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Chinese Patent Office
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Generated: August 20, 2018

DrugPatentWatch Database Preview

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 freedom to operate?

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-three 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 fifty patent family members in seventeen countries.

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

Summary for naloxone hydrochloride
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
Kaleo Inc EVZIO naloxone hydrochloride SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 205787-001 Apr 3, 2014 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Kaleo Inc EVZIO naloxone hydrochloride SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 209862-001 Oct 19, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Kaleo Inc EVZIO naloxone hydrochloride SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 209862-001 Oct 19, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Kaleo Inc EVZIO naloxone hydrochloride SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 209862-001 Oct 19, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Smith And Nephew NALOXONE HYDROCHLORIDE naloxone hydrochloride INJECTABLE;INJECTION 071671-001 Nov 17, 1987 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Igi Labs Inc NALOXONE HYDROCHLORIDE naloxone hydrochloride INJECTABLE;INJECTION 072083-001 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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Non-Orange Book US Patents for naloxone hydrochloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,084,849 Medicament delivery devices for administration of a medicament within a prefilled syringe ➤ Sign Up
9,173,999 Devices and methods for delivering medicaments from a multi-chamber container ➤ Sign Up
9,814,838 Medicament delivery device for administration of opioid antagonists including formulations for naloxone ➤ Sign Up
7,416,540 Devices systems and methods for medicament delivery ➤ Sign Up
7,648,482 Devices, systems, and methods for medicament delivery ➤ Sign Up
7,648,483 Devices, systems and methods for medicament delivery ➤ Sign Up
Patent No. Title Estimated Patent 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:

Moodys
Fish and Richardson
AstraZeneca
Federal Trade Commission
Citi
US Department of Justice
Cantor Fitzgerald
Cipla
Boehringer Ingelheim

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