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Last Updated: November 20, 2019

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NARCAN Drug Profile

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When do Narcan patents expire, and what generic alternatives are available?

Narcan is a drug marketed by Adapt and Bristol Myers Squibb and is included in five NDAs. There are eight patents protecting this drug and two Paragraph IV challenges.

This drug has twenty-one patent family members in fourteen countries.

The generic ingredient in NARCAN is naloxone hydrochloride. There are twelve drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride profile page.

Drug patent expirations by year for NARCAN
Drug Prices for NARCAN

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Recent Clinical Trials for NARCAN

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SponsorPhase
Sameh Hanna, MDEarly Phase 1
National Institute on Drug Abuse (NIDA)N/A
University of CincinnatiN/A

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Recent Litigation for NARCAN

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District Court Litigation
Case NameDate
ADAPT PHARMA OPERATIONS LIMITED v. PERRIGO UK FINCO LIMITED PARTNERSHIP2018-12-07
ADAPT PHARMA OPERATIONS LIMITED v. TEVA PHARMACEUTICALS USA, INC.2018-05-30
ADAPT PHARMA OPERATIONS LIMITED v. TEVA PHARMACEUTICALS USA, INC.2017-07-12

See all NARCAN litigation

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

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Pharmacology for NARCAN
Drug ClassOpioid Antagonist
Mechanism of ActionOpioid Antagonists
Synonyms for NARCAN
(-)-N-allyl-14-hydroxynordihydroxymorphinan-6-one
(-)-Naloxone
(1S,5R,13R,17S)-10,17-dihydroxy-4-(prop-2-en-1-yl)-12-oxa-4-azapentacyclo[9.6.1.0^{1,13}.0^{5,17}.0^{7,18}]octadeca-7(18),8,10-trien-14-one
(1S,5R,13R,17S)-10,17-dihydroxy-4-(prop-2-en-1-yl)-12-oxa-4-azapentacyclo[9.6.1.0;{1,13}.0;{5,17}.0;{7,18}]octadeca-7(18),8,10-trien-14-one
(4R,4aS,7aR,12bS)-3-allyl-4a,9-dihydroxy-2,4,5,6,7a,13-hexahydro-1H-4,12-methanobenzofuro[3,2-e]isoquinoline-7-one;hydrochloride
(4R,4aS,7aR,12bS)-4a,9-bis(oxidanyl)-3-prop-2-enyl-2,4,5,6,7a,13-hexahydro-1H-4,12-methanobenzofuro[3,2-e]isoquinoline-7-one;hydrochloride
(4R,4aS,7aR,12bS)-4a,9-dihydroxy-3-prop-2-enyl-2,4,5,6,7a,13-hexahydro-1H-4,12-methanobenzofuro[3,2-e]isoquinoline-7-one;hydrochloride
(5alpha)-3,14-dihydroxy-17-prop-2-en-1-yl-4,5-epoxymorphinan-6-one
(5alpha)-4,5-Epoxy-3,14-dihydroxy-17-(2-propenyl)morphinan-6-one
(naloxone) 4-allyl-10,17-dihydroxy-(1S,5R,13R,17S)-12-oxa-4-azapentacyclo[9.6.1.01,13.05,17.07,18]octadeca-7(18),8,10-trien-14-one
(naloxone)4-allyl-10,17-dihydroxy-(1S,5R,13R,17S)-12-oxa-4-azapentacyclo[9.6.1.01,13.05,17.07,18]octadeca-7(18),8,10-trien-14-one
(naloxone)4-allyl-10,17-dihydroxy-12-oxa-4-azapentacyclo[9.6.1.01,13.05,17.07,18]octadeca-7(18),8,10-trien-14-one
[17-(2,3-3H-2-propenyl)]-4, 5a -epoxy-3,14-dihydroxymorphinan-6-one
[3H]naloxone
[N-allyl-2,3-3H]naloxone
1-N-Allyl-14-hydroxynordihydromorphinone
1-N-Allyl-7,8-dihydro-14-hydroxynormorphinone
12-Allyl-7,7a,8,9-tetrahydro-3,7a-dihydroxy-4aH-8,9c-iminoethanophenanthro(4,5-bcd)furanone
12-Allyl-7,7a,8,9-tetrahydro-3,7a-dihydroxy-4aH-8,9c-iminoethanophenanthro[4,5-bcd]furan-5(6H)-one
17-allyl-3,14-dihydroxy-4,5alpha-epoxymorphinan-6-one
17-Allyl-4,5-alpha-epoxy-3,14-dihydroxymorphinan-6-one
17-Allyl-4,5alpha-epoxy-3,14-dihydroxymorphinan-6-one
3,14-dihydroxy-17-(prop-2-en-1-yl)-4,5alpha-epoxymorphinan-6-one
357-08-4 (hydrochloride)
36B82AMQ7N
4-allyl-10,17-dihydroxy-(1S,5R,13R,17S)-12-oxa-4-azapentacyclo[9.6.1.01,13.05,17.07,18]octadeca-7(18),8,10-trien-14-one
4-allyl-10,17-dihydroxy-(1S,5R,13R,17S)-12-oxa-4-azapentacyclo[9.6.1.01,13.05,17.07,18]octadeca-7(18),8,10-trien-14-one (naloxone)
4-allyl-10,17-dihydroxy-(1S,5R,13R,17S)-12-oxa-4-azapentacyclo[9.6.1.01,13.05,17.07,18]octadeca-7(18),8,10-trien-14-one( Naloxone)
4-allyl-10,17-dihydroxy-(1S,5R,13R,17S)-12-oxa-4-azapentacyclo[9.6.1.01,13.05,17.07,18]octadeca-7(18),8,10-trien-14-one(Naxolone)
4-allyl-10,17-dihydroxy-12-oxa-4-azapentacyclo[9.6.1.01,13.05,17.07,18]octadeca-7(18),8,10-trien-14-one
4-allyl-10,17-dihydroxy-12-oxa-4-azapentacyclo[9.6.1.01,13.05,17.07,18]octadeca-7(18),8,10-trien-14-one(naloxone)C2H2O4
465-65-6
465N656
4aH-8,5-bcd]furan-5(6H)-one, N-allyl-7,7a,8,9-tetrahydro-3,7a-dihydroxy-
AJ-20933
AKOS016009988
AN-45114
API0003490
BDBM50000788
BDBM54795
BIDD:GT0110
BPBio1_000136
BRD-K67511046-001-02-3
BRD-K67511046-003-03-7
BRN 1089071
BSPBio_000122
C07252
CAS-465-65-6
CHEBI:7459
CHEMBL80
cid_5464092
D08249
DB01183
DBL Naloxone (TN)
DSSTox_CID_3349
DSSTox_GSID_23349
DSSTox_RID_76986
DTXSID8023349
EINECS 207-365-7
EN 1530 base
GTPL1638
GTPL1676
HMS2090F20
HSDB 3279
KB-297992
l-N-Allyl-14-hydroxynordihydromorphinone
l-N-Allyl-7,8-dihydro-14-hydroxynormorphinone
l-Naloxone
LS-187184
LS-92141
MCULE-1335589007
MLS000069540
MLS000736771
Morphinan-6-one, 17-allyl-4,5alpha-epoxy-3,14-dihydroxy-
Morphinan-6-one, 17-allyl-4,5alpha-epoxy-3,14-dihydroxy- (8CI)
Morphinan-6-one, 4,5-alpha-epoxy-3,14-dihydroxy-17-(2-propenyl)-
Morphinan-6-one, 4,5-epoxy-3,14-dihydroxy-17-(2-propenyl)-, (5alpha)-
Morphinan-6-one, 4,5-epoxy-3,14-dihydroxy-17-(2-propenyl)-, (5alpha)- (9CI)
Morphinan-6-one, 4,5alpha-epoxy-3,14-dihydroxy-17-(2-propenyl)-
Morphinan-6-one,4,5-epoxy-3,14-dihydroxy-17-(2-propenyl)-,(5|A)-
Morphinan-6-one,5-epoxy-3,14-dihydroxy-17-(2-propenyl)-, (5.alpha.)-
Morphinan-6-one,5.alpha.-epoxy-3,14-dihydroxy-
Morphinan-6-one,5.alpha.-epoxy-3,14-dihydroxy-17-(2-propenyl)-
N-Allyl-4,5alpha-epoxy-3,14-dihydroxy-6-morphinanon
N-Allyl-noroxymorphone
n-Allylnoroxymorphone
Nalone
Nalossone
Nalossone [DCIT]
Naloxona
Naloxona [INN-Spanish]
naloxone
Naloxone (INN)
Naloxone [INN:BAN]
Naloxone Nasal Spray
Naloxone solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material
Naloxonum
Naloxonum [INN-Latin]
Narcanti
Narcon
NCGC00024674-02
NCGC00024674-03
NCGC00162267-02
NCGC00274058-01
Normorphinone, N-allyl-7,8-dihydro-14-hydroxy-, (-)-
Normorphinone, N-allyl-dihydro-14-hydroxy-
NSC 70413
NSC-70413
NSC70413
Nyxoid
O940
PDSP2_001520
Prestwick0_000111
Prestwick1_000111
Prestwick2_000111
Prestwick3_000111
SCHEMBL34284
SMP1_000205
SMR000058766
SPBio_002061
Tox21_112006
Tox21_112006_1
UNII-36B82AMQ7N
UZHSEJADLWPNLE-GRGSLBFTSA-N
ZINC389747
Paragraph IV (Patent) Challenges for NARCAN
Tradename Dosage Ingredient NDA Submissiondate
NARCAN SPRAY, METERED;NASAL naloxone hydrochloride 208411 2016-07-15

US Patents and Regulatory Information for NARCAN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Adapt NARCAN naloxone hydrochloride INJECTABLE;INJECTION 016636-002 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   Start Trial
Adapt NARCAN naloxone hydrochloride SPRAY, METERED;NASAL 208411-002 Jan 24, 2017 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Bristol Myers Squibb NARCAN naloxone hydrochloride INJECTABLE;INJECTION 071083-001 Jul 28, 1988 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for NARCAN

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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