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Cipla
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Generated: May 25, 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. Seventeen 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
Akorn NALOXONE HYDROCHLORIDE naloxone hydrochloride INJECTABLE;INJECTION 208872-001 Mar 14, 2017 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Wyeth Ayerst NALOXONE naloxone hydrochloride INJECTABLE;INJECTION 070189-001 Sep 24, 1986 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Kaleo Inc EVZIO naloxone hydrochloride SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 205787-001 Apr 3, 2014 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Purdue Pharma Lp TARGINIQ naloxone hydrochloride; oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 205777-003 Jul 23, 2014 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
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
9,352,091 Devices, systems and methods for medicament delivery ➤ Try a Free Trial
8,105,281 Devices, systems and methods for medicament delivery ➤ Try a Free Trial
9,814,838 Medicament delivery device for administration of opioid antagonists including formulations for naloxone ➤ Try a Free Trial
9,084,849 Medicament delivery devices for administration of a medicament within a prefilled syringe ➤ Try a Free Trial
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 ➤ Try a Free 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Boehringer Ingelheim
Baxter
Julphar
UBS
Dow
US Department of Justice
Farmers Insurance
Covington

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.