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Generated: October 19, 2018

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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 naloxone hydrochloride patent protection?

Naloxone hydrochloride is the generic ingredient in seven 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, Watson Labs, Adapt, Bristol Myers Squibb, Kaleo Inc, Purdue Pharma Lp, Gavis Pharms, Sun Pharm Inds Ltd, and Sanofi Aventis Us, and is included in sixty-five 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.

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

Pharmacology for naloxone hydrochloride
Drug ClassOpioid Antagonist
Mechanism of ActionOpioid Antagonists
Medical Subject Heading (MeSH) Categories for naloxone hydrochloride
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
AK393255
AKOS024418753
Ambap357-08-4
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)
NC00587
NIH 7890
Normorphinone, N-allyl-7,8-dihydro-14-hydroxy-, hydrochloride, (-)-
Prestwick_879
RGPDIGOSVORSAK-STHHAXOLSA-N
s3066
SC-81820
SCHEMBL41390
SMR000058766
SR-01000737374
SR-01000737374-3
UNII-F850569PQR
W-106655
W-5064

US Patents and Regulatory Information for naloxone hydrochloride

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 ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Purdue Pharma Lp TARGINIQ naloxone hydrochloride; oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 205777-003 Jul 23, 2014 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Hospira NALOXONE HYDROCHLORIDE naloxone hydrochloride INJECTABLE;INJECTION 070252-001 Jan 16, 1987 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Igi Labs Inc NALOXONE HYDROCHLORIDE naloxone hydrochloride INJECTABLE;INJECTION 072086-001 Apr 11, 1989 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
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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Supplementary Protection Certificates for naloxone hydrochloride

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
292 Luxembourg ➤ Sign Up 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Deloitte
UBS
Queensland Health
Fish and Richardson
QuintilesIMS
Baxter
Daiichi Sankyo
Accenture

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