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Generated: December 17, 2018

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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 seventy-eight patent family members in thirty-one countries.

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

Summary for DAKLINZA
Drug patent expirations by year 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.

Synonyms for DAKLINZA
1009119-64-5
1009119-65-6
1214735-16-6
3503AH
50ZO25C11D
ABP000738
AC-28423
AKOS030524262
AKOS030632774
AOB87340
AOB87747
BC638780
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
cc-39
CHEBI:82977
CHEBI:83800
CHEMBL2023898
CHEMBL2303621
CS-0270
CS-0588
D09SGV
D10065
D10105
daclatasivr
Daclatasvir
Daclatasvir (BMS-790052)
Daclatasvir (dihydrochloride)
Daclatasvir (USAN)
Daclatasvir 2HCl
Daclatasvir BMS 790052
Daclatasvir dihydrochloride
Daclatasvir dihydrochloride (BMS-790052)
Daclatasvir dihydrochloride (USAN)
daclatasvir HCl
daclatasvir hydrochloride
Daclatasvir hydrochloride (JAN)
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))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'-(4,4'-(biphenyl-4,4'-diyl)bis(1H-imidazole-4,2-diyl))bis(pyrrolidine-2,1-diyl))bis(3-methyl-1-oxobutane-2,1-diyl)dicarbamate
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
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 dihydrochloride
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
MFCD17129086
MFCD25541736
MLS006011140
MolPort-016-633-220
MolPort-027-720-848
MolPort-042-665-812
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]]]biscarbamic acid C,C'-dimethyl ester
Q-4025
RL00957
s1482
SCHEMBL17870647
SCHEMBL17897804
SCHEMBL2756027
SMR004702917
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 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Bristol-myers Squibb DAKLINZA daclatasvir dihydrochloride TABLET;ORAL 206843-002 Jul 24, 2015 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Bristol-myers Squibb DAKLINZA daclatasvir dihydrochloride TABLET;ORAL 206843-001 Jul 24, 2015 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Bristol-myers Squibb DAKLINZA daclatasvir dihydrochloride TABLET;ORAL 206843-002 Jul 24, 2015 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Bristol-myers Squibb DAKLINZA daclatasvir dihydrochloride TABLET;ORAL 206843-003 Apr 13, 2016 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Bristol-myers Squibb DAKLINZA daclatasvir dihydrochloride TABLET;ORAL 206843-002 Jul 24, 2015 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y 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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International Patents for DAKLINZA

Country Document Number Estimated Expiration
New Zealand 574805 ➤ Try a Free Trial
Slovenia 2049522 ➤ Try a Free Trial
Taiwan 200911790 ➤ Try a Free Trial
World Intellectual Property Organization (WIPO) 2009020828 ➤ Try a Free Trial
South Korea 101508022 ➤ Try a Free Trial
New Zealand 583148 ➤ Try a Free Trial
Country Document Number Estimated Expiration

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Supplementary Protection Certificates for DAKLINZA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1 50001-2015 Slovakia ➤ Try a Free Trial PRODUCT NAME: DAKLATASVIR DIHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/939 - EU/1/14/939/004 20140826
2015 Austria ➤ Try a Free Trial PRODUCT NAME: DECLATASVIR; REGISTRATION NO/DATE: EU/1/14/939 (MITTEILUNG) 20140826
C0007 France ➤ Try a Free Trial PRODUCT NAME: DACLATASVIR ET DES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI,EN PARTICULIER LE SEL DE DICHLORHYDRATE DE DACLATASVIR; REGISTRATION NO/DATE: EU/1/14/939/001 20140826
90007-9 Sweden ➤ Try a Free Trial PRODUCT NAME: DACLATASVIR AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, ESPECIALLY DACLATASVIR DIHYDROCHLORIDE; REG. NO/DATE: EU/1/14/939 20140826
635 Luxembourg ➤ Try a Free Trial PRODUCT NAME: DACLATASVIR ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES , EN PARTICULIER DICHLORHYDRATE DE DACLATASVIR. FIRST REGISTRATION: 20140826
2015 00003 Denmark ➤ Try a Free Trial PRODUCT NAME: DACLATASVIR OG FARMACEUTISK ACCEPTABLE SALTE DERAF, SAERLIGT DACLATASVIR-DIHYDROCHLORID; REG. NO/DATE: EU/1/14/939 20140822
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Mallinckrodt
Harvard Business School
McKinsey
US Department of Justice
QuintilesIMS
Farmers Insurance
Baxter
Federal Trade Commission

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