament delivery Jan 15, 2025

(Expired)

Kaleo Inc
Naloxone Hydrochloride (autoinjector) US7731690 Devices, systems and methods for medicament delivery Jan 15, 2025

(Expired)

Kaleo Inc
Evzio US10314977 Devices, systems and methods for medicament delivery Nov 23, 2024

(Expired)

Kaleo Inc
Evzio US10737028 Devices, systems and methods for medicament delivery Nov 23, 2024

(Expired)

Kaleo Inc
Evzio US7918823 Devices, systems and methods for medicament delivery Nov 23, 2024

(Expired)

Kaleo Inc
Evzio US8313466 Devices, systems and methods for medicament delivery Nov 23, 2024

(Expired)

Kaleo Inc
Evzio US8361029 Devices, systems and methods for medicament delivery Nov 23, 2024

(Expired)

Kaleo Inc
Evzio US8425462 Devices, systems, and methods for medicament delivery Nov 23, 2024

(Expired)

Kaleo Inc
Evzio US8608698 Devices, systems and methods for medicament delivery Nov 23, 2024

(Expired)

Kaleo Inc
Evzio US9056170 Devices, systems and methods for medicament delivery Nov 23, 2024

(Expired)

Kaleo Inc
Evzio US9737669 Devices, systems and methods for medicament delivery Nov 23, 2024

(Expired)

Kaleo Inc
Evzio (autoinjector) US10314977 Devices, systems and methods for medicament delivery Nov 23, 2024

(Expired)

Kaleo Inc
Evzio (autoinjector) US10737028 Devices, systems and methods for medicament delivery Nov 23, 2024

(Expired)

Kaleo Inc
Evzio (autoinjector) US7918823 Devices, systems and methods for medicament delivery Nov 23, 2024

(Expired)

Kaleo Inc
Evzio (autoinjector) US8313466 Devices, systems and methods for medicament delivery Nov 23, 2024

(Expired)

Kaleo Inc
Evzio (autoinjector) US8361029 Devices, systems and methods for medicament delivery Nov 23, 2024

(Expired)

Kaleo Inc
Evzio (autoinjector) US8425462 Devices, systems, and methods for medicament delivery Nov 23, 2024

(Expired)

Kaleo Inc
Evzio (autoinjector) US8608698 Devices, systems and methods for medicament delivery Nov 23, 2024

(Expired)

Kaleo Inc
Evzio (autoinjector) US9056170 Devices, systems and methods for medicament delivery Nov 23, 2024

(Expired)

Kaleo Inc
Evzio (autoinjector) US9737669 Devices, systems and methods for medicament delivery Nov 23, 2024

(Expired)

Kaleo Inc
Naloxone Hydrochloride (autoinjector) US10314977 Devices, systems and methods for medicament delivery Nov 23, 2024

(Expired)

Kaleo Inc
Naloxone Hydrochloride (autoinjector) US10737028 Devices, systems and methods for medicament delivery Nov 23, 2024

(Expired)

Kaleo Inc
Naloxone Hydrochloride (autoinjector) US7918823 Devices, systems and methods for medicament delivery Nov 23, 2024

(Expired)

Kaleo Inc
Naloxone Hydrochloride (autoinjector) US8313466 Devices, systems and methods for medicament delivery Nov 23, 2024

(Expired)

Kaleo Inc
Naloxone Hydrochloride (autoinjector) US8361029 Devices, systems and methods for medicament delivery Nov 23, 2024

(Expired)

Kaleo Inc
Naloxone Hydrochloride (autoinjector) US8425462 Devices, systems, and methods for medicament delivery Nov 23, 2024

(Expired)

Kaleo Inc
Naloxone Hydrochloride (autoinjector) US8608698 Devices, systems and methods for medicament delivery Nov 23, 2024

(Expired)

Kaleo Inc
Naloxone Hydrochloride (autoinjector) US9056170 Devices, systems and methods for medicament delivery Nov 23, 2024

(Expired)

Kaleo Inc
Naloxone Hydrochloride (autoinjector) US9737669 Devices, systems and methods for medicament delivery Nov 23, 2024

(Expired)

Kaleo Inc



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's patents.

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

Activity Date Patent Number
Patent litigations
Patent Issue Date Used in PTA Calculation 07 Nov, 2023 US11806428
Mail Patent eGrant Notification 07 Nov, 2023 US11806428
Recordation of Patent eGrant 07 Nov, 2023 US11806428
Recordation of Patent Grant Mailed 07 Nov, 2023 US11806428
Patent eGrant Notification 07 Nov, 2023 US11806428
Email Notification 07 Nov, 2023 US11806428
Email Notification 19 Oct, 2023 US11806428
Issue Notification Mailed 18 Oct, 2023 US11806428
Application Is Considered Ready for Issue 04 Oct, 2023 US11806428
Dispatch to FDC 04 Oct, 2023 US11806428


Naloxone Hydrochloride's Family Patents

Family Patents

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Naloxone Hydrochloride Generic API Manufacturers

Several generic applications have been filed for Naloxone Hydrochloride. The first generic version for Naloxone Hydrochloride was by Wyeth Ayerst Laboratories and was approved on Sep 24, 1986. And the latest generic version is by Baxter Healthcare Corp and was approved on Jun 3, 2025.

Given below is the list of companies who have filed for Naloxone Hydrochloride generic, along with the locations of their manufacturing plants worldwide.