DAKLINZA Drug Patent Profile

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:	69
Clinical Trials:	12
Patent Applications:	798
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
Tanta University	Phase 2/Phase 3
Nanjing Sanhome Pharmaceutical, Co., Ltd.	Phase 2/Phase 3
National Institute on Drug Abuse (NIDA)	Phase 2/Phase 3

See all DAKLINZA clinical trials

Anatomical Therapeutic Chemical (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

DAKLINZA is protected by eight US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting 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

International Patents for DAKLINZA

When does loss-of-exclusivity occur for DAKLINZA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Eurasian Patent Organization

European Patent Office

Hong Kong

Israel

Japan

Mexico

New Zealand

Peru

South Africa

South Korea

Spain

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering DAKLINZA around the world.

Country	Patent Number	Title	Estimated Expiration
Taiwan	I359813
China	101778840	Crystalline form of methyl ((1s)-1-(((2s)-2-(5-(4'-(2-((2s)-1-((2s)-2-((methoxycarbonyl)amino)-3-methylbutanoyl)-2-pyrrolidinyl)-1h-imidazol-5-yl)-4-biphenylyl)-1h-imidazol-2-yl)-1-pyrrolidinyl)carbonyl)-2-methylpropyl)carbamate dihydrochloride salt
Argentina	108411	INHIBIDORES DEL VIRUS DE LA HEPATITIS C

Supplementary Protection Certificates for DAKLINZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	1590007-9	Sweden		PRODUCT NAME: DACLATASVIR AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, ESPECIALLY DACLATASVIR DIHYDROCHLORIDE; REG. NO/DATE: EU/1/14/939 20140826
2049522	9/2015	Austria		PRODUCT NAME: DECLATASVIR; REGISTRATION NO/DATE: EU/1/14/939 (MITTEILUNG) 20140826