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Last Updated: April 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, 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, 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-six 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 suppliers are listed for this compound.

Summary for naloxone hydrochloride

International Patents:	245
US Patents:	48
Tradenames:	13
Applicants:	36
NDAs:	86
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	30
Raw Ingredient (Bulk) Api Vendors:	56
Clinical Trials:	350
Patent Applications:	2,622
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for naloxone hydrochloride
What excipients (inactive ingredients) are in naloxone hydrochloride?	naloxone hydrochloride excipients list
DailyMed Link:	naloxone hydrochloride at DailyMed

Recent Clinical Trials for naloxone hydrochloride

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

Sponsor	Phase
Johns Hopkins University	Phase 4
DEKA S.r.l.	Phase 4
Nirsum Labs	Phase 1

See all naloxone hydrochloride clinical trials

Pharmacology for naloxone hydrochloride

Drug Class	Opioid Antagonist
Mechanism of Action	Opioid Antagonists

Medical Subject Heading (MeSH) Categories for naloxone hydrochloride

Narcotic Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for naloxone hydrochloride

A06AH	Peripheral opioid receptor antagonists
A06A	DRUGS FOR CONSTIPATION
A06	DRUGS FOR CONSTIPATION
A	Alimentary tract and metabolism

V03AB	Antidotes
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma	NALOXONE	naloxone hydrochloride	INJECTABLE;INJECTION	070496-001	Sep 24, 1986		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Wyeth Ayerst	NALOXONE	naloxone hydrochloride	INJECTABLE;INJECTION	070189-001	Sep 24, 1986		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Intl Medication	NALOXONE HYDROCHLORIDE	naloxone hydrochloride	INJECTABLE;INJECTION	072076-001	Mar 24, 1988	AP	RX	No	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Kaleo Inc	EVZIO (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	209862-001	Oct 19, 2016		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Baxter Hlthcare Corp	NALOXONE HYDROCHLORIDE	naloxone hydrochloride	INJECTABLE;INJECTION	214785-001	Jan 29, 2021	AP	RX	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
Kaleo Inc	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	215457-001	Feb 28, 2022		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial	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

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Country	Patent Number	Title	Estimated Expiration
Australia	2012211307	Medicament delivery devices for administration of a medicament within a prefilled syringe	⤷ Try a Trial
Russian Federation	2013155479	ИНТРАНАЗАЛЬНЫЕ ФАРМАЦЕВТИЧЕСКИЕ ДОЗИРОВАННЫЕ ФОРМЫ, СОДЕРЖАЩИЕ НАЛОКСОН	⤷ Try a Trial
China	103764119	Intranasal pharmaceutical dosage forms comprising naloxone	⤷ Try a Trial
Australia	2012211320	Devices and methods for delivering medicaments from a multi-chamber container	⤷ Try a Trial
Japan	2016128453	ナロキソンを含む鼻腔内医薬剤形 (INTRANASAL PHARMACEUTICAL DOSAGE FORMS COMPRISING NALOXONE)	⤷ Try a Trial
Australia	2004325202	Devices, systems, and methods for medicament delivery	⤷ Try a Trial
Mexico	2007009152	DISPOSITIVOS, SISTEMA Y METODOS PARA EL SUMINISTRO DE MEDICAMENTOS. (DEVICES, SYSTEMS, AND METHODS FOR MEDICAMENT DELIVERY.)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for naloxone hydrochloride

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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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