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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Merck
Johnson and Johnson
AstraZeneca
Fuji
Mallinckrodt
US Army
UBS
Chubb

Generated: July 21, 2018

DrugPatentWatch Database Preview

Daclatasvir dihydrochloride - Generic Drug Details

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What are the generic sources for daclatasvir dihydrochloride and what is the scope of daclatasvir dihydrochloride 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 seventy-eight patent family members in thirty-one countries.

There are three drug master file entries for daclatasvir dihydrochloride. One supplier is listed for this compound.
Summary for daclatasvir dihydrochloride
International Patents:78
US Patents:5
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 3
Suppliers / Packagers: 1
Bulk Api Vendors: 24
Clinical Trials: 95
Patent Applications: 1
DailyMed Link:daclatasvir dihydrochloride at DailyMed
Synonyms for daclatasvir dihydrochloride
1009119-65-6
50ZO25C11D
AC-28423
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 2HCl
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
MFCD25541736
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 206843-002 Jul 24, 2015 RX Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Bristol-myers Squibb DAKLINZA daclatasvir dihydrochloride TABLET;ORAL 206843-001 Jul 24, 2015 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Bristol-myers Squibb DAKLINZA daclatasvir dihydrochloride TABLET;ORAL 206843-001 Jul 24, 2015 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Bristol-myers Squibb DAKLINZA daclatasvir dihydrochloride TABLET;ORAL 206843-001 Jul 24, 2015 RX Yes No ➤ Sign Up ➤ Sign Up Y 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

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Non-Orange Book US Patents for daclatasvir dihydrochloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,303,944 Hepatitis C virus inhibitors ➤ Sign Up
8,574,563 Hepatitis C virus inhibitors ➤ Sign Up
8,846,023 Hepatitis C virus inhibitors ➤ Sign Up
9,227,961 Hepatitis C virus inhibitors ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for daclatasvir dihydrochloride

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2015 00003 Denmark ➤ Sign Up PRODUCT NAME: DACLATASVIR OG FARMACEUTISK ACCEPTABLE SALTE DERAF, SAERLIGT DACLATASVIR-DIHYDROCHLORID; REG. NO/DATE: EU/1/14/939 20140822
2015006,C2049522 Lithuania ➤ Sign Up 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
0713 Netherlands ➤ Sign Up PRODUCT NAME: DACLATASVIR EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN, IN HET BIJZONDER DACLATASVIR DIHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/14/939/001-004 20140826
2015000009 Germany ➤ Sign Up PRODUCT NAME: DACLATASVIR UND PHARMAZEUTISCH AKZEPTABLE SALZE DAVON, INSBESONDERE DACLATASVIR DIHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/939/001-004 20140822
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Teva
Moodys
Citi
Argus Health
Dow
Boehringer Ingelheim
Accenture
AstraZeneca

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 verifification 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.