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 eight branded drugs marketed by West-ward Pharms Int, Wyeth Ayerst, Abraxis Pharm, Akorn, Astrazeneca, Aurobindo Pharma Ltd, Dr Reddys, Eurohlth Intl Sarl, Hospira, Igi Labs Inc, Intl Medication, Marsam Pharms Llc, Mylan Institutional, Par Sterile Products, Smith And Nephew, Solopak, Somerset Theraps Llc, Virtus Pharms, Watson Labs, Adapt, Bristol Myers Squibb, Kaleo Inc, Teva Pharms Usa, Emergent, Purdue Pharma Lp, Lupin, Sun Pharm Inds Ltd, and Sanofi Aventis Us, and is included in seventy-one NDAs. There are fifty-five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Naloxone hydrochloride has one hundred and seventy patent family members in eighteen countries.

There are twelve drug master file entries for naloxone hydrochloride. Eighteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for naloxone hydrochloride

International Patents:	170
US Patents:	55
Tradenames:	8
Applicants:	28
NDAs:	71
Drug Master File Entries:	12
Suppliers / Packagers:	18
Bulk Api Vendors:	46
Clinical Trials:	292
Patent Applications:	1,458
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
Trustees of Dartmouth College	Early Phase 1
Columbia University	Phase 1
Go Medical Industries Pty Ltd	Phase 1

See all naloxone hydrochloride clinical trials

Generic filers with tentative approvals for NALOXONE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
Start Trial	Start Trial	4MG/SPRAY	SPRAY, METERED;NASAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for naloxone hydrochloride

Drug Class	Opioid Antagonist
Mechanism of Action	Opioid Antagonists

Medical Subject Heading (MeSH) Categories for naloxone hydrochloride

Narcotic Antagonists

Paragraph IV (Patent) Challenges for NALOXONE HYDROCHLORIDE

Tradename	Dosage	Ingredient	NDA	Submissiondate
NARCAN	SPRAY, METERED;NASAL	naloxone hydrochloride	208411	2017-12-28
NARCAN	SPRAY, METERED;NASAL	naloxone hydrochloride	208411	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
Igi Labs Inc	NALOXONE HYDROCHLORIDE	naloxone hydrochloride	INJECTABLE;INJECTION	072090-001	Apr 11, 1989		DISCN	No	No	Start Trial	Start Trial				Start Trial
Igi Labs Inc	NALOXONE HYDROCHLORIDE	naloxone hydrochloride	INJECTABLE;INJECTION	072085-001	Apr 11, 1989		DISCN	No	No	Start Trial	Start Trial				Start Trial
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-002	Jul 23, 2014		DISCN	Yes	No	Start Trial	Start Trial	Y			Start Trial
Hospira	NALOXONE HYDROCHLORIDE	naloxone hydrochloride	INJECTABLE;INJECTION	070257-001	Jan 7, 1987	AP	RX	No	Yes	Start Trial	Start Trial				Start 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	Estimated Expiration
Singapore	11201607281P	Start Trial
China	106163499	Start Trial
United Kingdom	2471981	Start Trial
Canada	2950687	Start Trial
>Country	>Patent Number	>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	Start 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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