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Serving leading biopharmaceutical companies globally:

Accenture
UBS
Novartis
Chinese Patent Office
Merck
Express Scripts
Julphar
Dow
Citi
Medtronic

Generated: January 19, 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-six patent family members in thirty-one countries.

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

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 Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Bristol-myers Squibb DAKLINZA daclatasvir dihydrochloride TABLET;ORAL 206843-001 Jul 24, 2015 RX Yes No ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Bristol-myers Squibb DAKLINZA daclatasvir dihydrochloride TABLET;ORAL 206843-001 Jul 24, 2015 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Bristol-myers Squibb DAKLINZA daclatasvir dihydrochloride TABLET;ORAL 206843-002 Jul 24, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Bristol-myers Squibb DAKLINZA daclatasvir dihydrochloride TABLET;ORAL 206843-003 Apr 13, 2016 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Bristol-myers Squibb DAKLINZA daclatasvir dihydrochloride TABLET;ORAL 206843-001 Jul 24, 2015 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Bristol-myers Squibb DAKLINZA daclatasvir dihydrochloride TABLET;ORAL 206843-002 Jul 24, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Bristol-myers Squibb DAKLINZA daclatasvir dihydrochloride TABLET;ORAL 206843-001 Jul 24, 2015 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Bristol-myers Squibb DAKLINZA daclatasvir dihydrochloride TABLET;ORAL 206843-001 Jul 24, 2015 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Bristol-myers Squibb DAKLINZA daclatasvir dihydrochloride TABLET;ORAL 206843-001 Jul 24, 2015 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
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
9,758,487 Hepatitis C virus inhibitors ➤ Subscribe
8,303,944 Hepatitis C virus inhibitors ➤ Subscribe
8,574,563 Hepatitis C virus inhibitors ➤ Subscribe
9,227,961 Hepatitis C virus inhibitors ➤ Subscribe
8,846,023 Hepatitis C virus inhibitors ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for daclatasvir dihydrochloride

Supplementary Protection Certificates for daclatasvir dihydrochloride

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2015000009 Germany ➤ Subscribe PRODUCT NAME: DACLATASVIR UND PHARMAZEUTISCH AKZEPTABLE SALZE DAVON, INSBESONDERE DACLATASVIR DIHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/939/001-004 20140822
2015006 Lithuania ➤ Subscribe PRODUCT NAME: DACLATASVIRUM; REGISTRATION NO/DATE: EU/1/14/939/001 - EU/1/14/939/004 20140826
2015 00003 Denmark ➤ Subscribe PRODUCT NAME: DACLATASVIR OG FARMACEUTISK ACCEPTABLE SALTE DERAF, SAERLIGT DACLATASVIR-DIHYDROCHLORID; REG. NO/DATE: EU/1/14/939 20140822
C0007 France ➤ Subscribe 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
635 Luxembourg ➤ Subscribe PRODUCT NAME: DACLATASVIR ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES , EN PARTICULIER DICHLORHYDRATE DE DACLATASVIR. FIRST REGISTRATION: 20140826
0713 Netherlands ➤ Subscribe PRODUCT NAME: DACLATASVIR EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN, IN HET BIJZONDER DACLATASVIR DIHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/14/939/001-004 20140826
2015006,C2049522 Lithuania ➤ Subscribe 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
15/002 Ireland ➤ Subscribe PRODUCT NAME: DACLATASVIR AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, ESPECIALLY DACLATASVIR DIHYDROCHLORIDE; REGISTRATION NO/DATE: EU/14/939/001-004 20140826
2015 Austria ➤ Subscribe PRODUCT NAME: DECLATASVIR; REGISTRATION NO/DATE: EU/1/14/939 (MITTEILUNG) 20140826
00713 Netherlands ➤ Subscribe PRODUCT NAME: DACLATASVIR EN FARMACEUTISCH; REGISTRATION NO/DATE: EU/1/14/939/001-004 20150119
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Citi
Chinese Patent Office
US Department of Justice
Moodys
Cipla
Harvard Business School
Argus Health
Fuji
Fish and Richardson

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.

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