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Last Updated: March 28, 2024

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 thirteen branded drugs marketed by Hikma, Wyeth Ayerst, Abraxis Pharm, Accord Hlthcare, Astrazeneca, Baxter Hlthcare Corp, Bpi Labs, Chartwell Rx, Dr Reddys, Eugia Pharma, Hospira, Igi Labs Inc, Intl Medication, 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, Adamis Pharms Corp, Padagis Israel, Teva Pharms Usa, Emergent, Amphastar Pharms Inc, Harm Reduction Therp, Purdue Pharma Lp, Lupin, Sun Pharm Inds Ltd, and Sanofi Aventis Us, and is included in eighty-five 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-four patent family members in thirty-eight countries.

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

Recent Clinical Trials for naloxone hydrochloride

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

SponsorPhase
Johns Hopkins UniversityPhase 4
DEKA S.r.l.Phase 4
Nirsum LabsPhase 1

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 naloxone hydrochloride SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 205787-001 Apr 3, 2014 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Hospira NALOXONE HYDROCHLORIDE naloxone hydrochloride INJECTABLE;INJECTION 070253-001 Jan 16, 1987 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Kaleo Inc EVZIO naloxone hydrochloride SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 205787-001 Apr 3, 2014 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Purdue Pharma Lp TARGINIQ naloxone hydrochloride; oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 205777-003 Jul 23, 2014 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
>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
Mexico 2013013276 FORMAS DE DOSIFICACION FARMACEUTICAS INTRANASALES QUE COMPRENDEN NALOXONA. (INTRANASAL PHARMACEUTICAL DOSAGE FORMS COMPRISING NALOXONE.) ⤷  Try a Trial
Denmark 201800034 ⤷  Try a Trial
United Kingdom 2501214 Medicament delivery devices for administration of a medicament within a prefillied syringe ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2006083876 ⤷  Try a Trial
>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 ⤷  Try a Trial 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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