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Last Updated: November 27, 2022

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, 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 NDAs. There are sixty-one 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. Twenty-six suppliers are listed for this compound.

Recent Clinical Trials for naloxone hydrochloride

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

SponsorPhase
Icahn School of Medicine at Mount SinaiPhase 3
Royal Victoria Hospital, CanadaPhase 4
Ensysce BiosciencesPhase 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
Purdue Pharma Lp TARGINIQ naloxone hydrochloride; oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 205777-003 Jul 23, 2014 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Somerset Theraps Llc NALOXONE HYDROCHLORIDE naloxone hydrochloride INJECTABLE;INJECTION 207634-001 Jul 26, 2017 AP RX No No See Plans and Pricing See Plans and Pricing 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
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
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
>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 201315737 See Plans and Pricing
Japan 5680852 See Plans and Pricing
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) See Plans and Pricing
Canada 2976873 DISPOSITIFS, SYSTEMES ET PROCEDES POUR ADMINISTRER UN MEDICAMENT (DEVICES, SYSTEMS, AND METHODS FOR MEDICAMENT DELIVERY) See Plans and Pricing
United Kingdom 2471981 Medicament delivery device having an electronic circuit system 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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