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Last Updated: November 21, 2024

NALOXONE HYDROCHLORIDE - Generic Drug Details


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What are the generic drug sources for naloxone hydrochloride and what is the scope of patent protection?

Naloxone hydrochloride is the generic ingredient in fourteen branded drugs marketed by Hikma, Wyeth Ayerst, Abraxis Pharm, Accord Hlthcare, Astrazeneca, Baxter Hlthcare Corp, Bpi Labs, Chartwell Rx, Dr Reddys, Endo Operations, Eugia Pharma, Fresenius Kabi Usa, Hospira, Igi Labs Inc, Intl Medication, Mankind Pharma, Marsam Pharms Llc, Mylan Institutional, Mylan Labs Ltd, Par Sterile Products, Rising, Smith And Nephew, Solopak, Somerset Theraps Llc, Watson Labs, Adapt, Bristol Myers Squibb, Kaleo Inc, Zmi Pharma, Amneal, Padagis Israel, Teva Pharms Usa, Emergent, Amphastar Pharms Inc, Harm Reduction Therp, Summit Biosci, Purdue Pharma Lp, Lupin, Sun Pharm Inds Ltd, and Sanofi Aventis Us, and is included in eighty-nine NDAs. There are forty-eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Naloxone hydrochloride has two hundred and forty-five patent family members in thirty-eight countries.

There are eight drug master file entries for naloxone hydrochloride. Forty-four suppliers are listed for this compound.

Summary for NALOXONE HYDROCHLORIDE
Recent Clinical Trials for NALOXONE HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Murdoch Childrens Research InstitutePhase 4
Johns Hopkins UniversityPhase 3
Cure Addiction NowPhase 3

See all NALOXONE HYDROCHLORIDE clinical trials

Pharmacology for NALOXONE HYDROCHLORIDE
Drug ClassOpioid Antagonist
Mechanism of ActionOpioid Antagonists
Medical Subject Heading (MeSH) Categories for NALOXONE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for NALOXONE HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
KLOXXADO Nasal Spray naloxone hydrochloride 8 mg/spray 212045 1 2023-03-30
NARCAN Nasal Spray naloxone hydrochloride 2 mg/spray 208411 1 2017-12-28
NARCAN Nasal Spray naloxone hydrochloride 4 mg/spray 208411 1 2016-07-15

US Patents and Regulatory Information for NALOXONE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Kaleo Inc EVZIO (AUTOINJECTOR) naloxone hydrochloride SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 209862-001 Oct 19, 2016 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
Hikma KLOXXADO naloxone hydrochloride SPRAY;NASAL 212045-001 Apr 29, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Watson Labs NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE naloxone hydrochloride; pentazocine hydrochloride TABLET;ORAL 074736-001 Jan 21, 1997 AB RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Abraxis Pharm NALOXONE HYDROCHLORIDE naloxone hydrochloride INJECTABLE;INJECTION 070649-001 Nov 17, 1986 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb NARCAN naloxone hydrochloride INJECTABLE;INJECTION 071084-001 Jul 28, 1988 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for NALOXONE HYDROCHLORIDE

Country Patent Number Title Estimated Expiration
United Kingdom 0713202 ⤷  Sign Up
Israel 229409 צורות מינון רוקחיות תוך אפיות המכילות נאלוקסון (Intranasal pharmaceutical dosage forms comprising naloxone) ⤷  Sign Up
Japan 2014012214 DEVICE, SYSTEM AND METHOD FOR MEDICAMENT DELIVERY ⤷  Sign Up
Mexico 2008012446 DISPOSITIVOS, SISTEMAS Y METODOS PARA ADMINISTRACION DE MEDICAMENTOS. (DEVICES, SYSTEMS AND METHODS FOR MEDICAMENT DELIVERY.) ⤷  Sign Up
Canada 2825600 DISPOSITIFS D'ADMINISTRATION DE MEDICAMENT POUR L'ADMINISTRATION D'UN MEDICAMENT A L'INTERIEUR D'UNE SERINGUE PRE-REMPLIE (MEDICAMENT DELIVERY DEVICES FOR ADMINISTRATION OF A MEDICAMENT WITHIN A PREFILLED SYRINGE) ⤷  Sign Up
Canada 2743303 APPAREIL ET PROCEDES POUR L'AUTO-ADMINISTRATION DE VACCINS ET D'AUTRES MEDICAMENTS (APPARATUS AND METHODS FOR SELF-ADMINISTRATION OF VACCINES AND OTHER MEDICAMENTS) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for NALOXONE HYDROCHLORIDE

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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