Daclatasvir dihydrochloride - Generic Drug Details

What are the generic sources for daclatasvir dihydrochloride and what is the scope of freedom to operate?

Daclatasvir dihydrochloride is the generic ingredient in one branded drug marketed by Bristol-myers Squibb and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Daclatasvir dihydrochloride has ninety-three patent family members in thirty-one countries.

There are five drug master file entries for daclatasvir dihydrochloride.

Summary for daclatasvir dihydrochloride

International Patents:	93
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	5
Raw Ingredient (Bulk) Api Vendors:	135
Clinical Trials:	127
Patent Applications:	1,327
DailyMed Link:	daclatasvir dihydrochloride at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for daclatasvir dihydrochloride

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 daclatasvir dihydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Tanta University	Phase 3
Ain Shams University	Phase 3
Aga Khan University	N/A

See all daclatasvir dihydrochloride clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for daclatasvir dihydrochloride

J05AP	Antivirals for treatment of HCV infections
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for daclatasvir dihydrochloride

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

International Patents for daclatasvir dihydrochloride

Country	Patent Number	Title	Estimated Expiration
Australia	2007286222	Hepatitis C virus inhibitors
Brazil	PI0716483	inibidores do vírus da hepatite c
Japan	2015172064	Ｃ型肝炎ウイルス阻害剤 (HEPATITIS C VIRUS INHIBITORS)
Colombia	6150171	INHIBODORES DEL VIRUS DE LA HEPATITIS C
Chile	2008002354	Forma cristalina de la sal diclorhidrato de ((1s)-1-(((2s)-2-(5-(4'-(2-((2s)-1-((2s)-2-((metoxicarbonil)amino)-3-metilbutanoil)-2-pirrolidinil)-1h-imidazol-5-il)-4-bifenilil)-1h-imidazol-2-il)-1-pirrolidinil)carbonil)-2-metilpropil)carbamato de metilo; composición y combinacion farmacéutica; y su uso para tratar la hepatitis c.
Japan	2010500413
European Patent Office	2784075	Inhibiteurs du virus de l'hépatite C (Hepatitis C virus inhibitors)

Supplementary Protection Certificates for daclatasvir dihydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2049522	C20150003 00128	Estonia		PRODUCT NAME: DAKLATASVIIR;REG NO/DATE: EU/1/14/939 26.08.2014
2049522	92635	Luxembourg		PRODUCT NAME: DACLATASVIR ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES , EN PARTICULIER DICHLORHYDRATE DE DACLATASVIR. FIRST REGISTRATION: 20140826
2049522	CR 2015 00003	Denmark		PRODUCT NAME: DACLATASVIR OG FARMACEUTISK ACCEPTABLE SALTE DERAF, SAERLIGT DACLATASVIR-DIHYDROCHLORID; REG. NO/DATE: EU/1/14/939 20140826
2049522	CA 2015 00003	Denmark		PRODUCT NAME: DACLATASVIR OG FARMACEUTISK ACCEPTABLE SALTE DERAF, SAERLIGT DACLATASVIR-DIHYDROCHLORID; REG. NO/DATE: EU/1/14/939 20140822
2049522	C02049522/01	Switzerland		ADRESSAENDERUNG
2049522	300713	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF OWNER(S) NAME
2049522	211 50001-2015	Slovakia		PRODUCT NAME: DAKLATASVIR DIHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/939 - EU/1/14/939/004 20140826