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Last Updated: May 9, 2024

NALOXONE HYDROCHLORIDE Drug Patent Profile

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Which patents cover Naloxone Hydrochloride, and what generic alternatives are available?

Naloxone Hydrochloride is a drug marketed by Abraxis Pharm, Accord Hlthcare, Astrazeneca, Baxter Hlthcare Corp, Bpi Labs, Chartwell Rx, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hikma, 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, Padagis Israel, Teva Pharms Usa, Kaleo Inc, Lupin, and Sun Pharm Inds Ltd. and is included in sixty-seven NDAs. There are eighteen patents protecting this drug.

The generic ingredient in NALOXONE HYDROCHLORIDE 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.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Naloxone Hydrochloride

A generic version of NALOXONE HYDROCHLORIDE was approved as naloxone hydrochloride; pentazocine hydrochloride by WATSON LABS on January 21^st, 1997.

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Summary for NALOXONE HYDROCHLORIDE

US Patents:	0
Applicants:	28
NDAs:	67
Finished Product Suppliers / Packagers:	25
Raw Ingredient (Bulk) Api Vendors:	56
Clinical Trials:	350
Patent Applications:	1,792
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

Drug patent expirations by year for NALOXONE HYDROCHLORIDE

Recent Clinical Trials for NALOXONE HYDROCHLORIDE

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

Sponsor	Phase
DEKA S.r.l.	Phase 4
Johns Hopkins University	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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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
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
Igi Labs Inc	NALOXONE HYDROCHLORIDE	naloxone hydrochloride	INJECTABLE;INJECTION	072091-001	Apr 11, 1989		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Igi Labs Inc	NALOXONE HYDROCHLORIDE	naloxone hydrochloride	INJECTABLE;INJECTION	072082-001	Apr 11, 1989		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sun Pharm Inds Ltd	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	naloxone hydrochloride; pentazocine hydrochloride	TABLET;ORAL	075523-001	Mar 17, 2000	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Marsam Pharms Llc	NALOXONE HYDROCHLORIDE	naloxone hydrochloride	INJECTABLE;INJECTION	071811-001	Jul 19, 1988		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Solopak	NALOXONE HYDROCHLORIDE	naloxone hydrochloride	INJECTABLE;INJECTION	071672-001	Nov 17, 1987		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ 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

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