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Last Updated: November 30, 2022

Daclatasvir dihydrochloride - Generic Drug Details


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What are the generic drug sources for daclatasvir dihydrochloride and what is the scope of patent protection?

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-two patent family members in thirty-one countries.

There are five drug master file entries for daclatasvir dihydrochloride.

Summary for daclatasvir dihydrochloride
International Patents:92
US Patents:5
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 5
Raw Ingredient (Bulk) Api Vendors: 38
Clinical Trials: 126
Patent Applications: 40
DailyMed Link:daclatasvir dihydrochloride at DailyMed
Recent Clinical Trials for daclatasvir dihydrochloride

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

SponsorPhase
Tanta UniversityPhase 3
University of OxfordN/A
Aga Khan UniversityN/A

See all daclatasvir dihydrochloride clinical trials

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 206843-002 Jul 24, 2015 DISCN Yes No See Plans and Pricing See Plans and Pricing Y 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
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 Y 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 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
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
>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 daclatasvir dihydrochloride

Country Patent Number Title Estimated Expiration
Japan 2013151535 HEPATITIS C VIRUS INHIBITORS See Plans and Pricing
Luxembourg 92635 See Plans and Pricing
Argentina 104566 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 See Plans and Pricing
European Patent Office 2385048 Inhibiteurs du virus de l'h├ępatite C (Hepatitis C virus inhibitors) 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
Cyprus 1115594 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for daclatasvir dihydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2049522 C02049522/01 Switzerland See Plans and Pricing ADRESSAENDERUNG
2049522 524 Finland See Plans and Pricing
2049522 15C0007 France See Plans and Pricing 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 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 92635 Luxembourg See Plans and Pricing PRODUCT NAME: DACLATASVIR ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES , EN PARTICULIER DICHLORHYDRATE DE DACLATASVIR. FIRST REGISTRATION: 20140826
2049522 C20150003 00128 Estonia See Plans and Pricing PRODUCT NAME: DAKLATASVIIR;REG NO/DATE: EU/1/14/939 26.08.2014
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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