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Last Updated: November 21, 2024

NALOXONE Drug Patent Profile


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When do Naloxone patents expire, and what generic alternatives are available?

Naloxone is a drug 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, Amneal, Padagis Israel, Teva Pharms Usa, Kaleo Inc, Lupin, and Sun Pharm Inds Ltd. and is included in seventy-five NDAs. There are eighteen patents protecting this drug.

The generic ingredient in NALOXONE is naloxone hydrochloride; pentazocine hydrochloride. There are twelve drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride; pentazocine hydrochloride profile page.

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Summary for NALOXONE
Drug patent expirations by year for NALOXONE
Drug Prices for NALOXONE

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Recent Clinical Trials for NALOXONE

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

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

See all NALOXONE clinical trials

Pharmacology for NALOXONE
Drug ClassOpioid Antagonist
Mechanism of ActionOpioid Antagonists

US Patents and Regulatory Information for NALOXONE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal NALOXONE HYDROCHLORIDE naloxone hydrochloride SPRAY, METERED;NASAL 217992-001 Apr 23, 2024 OTC No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Igi Labs Inc NALOXONE HYDROCHLORIDE naloxone hydrochloride INJECTABLE;INJECTION 072083-001 Apr 11, 1989 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hospira NALOXONE HYDROCHLORIDE naloxone hydrochloride INJECTABLE;INJECTION 070171-001 Sep 24, 1986 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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