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 eleven branded drugs marketed by Hikma, Wyeth Ayerst, Abraxis Pharm, Akorn, Anda Repository, Astrazeneca, Baxter Hlthcare Corp, Dr Reddys, Eugia Pharma, Hospira, Igi Labs Inc, Intl Medication, Marsam Pharms Llc, Mylan Institutional, Mylan Labs Ltd, Par Sterile Products, Smith And Nephew, Solopak, Somerset Theraps Llc, Watson Labs, Adapt, Bristol Myers Squibb, Kaleo Inc, Adamis Pharms Corp, Padagis Israel, Teva Pharms Usa, Emergent, Purdue Pharma Lp, Lupin, Sun Pharm Inds Ltd, and Sanofi Aventis Us, and is included in eighty NDAs. There are sixty-one 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 ninety-four patent family members in twenty countries.

There are eight drug master file entries for naloxone hydrochloride. Twenty-six suppliers are listed for this compound.

Summary for naloxone hydrochloride

International Patents:	194
US Patents:	61
Tradenames:	11
Applicants:	31
NDAs:	80
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	26
Raw Ingredient (Bulk) Api Vendors:	52
Clinical Trials:	344
Patent Applications:	2,879
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
Icahn School of Medicine at Mount Sinai	Phase 3
Royal Victoria Hospital, Canada	Phase 4
Ensysce Biosciences	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

Paragraph IV (Patent) Challenges for NALOXONE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
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
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-003	Jul 23, 2014		DISCN	Yes	No	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Somerset Theraps Llc	NALOXONE HYDROCHLORIDE	naloxone hydrochloride	INJECTABLE;INJECTION	207634-001	Jul 26, 2017	AP	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Kaleo Inc	EVZIO (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	209862-001	Oct 19, 2016		DISCN	Yes	No	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Kaleo Inc	EVZIO (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	209862-001	Oct 19, 2016		DISCN	Yes	No	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Kaleo Inc	EVZIO (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	209862-001	Oct 19, 2016		DISCN	Yes	No	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
>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
United Kingdom	201315737		See Plans and Pricing
Japan	5680852		See Plans and Pricing
Canada	2743303	APPAREIL ET PROCEDES POUR L'AUTO-ADMINISTRATION DE VACCINS ET D'AUTRES MEDICAMENTS (APPARATUS AND METHODS FOR SELF-ADMINISTRATION OF VACCINES AND OTHER MEDICAMENTS)	See Plans and Pricing
Canada	2976873	DISPOSITIFS, SYSTEMES ET PROCEDES POUR ADMINISTRER UN MEDICAMENT (DEVICES, SYSTEMS, AND METHODS FOR MEDICAMENT DELIVERY)	See Plans and Pricing
United Kingdom	2471981	Medicament delivery device having an electronic circuit system	See Plans and Pricing
>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	See Plans and Pricing	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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