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Last Updated: April 4, 2020

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DAKLINZA Drug Profile


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When do Daklinza patents expire, and when can generic versions of Daklinza launch?

Daklinza is a drug marketed by Bristol-myers Squibb and is included in one NDA. There are five patents protecting this drug.

This drug has ninety-one patent family members in thirty-one countries.

The generic ingredient in DAKLINZA is daclatasvir dihydrochloride. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the daclatasvir dihydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Daklinza

Daklinza was eligible for patent challenges on July 24, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 13, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for DAKLINZA
Drug patent expirations by year for DAKLINZA
Drug Prices for DAKLINZA

See drug prices for DAKLINZA

Generic Entry Opportunity Date for DAKLINZA
Generic Entry Date for DAKLINZA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for DAKLINZA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Nanjing Sanhome Pharmaceutical, Co., Ltd.Phase 2/Phase 3
Johns Hopkins Bloomberg School of Public HealthPhase 2/Phase 3
National Institute on Drug Abuse (NIDA)Phase 2/Phase 3

See all DAKLINZA clinical trials

Synonyms for DAKLINZA
1009119-64-5
1009119-65-6
1214735-16-6
3503AH
50ZO25C11D
ABP000738
AC-28423
AC-28958
ACN-050889
AOB87340
AOB87747
AS-75298
AS-75330
BDBM50387084
BMS 790052
BMS 790052 (di HClsalt)
BMS 790052-05
BMS 790052; EBP 883
BMS-790052
BMS-790052 (dihydrochloride)
BMS-790052 dihydrochloride
BMS-790052-05
BMS790052
BMS790052 dihydrochloride
C40H50N8O6
CA10002
Carbamic acid, N,N'-[[1,1'-biphenyl]-4,4'-diylbis[1H-imidazole-5,2-diyl-(2S)-2,1-pyrrolidinediyl[(1S)-1-(1-methylethyl)-2-oxo-2,1-ethanediyl]]]bis-, C,C'-dimethyl ester
Carbamic acid, N,N'-[[1,1'-biphenyl]-4,4'-diylbis[1H-imidazole-5,2-diyl-(2S)-2,1-pyrrolidinediyl[(1S)-1-(1-methylethyl)-2-oxo-2,1-ethanediyl]]]bis-, C,C'-dimethyl ester, hydrochloride (1:2)
cc-39
CHEBI:82977
CHEBI:83800
CHEMBL2023898
CHEMBL2303621
CS-0270
CS-0588
D10065
D10105
Daclatasvir
Daclatasvir (BMS-790052)
Daclatasvir (dihydrochloride)
Daclatasvir (USAN)
Daclatasvir 2HCl
Daclatasvir BMS 790052
Daclatasvir Digydrochloride
Daclatasvir dihydrochloride
Daclatasvir dihydrochloride (BMS-790052)
Daclatasvir dihydrochloride (USAN)
daclatasvir hydrochloride
Daclatasvir hydrochloride (JAN)
daclatasvir-dihydrochloride
Daclatasvir, 1214735-16-6
Daklinza (TN)
DB09102
Dimethyl ((2S,2'S)-((2S,2'S)-2,2'-(5,5'-([1,1'-biphenyl]-4,4'-diyl)bis(1H-imidazole-5,2-diyl))bis(pyrrolidine-2,1-diyl))bis(3-methyl-1-oxobutane-2,1-diyl))dica
dimethyl ((2S,2'S)-((2S,2'S)-2,2'-(5,5'-([1,1'-biphenyl]-4,4'-diyl)bis(1H-imidazole-5,2-diyl))bis(pyrrolidine-2,1-diyl))bis(3-methyl-1-oxobutane-2,1-diyl))dicarbamate
dimethyl ((2S,2'S)-((2S,2'S)-2,2'-(5,5'-([1,1'-biphenyl]-4,4'-diyl)bis(1H-imidazole-5,2-diyl))bis(pyrrolidine-2,1-diyl))bis(3-methyl-1-oxobutane-2,1-diyl))dicarbamate dihydrochloride
Dimethyl (2S,2'S)-1,1'-((2S,2'S)-2,2'-(5,5'-(biphenyl-4,4'-diyl)bis(1H-imidazole-5,2-diyl))bis(pyrrolidine-2,1-diyl))bis(3-methyl-1-oxobutane-2,1-diyl)dicarbamate dihydrochloride
Dimethyl N,N'-(biphenyl-4,4'-diylbis(1H-imidazole-5,2-diyl-((2S)-pyrrolidine-2,1- diyl)((1S)-1-(1-methylethyl)-2-oxoethane-2,1-diyl)))dicarbamate dihydrochloride
Dimethyl N,N'-(biphenyl-4,4'-diylbis{1H-imidazole-5,2-diyl-((2S)-pyrrolidine-2,1- diyl)((1S)-1-(1-methylethyl)-2-oxoethane-2,1-diyl)})dicarbamate
EBP 883
EBP-883
EBP883
EX-A410
HY-10465
HY-10466
J-520204
KS-00000P35
KS-00000XPC
LI2427F9CI
methyl ((S)-1-((S)-2-(4-(4'-(2-((S)-1-((methoxycarbonyl)-L-valyl)pyrrolidin-2-yl)-1H-imidazol-4-yl)-[1,1'-biphenyl]-4-yl)-1H-imidazol-2-yl)pyrrolidin-1-yl)-3-methyl-1-oxobutan
methyl ((S)-1-((S)-2-(5-(4'-(2-((S)-1-((methoxycarbonyl)-L-valyl)pyrrolidin-2-yl)-1H-imidazol-5-yl)-[1,1'-biphenyl]-4-yl)-1H-imidazol-2-yl)pyrrolidin-1-yl)-3-methyl-1-oxobutan-2-yl)carbama
methyl ((S)-1-((S)-2-(5-(4'-(2-((S)-1-((methoxycarbonyl)-L-valyl)pyrrolidin-2-yl)-1H-imidazol-5-yl)-[1,1'-biphenyl]-4-yl)-1H-imidazol-2-yl)pyrrolidin-1-yl)-3-methyl-1-oxobutan-2-yl)carbamat
methyl [(2s)-1-{(2s)-2-[4-(4'-{2-[(2s)-1-{(2s)-2-[(methoxycarbonyl)amino]-3-methylbutanoyl}-2-pyrrolidinyl]-1h-imidazol-4-yl}-4-biphenylyl)-1h-imidazol-2-yl]-1-pyrrolidinyl}-3-methyl-1-oxo-2-butanyl]carbamate
methyl [(2S)-1-{(2S)-2-[4-(4'-{2-[(2S)-1-{(2S)-2-[(methoxycarbonyl)amino]-3-methylbutanoyl}pyrrolidin-2-yl]-1H-imidazol-4-yl}biphenyl-4-yl)-1H-imidazol-2-yl]pyrrolidin-1-yl}-3-methyl-1-oxobutan-2-yl]carbamate
methyl [(2S)-1-{(2S)-2-[4-(4'-{2-[(2S)-1-{(2S)-2-[(methoxycarbonyl)amino]-3-methylbutanoyl}pyrrolidin-2-yl]-1H-imidazol-4-yl}biphenyl-4-yl)-1H-imidazol-2-yl]pyrrolidin-1-yl}-3-methyl-1-oxobutan-2-yl]carbamate dihydrochlorid
Methyl [(2S)-1-{(2S)-2-[5-(4'-{2-[(2S)-1-{(2S)-2-[(methoxycarbonyl)amino]-3-methylbutanoyl}pyrrolidin-2-yl]-1H-imidazol-5-yl}biphenyl-4-yl)-1H-imidazol-2-yl]pyrrolidin-1-yl}-3-methyl-1-oxobutan-2-yl]carbamate
methyl N-[(1S)-1-[(2S)-2-[5-[4-[4-[2-[(2S)-1-[(2S)-2-(methoxycarbonylamino)-3-methyl-butanoyl]pyrrolidin-2-yl]-1H-imidazol-5-yl]phenyl]phenyl]-1H-imidazol-2-yl]pyrrolidine-1-carbonyl]-2-methyl-propyl]carbamate
methyl N-[(2S)-1-[(2S)-2-[5-(4'-{2-[(2S)-1-[(2S)-2-[(methoxycarbonyl)amino]-3-methylbutanoyl]pyrrolidin-2-yl]-1H-imidazol-5-yl}-[1,1'-biphenyl]-4-yl)-1H-imidazol-2-yl]pyrrolidin-1-yl]-3-methyl-1-oxobutan-2-yl]carbamate
methyl N-[(2S)-1-[(2S)-2-[5-(4'-{2-[(2S)-1-[(2S)-2-[(methoxycarbonyl)amino]-3-methylbutanoyl]pyrrolidin-2-yl]-1H-imidazol-5-yl}-[1,1'-biphenyl]-4-yl)-1H-imidazol-2-yl]pyrrolidin-1-yl]-3-methyl-1-oxobutan-2-yl]carbamate dih
methyl-N-[(2s)-1-[(2s)-2-[5-[4-[4-[2-[(2s)-1-[(2s)-2-(methoxycarbonylamino)-3-methylbutanoyl] pyrrolidin-2-yl]-1h-imidazol-5-yl]phenyl]phenyl]-1himidazol-2-yl]pyrrolidin-1-yl]3-methyl-1-oxobutan-2-yl]carbamate
MLS006011140
Q-4025
Q27157239
Q5207712
s1482
s5062
SB20303
SCHEMBL17870647
SCHEMBL17897804
SCHEMBL2756027
SMR004702917
SW219754-1
UNII-50ZO25C11D
UNII-LI2427F9CI
W-6070
X7549
ZINC68204830

US Patents and Regulatory Information for DAKLINZA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol-myers Squibb DAKLINZA daclatasvir dihydrochloride TABLET;ORAL 206843-001 Jul 24, 2015 DISCN Yes No   Start Trial   Start Trial Y Y   Start Trial
Bristol-myers Squibb DAKLINZA daclatasvir dihydrochloride TABLET;ORAL 206843-002 Jul 24, 2015 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Bristol-myers Squibb DAKLINZA daclatasvir dihydrochloride TABLET;ORAL 206843-002 Jul 24, 2015 DISCN Yes No   Start Trial   Start Trial Y 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

Supplementary Protection Certificates for DAKLINZA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2049522 PA2015006 Lithuania   Start Trial PRODUCT NAME: DACLATASVIRUM; REGISTRATION NO/DATE: EU/1/14/939/001 - EU/1/14/939/004 20140826
2049522 C02049522/01 Switzerland   Start Trial PRODUCT NAME: DACLATASVIRUM; REGISTRATION NO/DATE: SWISSMEDIC 65332 26.06.2015
2049522 C 2015 003 Romania   Start Trial PRODUCT NAME: DACLATASVIR SI SARURILE ACCEPTABILE FARMACEUTIC ALEACESTUIA, IN SPECIAL DACLATASVIR DICLORHIDRAT; NATIONAL AUTHORISATION NUMBER: EU/1/14/939/001, EU/1/14/939/002, EU/1/14/939/003, EU/1/14/939/004; DATE OF NATIONAL AUTHORISATION: 20140822; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/939/001, EU/1/14/939/002, EU/1/14/939/003, EU/1/14/939/004; DATE OF FIRST AUTHORISATION IN EEA: 20140822
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
McKesson
Boehringer Ingelheim
McKinsey
Dow
Harvard Business School

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 verification 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.