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Last Updated: March 1, 2024

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: 135
Clinical Trials: 127
Patent Applications: 1,327
DailyMed Link:daclatasvir dihydrochloride at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for daclatasvir dihydrochloride
Generic Entry Date for daclatasvir dihydrochloride*:
Constraining patent/regulatory exclusivity:
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 daclatasvir dihydrochloride

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

SponsorPhase
Tanta UniversityPhase 3
Ain Shams UniversityPhase 3
University of OxfordN/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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Bristol-myers Squibb DAKLINZA daclatasvir dihydrochloride TABLET;ORAL 206843-001 Jul 24, 2015 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Bristol-myers Squibb DAKLINZA daclatasvir dihydrochloride TABLET;ORAL 206843-001 Jul 24, 2015 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bristol-myers Squibb DAKLINZA daclatasvir dihydrochloride TABLET;ORAL 206843-001 Jul 24, 2015 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Bristol-myers Squibb DAKLINZA daclatasvir dihydrochloride TABLET;ORAL 206843-002 Jul 24, 2015 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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
European Patent Office 2385048 Inhibiteurs du virus de l'hépatite C (Hepatitis C virus inhibitors) ⤷  Try a Trial
European Patent Office 3321263 COMPOSÉS POUR LA PRÉPARATION D'INHIBITEURS DU VIRUS DE L'HÉPATITE C (COMPOUNDS FOR PREPARING HEPATITIS C VIRUS INHIBITORS) ⤷  Try a Trial
Norway 2017036 ⤷  Try a Trial
Poland 2784075 ⤷  Try a Trial
Croatia P20140737 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for daclatasvir dihydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2049522 524 Finland ⤷  Try a Trial
2049522 PA2015006 Lithuania ⤷  Try a Trial PRODUCT NAME: DACLATASVIRUM; REGISTRATION NO/DATE: EU/1/14/939/001 - EU/1/14/939/004 20140826
2049522 1590007-9 Sweden ⤷  Try a Trial PRODUCT NAME: DACLATASVIR AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, ESPECIALLY DACLATASVIR DIHYDROCHLORIDE; REG. NO/DATE: EU/1/14/939 20140826
2049522 C300713 Netherlands ⤷  Try a Trial PRODUCT NAME: DACLATASVIR EN FARMACEUTISCH; REGISTRATION NO/DATE: EU/1/14/939/001-004 20150119
2049522 300713 Netherlands ⤷  Try a Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF OWNER(S) NAME
>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.