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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

International Patents:	91
US Patents:	5
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	90
Clinical Trials:	11
Patent Applications:	103
Drug Prices:	Drug price information for DAKLINZA
DailyMed Link:	DAKLINZA at DailyMed

Drug patent expirations by year for DAKLINZA

Generic Entry Opportunity Date for DAKLINZA

Generic Entry Date for DAKLINZA^: Start Trial* Constraining patent/regulatory exclusivity: Start Trial NDA: 206843 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

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

See all DAKLINZA clinical trials

Pharmacology for DAKLINZA

Drug Class	Hepatitis C Virus NS5A Inhibitor
Mechanism of Action	P-Glycoprotein Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors Breast Cancer Resistance Protein Inhibitors

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

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Glossary

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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

International Patents for DAKLINZA

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Country	Patent Number	Estimated Expiration
European Patent Office	3321263	Start Trial
Hungary	E037802	Start Trial
Taiwan	200934486	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for DAKLINZA

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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