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Last Updated: October 23, 2019

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DAKLINZA Drug Profile

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Which patents cover Daklinza, and what generic alternatives are available?

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 eighty-nine 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.

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
1009119-65-6
50ZO25C11D
AC-28423
AK546321
AKOS030632774
AOB87340
BMS 790052
BMS 790052 (di HClsalt)
BMS 790052-05
BMS-790052
BMS-790052 (dihydrochloride)
BMS-790052 dihydrochloride
BMS-790052-05
BMS790052 dihydrochloride
CHEBI:83800
CHEMBL2303621
CS-0270
D10105
Daclatasvir (dihydrochloride)
Daclatasvir dihydrochloride
Daclatasvir dihydrochloride (BMS-790052)
Daclatasvir dihydrochloride (USAN)
daclatasvir hydrochloride
Daclatasvir hydrochloride (JAN)
Daklinza (TN)
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 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
HY-10465
KS-00000P35
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
MolPort-042-665-812
SCHEMBL17870647
UNII-50ZO25C11D
W-6070

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
Bristol-myers Squibb DAKLINZA daclatasvir dihydrochloride TABLET;ORAL 206843-001 Jul 24, 2015 DISCN Yes No   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

Supplementary Protection Certificates for DAKLINZA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2049522 1590007-9 Sweden   Start Trial PRODUCT NAME: DACLATASVIR AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, ESPECIALLY DACLATASVIR DIHYDROCHLORIDE; REG. NO/DATE: EU/1/14/939 20140826
2049522 C20150003 00128 Estonia   Start Trial PRODUCT NAME: DAKLATASVIIR;REG NO/DATE: EU/1/14/939 26.08.2014
2049522 9/2015 Austria   Start Trial PRODUCT NAME: DECLATASVIR; REGISTRATION NO/DATE: EU/1/14/939 (MITTEILUNG) 20140826
2049522 300713 Netherlands   Start Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF OWNER(S) NAME
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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McKinsey
Express Scripts
McKesson
Merck
Harvard Business School

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