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 Rivive, Evzio (Autoinjector), Rextovy, Zimhi, Kloxxado, Evzio, Naloxone Hydrochloride (Autoinjector), Rezenopy. 36 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
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 Kaleo Inc
Evzio (autoinjector) US10335549 Devices, systems and methods for medicament delivery Apr 30, 2025 Kaleo Inc
Naloxone Hydrochloride (autoinjector) US10335549 Devices, systems and methods for medicament delivery Apr 30, 2025 Kaleo Inc
Evzio US8016788 Devices, systems and methods for medicament delivery Mar 21, 2025 Kaleo Inc
Evzio (autoinjector) US8016788 Devices, systems and methods for medicament delivery Mar 21, 2025 Kaleo Inc
Naloxone Hydrochloride (autoinjector) US8016788 Devices, systems and methods for medicament delivery Mar 21, 2025 Kaleo Inc
Evzio US7731690 Devices, systems and methods for medicament delivery Jan 15, 2025 Kaleo Inc
Evzio (autoinjector) US7731690 Devices, systems and methods for medicament delivery Jan 15, 2025 Kaleo Inc
Naloxone Hydrochloride (autoinjector) US7731690 Devices, systems and methods for medicament delivery Jan 15, 2025 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

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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 Amneal Pharmaceuticals Llc and was approved on Apr 23, 2024.

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


1. ABRAXIS PHARM

Abraxis Pharmaceutical Products has filed for 3 different strengths of generic version for Naloxone Hydrochloride. Given below are the details of the strengths of this generic introduced by Abraxis Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.02MG/ML

injectable Discontinued INJECTION N/A Nov 17, 1986
0.4MG/ML

injectable Discontinued INJECTION N/A Nov 17, 1986
1MG/ML

injectable Discontinued INJECTION N/A Dec 16, 1988





2. ACCORD HLTHCARE

Accord Healthcare Inc has filed for 2 different strengths of generic version for Naloxone Hydrochloride. Given below are the details of the strengths of this generic introduced by Accord Hlthcare.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1MG/ML

injectable Prescription INJECTION AP Oct 26, 2022
0.4MG/ML

injectable Prescription INJECTION AP Oct 26, 2022





3. AMNEAL

Amneal Pharmaceuticals Llc has filed for 1 generic for Naloxone Hydrochloride. Given below are the details of the strengths of this generic introduced by Amneal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
4MG/SPRAY

spray, metered Over the counter NASAL N/A Apr 23, 2024


Manufacturing Plant Locations
New

Amneal's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Amneal as present at those locations.

Country City Firm Name
United States
Brookhaven Amneal Pharmaceuticals of New York, LLC
East Hanover Amneal Pharmaceuticals LLC
Paterson Amneal Pharmaceuticals, Llc
Branchburg Amneal Pharmaceuticals, LLC
Bridgewater Amneal Complex Products Research LLC
Hauppauge Amneal Pharmaceuticals of New York, LLC
Glasgow Amneal Pharmaceuticals LLC
Piscataway Amneal Pharmaceuticals, LLC
India
Matoda Amneal Pharmaceuticals Private Ltd.
Hyderabad Amneal Oncology Private Limited
Tal Bavla, Ahmedabad Amneal Pharmaceuticals Pvt. Ltd.
Ahmedabad Amneal Pharmaceuticals Private Ltd.





4. ASTRAZENECA

Astrazeneca Lp has filed for 1 generic for Naloxone Hydrochloride. Given below are the details of the strengths of this generic introduced by Astrazeneca.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.02MG/ML

injectable Discontinued INJECTION N/A Apr 11, 1989


Manufacturing Plant Locations
New

Astrazeneca's manufacturing plants are situated in 5 countries - Sweden, France, Germany, United States, Netherlands. Given below are the details of these plant locations as well as the firm names of Astrazeneca as present at those locations.

Country City Firm Name
Sweden
Sodertalje AstraZeneca AB
France
Dordogne AstraZeneca Dunkerque Production (AZDP)
Germany
Wedel AstraZeneca GmbH
United States
Wilmington AstraZeneca Pharmaceuticals LP
Denver AstraZeneca Pharmaceuticals LP
Westborough AstraZeneca LP
Coppell AstraZeneca Pharmaceuticals, LP
Gaithersburg AstraZeneca Pharmaceuticals LP
Newark AstraZeneca Pharmaceuticals, LP
Redwood City AstraZeneca Pharmaceuticals LP
Mount Vernon AstraZeneca Pharmaceuticals LP
Philadelphia AstraZeneca Pharmaceuticals LP
Frederick AstraZeneca Pharmaceuticals LP
San Diego AstraZeneca, PLC
Netherlands
Nijmegen AstraZeneca Nijmegen B.V.





5. BAXTER HLTHCARE CORP

Baxter Healthcare Corp has filed for 1 generic for Naloxone Hydrochloride. Given below are the details of the strengths of this generic introduced by Baxter Hlthcare Corp.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.4MG/ML

injectable Prescription INJECTION AP Nov 7, 2022





6. BPI LABS

Bpi Labs Llc has filed for 1 generic for Naloxone Hydrochloride. Given below are the details of the strengths of this generic introduced by Bpi Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1MG/ML

injectable Prescription INJECTION AP Oct 6, 2023


Manufacturing Plant Locations
New

Bpi Labs's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Bpi Labs as present at those locations.

Country City Firm Name
United States
Evanston BPI Labs





7. BRISTOL MYERS SQUIBB

Bristol Myers Squibb Pharma Co has filed for 2 different strengths of generic version for Naloxone Hydrochloride. All of these versions come by the name NARCAN. Given below are the details of the strengths of this generic introduced by Bristol Myers Squibb.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.4MG/ML

injectable Discontinued INJECTION N/A Jul 28, 1988
1MG/ML

injectable Discontinued INJECTION N/A Jul 28, 1988


Manufacturing Plant Locations
New

Bristol Myers Squibb's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Bristol Myers Squibb as present at those locations.

Country City Firm Name
United States
Catano Bristol Myers Squibb Pr
Princeton Bristol Myers Squibb
Plainsboro Bristol Myers Squibb Company
Mayaguez Bristol Myers Squibb Caribbean Company





8. CHARTWELL RX

Chartwell Rx Sciences Llc has filed for 1 generic for Naloxone Hydrochloride. Given below are the details of the strengths of this generic introduced by Chartwell Rx.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.4MG/ML

injectable Discontinued INJECTION N/A Dec 17, 2018





9. DR REDDYS

Dr Reddys Laboratories Ltd has filed for 1 generic for Naloxone Hydrochloride. Given below are the details of the strengths of this generic introduced by Dr Reddys.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1MG/ML

injectable Prescription INJECTION AP Mar 16, 2020





10. ENDO OPERATIONS

Endo Operations Ltd has filed for 1 generic for Naloxone Hydrochloride. Given below are the details of the strengths of this generic introduced by Endo Operations.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1MG/ML

injectable Prescription INJECTION AP Jul 29, 2022





11. EUGIA PHARMA

Eugia Pharma Specialities Ltd has filed for 2 different strengths of generic version for Naloxone Hydrochloride. Given below are the details of the strengths of this generic introduced by Eugia Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.4MG/ML

injectable Prescription INJECTION AP Nov 4, 2019
1MG/ML

injectable Prescription INJECTION AP Jan 14, 2021


Manufacturing Plant Locations
New

Eugia Pharma's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Eugia Pharma as present at those locations.

Country City Firm Name
India
Medchal-Malkajgiri District EUGIA Pharma Specialities Limited
Riico Industrial Area EUGIA Pharma Specialities Limited
Pashamylaram Eugia Pharma Specialities Limited





12. FRESENIUS KABI USA

Fresenius Kabi Usa Llc has filed for 2 different strengths of generic version for Naloxone Hydrochloride. Given below are the details of the strengths of this generic introduced by Fresenius Kabi Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1MG/ML

injectable Prescription INJECTION AP Apr 2, 2024
0.4MG/ML

injectable Prescription INJECTION AP Apr 2, 2024


Manufacturing Plant Locations
New

Fresenius Kabi Usa's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Fresenius Kabi Usa as present at those locations.

Country City Firm Name
United States
Melrose Park Fresenius Kabi USA LLC
Grand Island Fresenius Kabi USA, LLC
Melrose Park Fresenius Kabi USA, LLC
Lake Zurich Fresenius Kabi USA, LLC
Bensenville Fresenius Kabi USA LLC (FK USA)
Skokie Fresenius Kabi USA LLC
North Andover Fresenius Kabi USA, LLC
Wilson Fresenius Kabi USA, LLC





13. HIKMA

Hikma Pharmaceuticals Usa Inc has filed for 3 different strengths of generic version for Naloxone Hydrochloride. Given below are the details of the strengths of this generic introduced by Hikma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.4MG/ML

injectable Prescription INJECTION AP Mar 7, 2024
1MG/ML

injectable Prescription INJECTION AP Jun 10, 2022
0.02MG/ML

injectable Discontinued INJECTION N/A May 24, 1988


Manufacturing Plant Locations
New

Hikma's manufacturing plants are situated in 3 countries - United States, Portugal, Jordan. Given below are the details of these plant locations as well as the firm names of Hikma as present at those locations.

Country City Firm Name
United States
Eatontown Hikma Pharmaceuticals USA, Inc.
Carlsbad Hikma Cali Inc. DBA Leucadia Pharmaceuticals
Cherry Hill Hikma Pharmaceuticals USA Inc.
Dayton Hikma Injectables USA Inc
Portugal
Terrugem Snt Hikma Farmaceutica, (Portugal) S.A.
Jordan
Amman Hikma Pharmaceuticals LLC





14. HOSPIRA

Hospira Inc has filed for 2 different strengths of generic version for Naloxone Hydrochloride. Given below are the details of the strengths of this generic introduced by Hospira.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.4MG/ML

(reference standard)

injectable Prescription INJECTION AP Jan 7, 1987
0.02MG/ML

injectable Discontinued INJECTION N/A Jan 16, 1987


Manufacturing Plant Locations
New

Hospira's manufacturing plants are situated in 3 countries - Australia, United States, Dominican Republic (the). Given below are the details of these plant locations as well as the firm names of Hospira as present at those locations.

Country City Firm Name
Australia
Mulgrave Hospira Australia Pty Ltd.
United States
Pleasant Prairie Hospira Worldwide, LLC d.b.a. Hospira, a Pfizer-owned Company
Clayton Hospira, Inc.
Morgan Hill Hospira Inc
Rocky Mount Hospira, Inc.
Lake Forest Hospira Inc
Mcpherson Hospira, Inc., A Pfizer Company
Dominican Republic (the)
Haina, San Cristobal Hospira, Ltd.





15. IGI LABS INC

Igi Laboratories Inc has filed for 3 different strengths of generic version for Naloxone Hydrochloride. Given below are the details of the strengths of this generic introduced by Igi Labs Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.4MG/ML

injectable Discontinued INJECTION N/A Apr 11, 1989
0.02MG/ML

injectable Discontinued INJECTION N/A Apr 11, 1989
1MG/ML

injectable Discontinued INJECTION N/A Apr 11, 1989





16. INTL MEDICATION

International Medication Systems Ltd has filed for 2 different strengths of generic version for Naloxone Hydrochloride. Given below are the details of the strengths of this generic introduced by Intl Medication.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.4MG/ML

injectable Discontinued INJECTION N/A Sep 24, 1986
1MG/ML

injectable Discontinued INJECTION N/A Apr 27, 1988





17. MANKIND PHARMA

Mankind Pharma Ltd has filed for 1 generic for Naloxone Hydrochloride. Given below are the details of the strengths of this generic introduced by Mankind Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.4MG/ML

injectable Prescription INJECTION AP Feb 29, 2024


Manufacturing Plant Locations
New

Mankind Pharma's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Mankind Pharma as present at those locations.

Country City Firm Name
India
Imt Manesar Mankind Pharma Limited
Paonta Sahib Mankind Pharma Limited





18. MARSAM PHARMS LLC

Marsam Pharmaceuticals Llc has filed for 1 generic for Naloxone Hydrochloride. Given below are the details of the strengths of this generic introduced by Marsam Pharms Llc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.4MG/ML

injectable Discontinued INJECTION N/A Jul 19, 1988





19. MYLAN INSTITUTIONAL

Mylan Institutional Llc has filed for 1 generic for Naloxone Hydrochloride. Given below are the details of the strengths of this generic introduced by Mylan Institutional.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.4MG/ML

injectable Prescription INJECTION AP Jun 29, 2016


Manufacturing Plant Locations
New

Mylan Institutional's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Mylan Institutional as present at those locations.

Country City Firm Name
United States
Rockford Mylan Institutional, Inc.





20. MYLAN LABS LTD

Mylan Laboratories Ltd has filed for 1 generic for Naloxone Hydrochloride. Given below are the details of the strengths of this generic introduced by Mylan Labs Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1MG/ML

injectable Prescription INJECTION AP Jun 9, 2022





21. PADAGIS ISRAEL

Padagis Israel Pharmaceuticals Ltd has filed for 1 generic for Naloxone Hydrochloride. Given below are the details of the strengths of this generic introduced by Padagis Israel.

Strength Dosage Form Availability Application Pathway TE code Launch Date
4MG/SPRAY

spray, metered Over the counter NASAL N/A Jun 21, 2022


Manufacturing Plant Locations
New

Padagis Israel's manufacturing plants are situated in 1 country - Israel. Given below are the details of these plant locations as well as the firm names of Padagis Israel as present at those locations.

Country City Firm Name
Israel
Yerucham Padagis Israel Pharmaceuticals Ltd.





22. PAR STERILE PRODUCTS

Par Sterile Products Llc has filed for 1 generic for Naloxone Hydrochloride. Given below are the details of the strengths of this generic introduced by Par Sterile Products.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.4MG/ML

injectable Discontinued INJECTION N/A Jan 17, 2020


Manufacturing Plant Locations
New

Par Sterile Products's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Par Sterile Products as present at those locations.

Country City Firm Name
United States
Parsippany Par Sterile Products LLC DBA JHP Pharmaceuticals, LLC





23. RISING

Rising Pharma Holdings Inc has filed for 1 generic for Naloxone Hydrochloride. Given below are the details of the strengths of this generic introduced by Rising.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.4MG/ML

injectable Prescription INJECTION AP Mar 14, 2017


Manufacturing Plant Locations
New

Rising's manufacturing plants are situated in 3 countries - United States, Mexico, India. Given below are the details of these plant locations as well as the firm names of Rising as present at those locations.

Country City Firm Name
United States
Rising Sun Rising Sun Veterinary Clinic
Mount Morris Rising Creek Bakery LLC
Livingston Risingsun Iodine Products Corp.
Saddle Brook Rising Pharmaceuticals, Inc.
Phoenix Rising Sun Farms Inc
Flagstaff Rising High Enterprises, LLC (DBA RisingHy)
Fort Bragg Rising Tide Sea Vegetables
Decatur Rising Pharma Holdings, Inc
East Brunswick Rising Pharma Holding, Inc.
Mexico
Pueblo San Clemente RISING FARMS SAPI DE CV
India
Ahmedabad Rising Retina Clinic





24. SMITH AND NEPHEW

Smith And Nephew Solopak Div Smith And Nephew has filed for 2 different strengths of generic version for Naloxone Hydrochloride. Given below are the details of the strengths of this generic introduced by Smith And Nephew.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.4MG/ML

injectable Discontinued INJECTION N/A Nov 17, 1987
0.02MG/ML

injectable Discontinued INJECTION N/A Nov 17, 1987


Manufacturing Plant Locations
New

Smith And Nephew's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Smith And Nephew as present at those locations.

Country City Firm Name
United States
Goodlettsville Smith and Nephew





25. SOLOPAK

Solopak Medical Products Inc has filed for 2 different strengths of generic version for Naloxone Hydrochloride. Given below are the details of the strengths of this generic introduced by Solopak.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.02MG/ML

injectable Discontinued INJECTION N/A Nov 17, 1987
0.4MG/ML

injectable Discontinued INJECTION N/A Nov 17, 1987





26. SOMERSET THERAPS LLC

Somerset Therapeutics Llc has filed for 1 generic for Naloxone Hydrochloride. Given below are the details of the strengths of this generic introduced by Somerset Theraps Llc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.4MG/ML

injectable Prescription INJECTION AP Aug 8, 2017





27. TEVA PHARMS USA

Teva Pharmaceuticals Usa Inc has filed for 1 generic for Naloxone Hydrochloride. Given below are the details of the strengths of this generic introduced by Teva Pharms Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
4MG/SPRAY

spray, metered Over the counter NASAL N/A Apr 19, 2019





28. WATSON LABS

Watson Laboratories Inc has filed for 1 generic for Naloxone Hydrochloride. Given below are the details of the strengths of this generic introduced by Watson Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.4MG/ML

injectable Discontinued INJECTION N/A Nov 18, 1987





29. WYETH AYERST

Wyeth Ayerst Laboratories has filed for 2 different strengths of generic version for Naloxone Hydrochloride. All of these versions come by the name NALOXONE. Given below are the details of the strengths of this generic introduced by Wyeth Ayerst.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.02MG/ML

injectable Discontinued INJECTION N/A Sep 24, 1986
0.4MG/ML

injectable Discontinued INJECTION N/A Sep 24, 1986