Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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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.

Recent Clinical Trials for naloxone hydrochloride

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SponsorPhase
University Hospital, AkershusN/A
University of California, San DiegoEarly Phase 1
Brown UniversityPhase 1

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Recent Litigation for naloxone hydrochloride

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District Court Litigation
Case NameDate
kaleo, Inc. v. Adamis Pharmaceuticals Corp.2019-05-16
ADAPT PHARMA OPERATIONS LIMITED v. PERRIGO UK FINCO LIMITED PARTNERSHIP2018-12-07
ADAPT PHARMA OPERATIONS LIMITED v. TEVA PHARMACEUTICALS USA, INC.2018-05-30

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PTAB Litigation
PetitionerDate
Nalox-1 Pharmaceuticals, LLC2019-02-19

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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
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

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

Supplementary Protection Certificates for naloxone hydrochloride

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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Harvard Business School
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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.