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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-two 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. Additional details are available on the daclatasvir dihydrochloride profile page.

DrugPatentWatch^® 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

Summary for DAKLINZA

International Patents:	92
US Patents:	5
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	99
Clinical Trials:	11
Patent Applications:	883
Drug Prices:	Drug price information for DAKLINZA
DailyMed Link:	DAKLINZA at DailyMed

See drug prices for DAKLINZA

DrugPatentWatch^® Estimated 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.

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

ATC Classes for DAKLINZA

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

International Patents for DAKLINZA

Country	Patent Number	Estimated Expiration
China	101778840
Norway	340543
Japan	2013151535
Cyprus	1117641

Supplementary Protection Certificates for DAKLINZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2049522	524	Finland
2049522	C 2015 003	Romania		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
2049522	9/2015	Austria		PRODUCT NAME: DECLATASVIR; REGISTRATION NO/DATE: EU/1/14/939 (MITTEILUNG) 20140826
2049522	211 50001-2015	Slovakia		OWNER(S): BRISTOL-MYERS SQUIBB HOLDINGS IRELAND UNLIMITED COMPANY, STEINHAUSEN, CH