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Last Updated: November 14, 2019

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Naloxone hydrochloride - Generic Drug Details

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What are the generic sources for naloxone hydrochloride and what is the scope of freedom to operate?

Naloxone hydrochloride is the generic ingredient in eight branded drugs marketed by West-ward Pharms Int, Wyeth Ayerst, Abraxis Pharm, Akorn, Astrazeneca, Eurohlth Intl Sarl, Hospira, Igi Labs Inc, Intl Medication, Marsam Pharms Llc, Mylan Institutional, Smith And Nephew, Solopak, Somerset Theraps Llc, Virtus Pharms, Watson Labs, Adapt, Bristol Myers Squibb, Kaleo Inc, Teva Pharms Usa, Purdue Pharma Lp, Lupin, Sun Pharm Inds Ltd, and Sanofi Aventis Us, and is included in sixty-seven NDAs. There are fifty-four 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 sixty-three patent family members in eighteen countries.

There are twelve drug master file entries for naloxone hydrochloride. Twenty suppliers are listed for this compound.

Summary for naloxone hydrochloride

International Patents:	163
US Patents:	54
Tradenames:	8
Applicants:	24
NDAs:	67
Drug Master File Entries:	12
Suppliers / Packagers:	20
Bulk Api Vendors:	43
Clinical Trials:	264
Patent Applications:	1,406
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for naloxone hydrochloride
DailyMed Link:	naloxone hydrochloride at DailyMed

Recent Clinical Trials for naloxone hydrochloride

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Sponsor	Phase
University Hospital, Akershus	N/A
University of California, San Diego	Early Phase 1
Brown University	Phase 1

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Recent Litigation for naloxone hydrochloride

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District Court Litigation

Case Name	Date
kaleo, Inc. v. Adamis Pharmaceuticals Corp.	2019-05-16
ADAPT PHARMA OPERATIONS LIMITED v. PERRIGO UK FINCO LIMITED PARTNERSHIP	2018-12-07
ADAPT PHARMA OPERATIONS LIMITED v. TEVA PHARMACEUTICALS USA, INC.	2018-05-30

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PTAB Litigation

Petitioner	Date
Nalox-1 Pharmaceuticals, LLC	2019-02-19

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Pharmacology for naloxone hydrochloride

Drug Class	Opioid Antagonist
Mechanism of Action	Opioid Antagonists

Medical Subject Heading (MeSH) Categories for naloxone hydrochloride

Narcotic Antagonists

Synonyms for naloxone hydrochloride

(-)-N-Allyl-14-hydroxynordihydromorphinone hydrochloride
(17R)-17-allyl-3,14-dihydroxy-6-oxo-4,5alpha-epoxymorphinan-17-ium chloride
(4R,4AS,7aR,12bS)-3-allyl-4a,9-dihydroxy-2,3,4,4a,5,6-hexahydro-1H-4,12-methanobenzofuro[3,2-e]isoquinolin-7(7aH)-one hydrochloride
(5?)-4,5-Epoxy-3,14-dihydro-17-(2-propenyl)morphinan-6-one hydrochloride
(5\|A)-4,5-Epoxy-3,14-dihydroxy-17-(2-propenyl)morphinan-6-one Hydrochloride
(5a)-17-allyl-4,5-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride
(5alpha,17R)-17-allyl-3,14-dihydroxy-6-oxo-4,5-epoxymorphinan-17-ium chloride
(5alpha)-17-allyl-3,14-dihydroxy-4,5-epoxymorphinan-6-one hydrochloride
(5alpha)-17-Allyl-4,5-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride
(5alpha)-4,5-Epoxy-3,14-dihydro-17-(2-propenyl)morphinan-6-one hydrochloride
17-allyl-3,14-dihydroxy-4,5alpha-epoxymorphinan-6-one hydrochloride
17-Allyl-4,5-alpha-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride
17-Allyl-4,5\|A-epoxy-3,14-dihydroxymorphinan-6-one Hydrochloride
17-Allyl-4,5alpha-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride
357-08-4
357N084
465-65-6 (Parent)
ACN-032222
ACT02626
AKOS024418753
AN-44507
API0006888
CCG-220111
CHEBI:31892
CHEMBL1718
CS-1335
D01340
EINECS 206-611-0
EN 15304
EN-15304
Evzio
F850569PQR
FT-0082479
H859
HMS1568G04
HY-17417
KS-5379
l-N-Allyl-14-hydroxynordihydromorphinone hydrochloride
MCULE-7328605584
MFCD00069322
MLS000069540
Morphinan-6-one, 17-allyl-4,5-alpha-epoxy-3,14-dihydroxy-, hydrochloride
Morphinan-6-one, 4,5-epoxy-3,14-dihydroxy-17-(2-propenyl)-, hydrochloride, (5alpha)-
Nafoxone Hydrochloride
nal-oxon hydrochloride
Nalonee
Naloxone (hydrochloride)
Naloxone HCl
Naloxone hydrochloride (JP17/USP)
Naloxone hydrochloride [USAN:USP:JAN]
Naloxonehydrochloride
Narcan
Narcan (TN)
Narcanti
NC00587
NIH 7890
NIH 7890; Narcan
Normorphinone, N-allyl-7,8-dihydro-14-hydroxy-, hydrochloride, (-)-
Prestwick_879
RGPDIGOSVORSAK-STHHAXOLSA-N
s3066
SC-81820
SCHEMBL41390
SMR000058766
SR-01000597918
SR-01000597918-1
SR-01000737374
SR-01000737374-3
SW197001-3
UNII-F850569PQR
W-106655
W-5064

Paragraph IV (Patent) Challenges for NALOXONE HYDROCHLORIDE

Tradename	Dosage	Ingredient	NDA	Submissiondate
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
Kaleo Inc	EVZIO	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	205787-001	Apr 3, 2014		DISCN	Yes	No	Start Trial	Start Trial	Y			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
Igi Labs Inc	NALOXONE HYDROCHLORIDE	naloxone hydrochloride	INJECTABLE;INJECTION	072091-001	Apr 11, 1989		DISCN	No	No	Start Trial	Start Trial				Start Trial
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-001	Jul 23, 2014		DISCN	Yes	No	Start Trial	Start Trial	Y			Start Trial
Kaleo Inc	EVZIO	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	205787-001	Apr 3, 2014		DISCN	Yes	No	Start Trial	Start Trial				Start Trial
Hospira	NALOXONE HYDROCHLORIDE	naloxone hydrochloride	INJECTABLE;INJECTION	070255-001	Jan 7, 1987		DISCN	No	No	Start Trial	Start Trial				Start Trial
Adapt	NARCAN	naloxone hydrochloride	SPRAY, METERED;NASAL	208411-001	Nov 18, 2015		RX	Yes	Yes	Start Trial	Start Trial	Y			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
United Kingdom	201108993	Start Trial
Mexico	340391	Start Trial
World Intellectual Property Organization (WIPO)	2015136373	Start Trial
Denmark	2285360	Start Trial
World Intellectual Property Organization (WIPO)	2008064092	Start Trial
World Intellectual Property Organization (WIPO)	2012103303	Start Trial
United Kingdom	2451769	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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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