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Last Updated: November 21, 2024

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

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
Ain Shams UniversityPhase 3
Cairo UniversityPhase 3
Tanta UniversityPhase 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 ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF INHIBITING HEPATITIS C VIRUS

Hepatitis C virus inhibitors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF INHIBITING HEPATITIS C VIRUS

Hepatitis C virus inhibitors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF INHIBITING HEPATITIS C VIRUS

Hepatitis C virus inhibitors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bristol-myers Squibb DAKLINZA daclatasvir dihydrochloride TABLET;ORAL 206843-001 Jul 24, 2015 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Bristol-myers Squibb DAKLINZA daclatasvir dihydrochloride TABLET;ORAL 206843-002 Jul 24, 2015 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Bristol-myers Squibb DAKLINZA daclatasvir dihydrochloride TABLET;ORAL 206843-001 Jul 24, 2015 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Bristol-myers Squibb DAKLINZA daclatasvir dihydrochloride TABLET;ORAL 206843-002 Jul 24, 2015 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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
Patent: FORMA CRISTALINA DE LA SAL DICLORHIDRATO DE ((1S)-1-(((2S)-2-(5-(4'-(2-((2S)-1-((2S)-2-((METOXICARBONIL)AMINO)-3-METILBUTANO IL)-2-PIRROLIDINIL)-1H-IMIDAZOL-5-IL)-4-BIFENILIL)-1H-IMIDAZOL-2-IL)-1-PIRROLIDINIL)CARBONIL)-2-METILPROPIL)CARBAMATO DE METILO
Estimated Expiration: ⤷  Sign Up

Patent: 4566
Patent: 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
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 08284100
Patent: 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
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0815142
Patent: FORMA CRISTALINA DO SAL DE DICLORIDRATO ((1S)-1-(((2S)-2-(5-(4'-(2-((2S)-1-((2S)-2-((METOXICARBONIL)-3-MET ILBUTANOIL)-2-PIRROLIDINIL)-1H-IMIDAZOL-5-IL)-4-BIFENILIL)- 1H-IMIDAZOL-2-IL)-1-PIRROLIDINIL)CARBONIL)-2-METELPROPI L)CARBAMATO DE METILA
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 95729
Patent: FORME CRISTALLINE DE DIHYDROCHLORURE DE 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 (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)
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 08002354
Patent: 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.
Estimated Expiration: ⤷  Sign Up

China

Patent: 1778840
Patent: 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
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 60327
Patent: FORMA CRISTALINA DE LA SAL DICLORHIDRATO DE ((2S)-2-(5-(4`-(2((2S)-1-((2S)-2-((METOXICARBONIL)AMINO)-3-METILBUTANIOL)-2-PIRROLIDINIL)-1H-IMIDAZOL-5-IL-4BIFENILIL)-1H-IMIDAZOL-2-IL)-1-PIRROLIDINIL)CARBONIL)-2-METILPROPIL)CARBAMATO DE METILO
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 8152
Patent: КРИСТАЛЛИЧЕСКАЯ ФОРМА ДИГИДРОХЛОРИДА МЕТИЛ ((1S)-1-(((2S)-2-(5-(4'-(2-((2S)-1-((2S)-2-((МЕТОКСИКАРБОНИЛ)АМИНО)-3-МЕТИЛБУТАНОИЛ)-2-ПИРРОЛИДИНИЛ)-1Н-ИМИДАЗОЛ-5-ИЛ)-4-БИФЕНИЛИЛ)-1Н-ИМИДАЗОЛ-2-ИЛ)-1-ПИРРОЛИДИНИЛ)КАРБОНИЛ)-2-МЕТИЛПРОПИЛ)КАРБАМАТА (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)
Estimated Expiration: ⤷  Sign Up

Patent: 1000196
Patent: КРИСТАЛЛИЧЕСКАЯ ФОРМА ДИГИДРОХЛОРИДА МЕТИЛ((1S)-1-(((2S)-2-(5-(4'-(2-((2S)-1-((2S)-2-((МЕТОКСИКАРБОНИЛ)АМИНО)-3-МЕТИЛБУТАНОИЛ)-2-ПИРРОЛИДИНИЛ)-1Н-ИМИДАЗОЛ-5-ИЛ)-4-БИФЕНИЛИЛ)-1Н-ИМИДАЗОЛ-2-ИЛ)-1-ПИРРОЛИДИНИЛ)КАРБОНИЛ)-2-МЕТИЛПРОПИЛ)КАРБАМАТА
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 83244
Patent: FORME CRISTALLINE DE DIHYDROCHLORURE DE MÉTHYL ((1S)-1-(((2S>2-(5-(4'-(2-((2S)-1-((2S)-2-((MÉTHOXYCARBONYL)AMINO)-3-MÉTHYLBUTANOYL)-2-PYRROLIDINYL)-1H-IMIDAZOL-5-YL)-4-BIPHÉNYLYL)-1H-IMIDAZOL-2-YL)-1-PYRROLIDINYL)CARBONYL)-2-MÉTHYLPROPYL)CARBAMATE (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)
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 44089
Patent: 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
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 3684
Patent: צורות גבישייות של מלחי מיטל ((s1) - 1 - (((s2) - 2 - (5 - ('4 (2 - ((s2) - 1 - ((s2) - 2 - ((מטוקסיקרבוניל) אמינו) - 3 - מטילביוטאנויל) - 2 - פירולידיניל) - h1 - אמידאזול - 5 - איל) - 4 - ביפניליל) - h1 - אימידאזול - 2 - איל) - 1 - פירולידיניל) קרבוניל)-2-מטילפרופיל) קרבמט דיהידרוכלור (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)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 44179
Estimated Expiration: ⤷  Sign Up

Patent: 10535785
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 10001368
Patent: FORMA CRISTALINA DE LA SAL DICLORHIDRATO DE ((1S)-1-(((2S)-2-(5-(4 ́-(2-((2S)-1-((2S)-2-((METOXICARBONIL) AMINO)-3-METILBUTANOIL)-2-P IRROLIDINIL)-1H-IMIDAZOL-5-IL)-4-BIFENILIL)-1H-IMIDAZOL-2-IL)-1-P IRROLIDINIL) CARBONIL)-2-METILPROPIL)CARBAMATO DE (CRYSTALLINE FORM OF METHYL ((1S)-1-(((2S)-2-(5-(4'-(2-((2S)-1-((2 S)-2-((METHOXYCARBONYL)AMINO)-3-METHYLBUTANOYL)-2-PYRROLIDINYL)- 1H-IMIDAZOL-5-YL)-4-BIPHENYLYL)-1H-IMIDAZOL-2-YL)-1-PYRROLIDINYL )CARBONYL)-2-METHYLPROPYL)CARBAMATE DIHYDROCHLORIDE SA)
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 3148
Patent: 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
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 090940
Patent: 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 METIL
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1000843
Patent: 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
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1508022
Estimated Expiration: ⤷  Sign Up

Patent: 100042641
Patent: 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
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 02791
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 59813
Estimated Expiration: ⤷  Sign Up

Patent: 0911790
Patent: 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
Estimated Expiration: ⤷  Sign Up

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
Chile 2007002327 COMPUESTOS DERIVADOS DE FENIL-IMIDAZOL SUSTITUIDO; COMPOSICION FARMACEUTICA; Y USO EN EL TRATAMIENTO DEL VHC. ⤷  Sign Up
Taiwan 200813029 Hepatitis C virus inhibitors ⤷  Sign Up
Croatia P20180496 ⤷  Sign Up
Canada 2695729 FORME CRISTALLINE DE DIHYDROCHLORURE DE 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 (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) ⤷  Sign Up
South Korea 101475189 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for DAKLINZA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2049522 2015/002 Ireland ⤷  Sign Up PRODUCT NAME: DACLATASVIR AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, ESPECIALLY DACLATASVIR DIHYDROCHLORIDE; REGISTRATION NO/DATE: EU/14/939/001-004 20140826
2049522 211 50001-2015 Slovakia ⤷  Sign Up PRODUCT NAME: DAKLATASVIR DIHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/939 - EU/1/14/939/004 20140826
2049522 15C0007 France ⤷  Sign Up PRODUCT NAME: DACLATASVIR ET DES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI,EN PARTICULIER LE SEL DE DICHLORHYDRATE DE DACLATASVIR; REGISTRATION NO/DATE: EU/1/14/939/001 20140826
2049522 300713 Netherlands ⤷  Sign Up DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF OWNER(S) NAME
2049522 CA 2015 00003 Denmark ⤷  Sign Up PRODUCT NAME: DACLATASVIR OG FARMACEUTISK ACCEPTABLE SALTE DERAF, SAERLIGT DACLATASVIR-DIHYDROCHLORID; REG. NO/DATE: EU/1/14/939 20140822
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.