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Last Updated: February 9, 2023

Naloxone hydrochloride - Generic Drug Details


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

Naloxone hydrochloride is the generic ingredient in eleven branded drugs marketed by Hikma, Wyeth Ayerst, Abraxis Pharm, Accord Hlthcare, Akorn, Anda Repository, Astrazeneca, Baxter Hlthcare Corp, Dr Reddys, Eugia Pharma, Hospira, Igi Labs Inc, Intl Medication, Marsam Pharms Llc, Mylan Institutional, Mylan Labs Ltd, Par Sterile Products, Smith And Nephew, Solopak, Somerset Theraps Llc, Watson Labs, Adapt, Bristol Myers Squibb, Kaleo Inc, Adamis Pharms Corp, Padagis Israel, Teva Pharms Usa, Emergent, Purdue Pharma Lp, Lupin, Sun Pharm Inds Ltd, and Sanofi Aventis Us, and is included in eighty-two NDAs. There are fifty-five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Naloxone hydrochloride has one hundred and ninety-four patent family members in twenty countries.

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

Recent Clinical Trials for naloxone hydrochloride

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

SponsorPhase
Bicycle HealthPhase 4
Icahn School of Medicine at Mount SinaiPhase 3
University of PennsylvaniaEarly Phase 1

See all naloxone hydrochloride clinical trials

Pharmacology for naloxone hydrochloride
Drug ClassOpioid Antagonist
Mechanism of Action Opioid Antagonists
Medical Subject Heading (MeSH) Categories for naloxone hydrochloride
Paragraph IV (Patent) Challenges for NALOXONE HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
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 naloxone hydrochloride SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 205787-001 Apr 3, 2014 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Akorn NALOXONE HYDROCHLORIDE naloxone hydrochloride INJECTABLE;INJECTION 208871-001 Feb 28, 2017 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Purdue Pharma Lp TARGINIQ naloxone hydrochloride; oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 205777-002 Jul 23, 2014 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Kaleo Inc NALOXONE HYDROCHLORIDE (AUTOINJECTOR) naloxone hydrochloride SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 215457-001 Feb 28, 2022 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Kaleo Inc EVZIO (AUTOINJECTOR) naloxone hydrochloride SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 209862-001 Oct 19, 2016 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Abraxis Pharm NALOXONE HYDROCHLORIDE naloxone hydrochloride INJECTABLE;INJECTION 070661-001 Nov 17, 1986 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Canada 3015269 DISPOSITIFS, SYSTEMES ET PROCEDES D'ADMINISTRATION DE MEDICAMENTS (DEVICES, SYSTEMS, AND METHODS FOR MEDICAMENT DELIVERY) See Plans and Pricing
Canada 2827576 DISPOSITIFS D'ADMINISTRATION DE MEDICAMENT DESTINES A L'ADMINISTRATION D'ANTAGONISTES D'OPIOIDE COMPRENANT DES FORMULATIONS POUR LA NALOXONE (MEDICAMENT DELIVERY DEVICE FOR ADMINISTRATION OF OPIOID ANTAGONISTS INCLUDING FORMULATIONS FOR NALOXONE) See Plans and Pricing
Russian Federation 2020112530 НАЗАЛЬНЫЕ ГОТОВЫЕ ЛЕКАРСТВЕННЫЕ ФОРМЫ И СПОСОБЫ ИХ ПРИМЕНЕНИЯ See Plans and Pricing
Japan 5277157 See Plans and Pricing
Japan 2019189631 経鼻薬物製品およびその使用方法 (PERNASAL DRUG PRODUCT AND METHOD OF USING THE SAME) See Plans and Pricing
European Patent Office 2058020 Dispositifs pour l'administration de médicaments (Devices for medicament delivery) See Plans and Pricing
>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 See Plans and Pricing 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.