You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: June 14, 2024

Naloxone hydrochloride - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic 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, Adamis Pharms Corp, 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. Thirty-six suppliers are listed for this compound.

Recent Clinical Trials for naloxone hydrochloride

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

SponsorPhase
Johns Hopkins UniversityPhase 3
Cure Addiction NowPhase 3
Johns Hopkins UniversityPhase 4

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 ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Kaleo Inc EVZIO naloxone hydrochloride SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 205787-001 Apr 3, 2014 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Sanofi Aventis Us TALWIN NX naloxone hydrochloride; pentazocine hydrochloride TABLET;ORAL 018733-001 Dec 16, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Solopak NALOXONE HYDROCHLORIDE naloxone hydrochloride INJECTABLE;INJECTION 071672-001 Nov 17, 1987 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
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 EVZIO naloxone hydrochloride SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 205787-001 Apr 3, 2014 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  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
New Zealand 560516 A delivery system where a medicant is automatically delivered on activation as well as a recorded instruction ⤷  Sign Up
China 101087625 Devices, systems and methods for medicament delivery ⤷  Sign Up
Hungary E036465 ⤷  Sign Up
Mexico 2010012334 DISPOSITIVO DE ADMINISTRACION DE MEDICAMENTOS PROVISTO DE UN SISTEMA DE CIRCUITOS ELECTRONICOS. (MEDICAMENT DELIVERY DEVICE HAVING AN ELECTRONIC CIRCUIT SYSTEM.) ⤷  Sign Up
European Patent Office 2099434 DISPOSITIFS ET SYSTÈMES POUR L'ADMINISTRATION DE MÉDICAMENTS (DEVICES AND SYSTEMS FOR MEDICAMENT DELIVERY) ⤷  Sign Up
Austria 16553 ⤷  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

Make Better Decisions: Try a trial or see plans & pricing

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.