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Last Updated: October 1, 2022

DAKLINZA Drug Patent Profile


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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

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Summary for DAKLINZA
Drug patent expirations by year for DAKLINZA
Drug Prices for DAKLINZA

See drug prices for DAKLINZA

DrugPatentWatch® Estimated Generic Entry Opportunity Date for DAKLINZA
Generic Entry Date for DAKLINZA*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Tanta UniversityPhase 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

US Patents and Regulatory Information for DAKLINZA

DAKLINZA is protected by eight US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of DAKLINZA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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

Hepatitis C virus inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Crystalline form of methyl ((1S)-1-((25)-2-(5-(4'-(2-((25)-1((2S)-2-((methoxycarbonyl)amino)-3-methy- lbutanoyl)-2-pyrrolidinyl)-1H-imidazol-2-yl)-1-pyrrolidinyl)carbonyl)-2-me- thylpropyl)carbamate dihydrochloride salt
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF INHIBITING HEPATITIS C VIRUS

Hepatitis C virus inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF INHIBITING HEPATITIS C VIRUS

Hepatitis C virus inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF INHIBITING HEPATITIS C VIRUS WITH DAKLINZA AND AT LEAST ONE ADDITIONAL COMPOUND HAVING ANTI-HCV ACTIVITY

Hepatitis C virus inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF INHIBITING HEPATITIS C VIRUS WITH DAKLINZA AND AT LEAST ONE ADDITIONAL COMPOUND HAVING ANTI-HCV ACTIVITY

Hepatitis C virus inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF INHIBITING HEPATITIS C VIRUS

Hepatitis C virus inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF INHIBITING HEPATITIS C VIRUS WITH DAKLINZA AND AT LEAST ONE ADDITIONAL COMPOUND HAVING ANTI-HCV ACTIVITY

Hepatitis C virus inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF INHIBITING HEPATITIS C VIRUS

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bristol-myers Squibb DAKLINZA daclatasvir dihydrochloride TABLET;ORAL 206843-001 Jul 24, 2015 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Bristol-myers Squibb DAKLINZA daclatasvir dihydrochloride TABLET;ORAL 206843-002 Jul 24, 2015 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

Patent: 0016
Estimated Expiration: See Plans and Pricing

Patent: 4566
Estimated Expiration: See Plans and Pricing

Australia

Patent: 08284100
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0815142
Estimated Expiration: See Plans and Pricing

Canada

Patent: 95729
Estimated Expiration: See Plans and Pricing

Chile

Patent: 08002354
Estimated Expiration: See Plans and Pricing

China

Patent: 1778840
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 60327
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 8152
Estimated Expiration: See Plans and Pricing

Patent: 1000196
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 83244
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 44089
Estimated Expiration: See Plans and Pricing

Israel

Patent: 3684
Estimated Expiration: See Plans and Pricing

Japan

Patent: 44179
Estimated Expiration: See Plans and Pricing

Patent: 10535785
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 10001368
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 3148
Estimated Expiration: See Plans and Pricing

Peru

Patent: 090940
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1000843
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1508022
Estimated Expiration: See Plans and Pricing

Patent: 100042641
Estimated Expiration: See Plans and Pricing

Spain

Patent: 02791
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 59813
Estimated Expiration: See Plans and Pricing

Patent: 0911790
Estimated Expiration: See Plans and Pricing

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 See Plans and Pricing
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 See Plans and Pricing
Argentina 108411 INHIBIDORES DEL VIRUS DE LA HEPATITIS C See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for DAKLINZA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2049522 CA 2015 00003 Denmark See Plans and Pricing PRODUCT NAME: DACLATASVIR OG FARMACEUTISK ACCEPTABLE SALTE DERAF, SAERLIGT DACLATASVIR-DIHYDROCHLORID; REG. NO/DATE: EU/1/14/939 20140822
2049522 1590007-9 Sweden See Plans and Pricing PRODUCT NAME: DACLATASVIR AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, ESPECIALLY DACLATASVIR DIHYDROCHLORIDE; REG. NO/DATE: EU/1/14/939 20140826
2049522 9/2015 Austria See Plans and Pricing PRODUCT NAME: DECLATASVIR; REGISTRATION NO/DATE: EU/1/14/939 (MITTEILUNG) 20140826
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
McKesson
Boehringer Ingelheim
McKinsey
Dow
Harvard Business School

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.