Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

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Last Updated: November 19, 2019

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Daclatasvir dihydrochloride - Generic Drug Details

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What are the generic sources for daclatasvir dihydrochloride and what is the scope of freedom to operate?

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 eighty-nine patent family members in thirty-one countries.

There are five drug master file entries for daclatasvir dihydrochloride. One supplier is listed for this compound.

Summary for daclatasvir dihydrochloride
International Patents:89
US Patents:5
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 5
Suppliers / Packagers: 1
Bulk Api Vendors: 33
Clinical Trials: 117
Patent Applications: 3
DailyMed Link:daclatasvir dihydrochloride at DailyMed
Recent Clinical Trials for daclatasvir dihydrochloride

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SponsorPhase
Atea Pharmaceuticals, Inc.Phase 2
Assiut UniversityEarly Phase 1
Nanjing Sanhome Pharmaceutical, Co., Ltd.Phase 2/Phase 3

See all daclatasvir dihydrochloride clinical trials

Synonyms for daclatasvir dihydrochloride
1009119-65-6
50ZO25C11D
AC-28423
AK546321
AKOS030632774
AOB87340
BMS 790052
BMS 790052 (di HClsalt)
BMS 790052-05
BMS-790052
BMS-790052 (dihydrochloride)
BMS-790052 dihydrochloride
BMS-790052-05
BMS790052 dihydrochloride
CHEBI:83800
CHEMBL2303621
CS-0270
D10105
Daclatasvir (dihydrochloride)
Daclatasvir dihydrochloride (BMS-790052)
Daclatasvir dihydrochloride (USAN)
daclatasvir hydrochloride
Daclatasvir hydrochloride (JAN)
Daklinza
Daklinza (TN)
dimethyl ((2S,2'S)-((2S,2'S)-2,2'-(5,5'-([1,1'-biphenyl]-4,4'-diyl)bis(1H-imidazole-5,2-diyl))bis(pyrrolidine-2,1-diyl))bis(3-methyl-1-oxobutane-2,1-diyl))dicarbamate dihydrochloride
Dimethyl N,N'-(biphenyl-4,4'-diylbis(1H-imidazole-5,2-diyl-((2S)-pyrrolidine-2,1- diyl)((1S)-1-(1-methylethyl)-2-oxoethane-2,1-diyl)))dicarbamate dihydrochloride
HY-10465
KS-00000P35
methyl [(2S)-1-{(2S)-2-[4-(4'-{2-[(2S)-1-{(2S)-2-[(methoxycarbonyl)amino]-3-methylbutanoyl}pyrrolidin-2-yl]-1H-imidazol-4-yl}biphenyl-4-yl)-1H-imidazol-2-yl]pyrrolidin-1-yl}-3-methyl-1-oxobutan-2-yl]carbamate dihydrochloride
MolPort-042-665-812
SCHEMBL17870647
UNII-50ZO25C11D
W-6070

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 206843-001 Jul 24, 2015 DISCN Yes No   Start Trial   Start Trial   Start Trial
Bristol-myers Squibb DAKLINZA daclatasvir dihydrochloride TABLET;ORAL 206843-002 Jul 24, 2015 DISCN Yes No   Start Trial   Start Trial Y Y   Start Trial
Bristol-myers Squibb DAKLINZA daclatasvir dihydrochloride TABLET;ORAL 206843-003 Apr 13, 2016 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for daclatasvir dihydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2049522 PA2015006,C2049522 Lithuania   Start Trial PRODUCT NAME: DAKLATASVIRAS IR JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS, YPAC DAKLATASVIRO HIDROCHLORIDAS; REGISTRATION NO/DATE: EU/1/14/939/001 - EU/1/14/939/004, 0140822
2049522 PA2015006 Lithuania   Start Trial PRODUCT NAME: DACLATASVIRUM; REGISTRATION NO/DATE: EU/1/14/939/001 - EU/1/14/939/004 20140826
2049522 C 2015 003 Romania   Start Trial PRODUCT NAME: DACLATASVIR SI SARURILE ACCEPTABILE FARMACEUTIC ALEACESTUIA, IN SPECIAL DACLATASVIR DICLORHIDRAT; NATIONAL AUTHORISATION NUMBER: EU/1/14/939/001, EU/1/14/939/002, EU/1/14/939/003, EU/1/14/939/004; DATE OF NATIONAL AUTHORISATION: 20140822; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/939/001, EU/1/14/939/002, EU/1/14/939/003, EU/1/14/939/004; DATE OF FIRST AUTHORISATION IN EEA: 20140822
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
AstraZeneca
Mallinckrodt
Harvard Business School
Dow
Moodys

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