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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 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

International Patents:	78
US Patents:	5
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	24
Clinical Trials:	8
Patent Applications:	100
DailyMed Link:	DAKLINZA at DailyMed

Generic Entry Opportunity Date for DAKLINZA

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.

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

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			Y	Y
Bristol-myers Squibb	DAKLINZA	daclatasvir dihydrochloride	TABLET;ORAL	206843-002	Jul 24, 2015		RX	Yes	No			Y	Y
Bristol-myers Squibb	DAKLINZA	daclatasvir dihydrochloride	TABLET;ORAL	206843-001	Jul 24, 2015		RX	Yes	No				Y
Bristol-myers Squibb	DAKLINZA	daclatasvir dihydrochloride	TABLET;ORAL	206843-002	Jul 24, 2015		RX	Yes	No				Y

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Non-Orange Book US Patents for DAKLINZA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
9,758,487	Hepatitis C virus inhibitors
8,303,944	Hepatitis C virus inhibitors
8,846,023	Hepatitis C virus inhibitors
9,227,961	Hepatitis C virus inhibitors

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International Patents for DAKLINZA

Country	Document Number	Estimated Expiration
Israel	196813
Australia	2007286222
Peru	09402009
Eurasian Patent Organization	200900298

Supplementary Protection Certificates for DAKLINZA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2015 00003	Denmark		PRODUCT NAME: DACLATASVIR OG FARMACEUTISK ACCEPTABLE SALTE DERAF, SAERLIGT DACLATASVIR-DIHYDROCHLORID; REG. NO/DATE: EU/1/14/939 20140822
2015006,C2049522	Lithuania		PRODUCT NAME: DAKLATASVIRAS IR JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS, YPAC DAKLATASVIRO HIDROCHLORIDAS; REGISTRATION NO/DATE: EU/1/14/939/001 - EU/1/14/939/004, 0140822
0713	Netherlands		PRODUCT NAME: DACLATASVIR EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN, IN HET BIJZONDER DACLATASVIR DIHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/14/939/001-004 20140826
2015000009	Germany		PRODUCT NAME: DACLATASVIR UND PHARMAZEUTISCH AKZEPTABLE SALZE DAVON, INSBESONDERE DACLATASVIR DIHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/939/001-004 20140822