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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 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

International Patents:	78
US Patents:	5
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	27
Clinical Trials:	9
Patent Applications:	1
Drug Prices:	Drug price information for DAKLINZA
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

1009119-65-6

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		RX	Yes	No				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	Y
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

International Patents for DAKLINZA

Country	Patent Number	Estimated Expiration
Argentina	070016
European Patent Office	3042901
Norway	20090447
Portugal	2049522
South Korea	101450352

Supplementary Protection Certificates for DAKLINZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2049522	92635	Luxembourg		PRODUCT NAME: DACLATASVIR ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES , EN PARTICULIER DICHLORHYDRATE DE DACLATASVIR. FIRST REGISTRATION: 20140826
2049522	C300713	Netherlands		PRODUCT NAME: DACLATASVIR EN FARMACEUTISCH; REGISTRATION NO/DATE: EU/1/14/939/001-004 20150119
2049522	122015000009	Germany		PRODUCT NAME: DACLATASVIR UND PHARMAZEUTISCH AKZEPTABLE SALZE DAVON, INSBESONDERE DACLATASVIR DIHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/939/001-004 20140822
2049522	1590007-9	Sweden		PRODUCT NAME: DACLATASVIR AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, ESPECIALLY DACLATASVIR DIHYDROCHLORIDE; REG. NO/DATE: EU/1/14/939 20140826
2049522	PA2015006	Lithuania		PRODUCT NAME: DACLATASVIRUM; REGISTRATION NO/DATE: EU/1/14/939/001 - EU/1/14/939/004 20140826