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Serving leading biopharmaceutical companies globally:

Medtronic
Citi
QuintilesIMS
Chinese Patent Office
Accenture
Merck
Baxter
Healthtrust
Fish and Richardson
Harvard Business School

Generated: November 18, 2017

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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 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 and thirteen supplementary protection certificates in eleven countries.

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

Summary 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;ORAL206843-002Jul 24, 2015RXYesYes► Subscribe► SubscribeYY ► Subscribe
Bristol-myers Squibb
DAKLINZA
daclatasvir dihydrochloride
TABLET;ORAL206843-002Jul 24, 2015RXYesYes► Subscribe► Subscribe► Subscribe
Bristol-myers Squibb
DAKLINZA
daclatasvir dihydrochloride
TABLET;ORAL206843-003Apr 13, 2016RXYesNo► Subscribe► SubscribeY ► Subscribe
Bristol-myers Squibb
DAKLINZA
daclatasvir dihydrochloride
TABLET;ORAL206843-001Jul 24, 2015RXYesNo► Subscribe► SubscribeY ► Subscribe
Bristol-myers Squibb
DAKLINZA
daclatasvir dihydrochloride
TABLET;ORAL206843-001Jul 24, 2015RXYesNo► Subscribe► Subscribe ► Subscribe
Bristol-myers Squibb
DAKLINZA
daclatasvir dihydrochloride
TABLET;ORAL206843-002Jul 24, 2015RXYesYes► Subscribe► Subscribe► Subscribe
Bristol-myers Squibb
DAKLINZA
daclatasvir dihydrochloride
TABLET;ORAL206843-001Jul 24, 2015RXYesNo► Subscribe► Subscribe► Subscribe
Bristol-myers Squibb
DAKLINZA
daclatasvir dihydrochloride
TABLET;ORAL206843-002Jul 24, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
Bristol-myers Squibb
DAKLINZA
daclatasvir dihydrochloride
TABLET;ORAL206843-002Jul 24, 2015RXYesYes► Subscribe► SubscribeYY ► Subscribe
Bristol-myers Squibb
DAKLINZA
daclatasvir dihydrochloride
TABLET;ORAL206843-001Jul 24, 2015RXYesNo► Subscribe► SubscribeYY ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
8,303,944Hepatitis C virus inhibitors► Subscribe
9,227,961Hepatitis C virus inhibitors► Subscribe
8,846,023Hepatitis C virus inhibitors► Subscribe
8,574,563Hepatitis C virus inhibitors► Subscribe
9,758,487Hepatitis C virus inhibitors► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: daclatasvir dihydrochloride

Country Document Number Estimated Expiration
Eurasian Patent Organization200900298► Subscribe
European Patent Office2784075► Subscribe
Japan5244179► Subscribe
Eurasian Patent Organization015756► Subscribe
South Korea20090040909► Subscribe
Spain2476592► Subscribe
Hong Kong1126486► Subscribe
Australia2007286222► Subscribe
Spain2402791► Subscribe
Japan5769749► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: DACLATASVIR DIHYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2015 00003Denmark► SubscribePRODUCT NAME: DACLATASVIR OG FARMACEUTISK ACCEPTABLE SALTE DERAF, SAERLIGT DACLATASVIR-DIHYDROCHLORID; REG. NO/DATE: EU/1/14/939 20140822
C0007France► SubscribePRODUCT 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
0150003 00128Estonia► SubscribePRODUCT NAME: DAKLATASVIIR;REG NO/DATE: EU/1/14/939 26.08.2014
90007-9Sweden► SubscribePRODUCT NAME: DACLATASVIR AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, ESPECIALLY DACLATASVIR DIHYDROCHLORIDE; REG. NO/DATE: EU/1/14/939 20140826
1 50001-2015Slovakia► SubscribePRODUCT NAME: DAKLATASVIR DIHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/939 - EU/1/14/939/004 20140826
2015006,C2049522Lithuania► SubscribePRODUCT 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
2015006Lithuania► SubscribePRODUCT NAME: DACLATASVIRUM; REGISTRATION NO/DATE: EU/1/14/939/001 - EU/1/14/939/004 20140826
635Luxembourg► SubscribePRODUCT NAME: DACLATASVIR ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES , EN PARTICULIER DICHLORHYDRATE DE DACLATASVIR. FIRST REGISTRATION: 20140826
00713Netherlands► SubscribePRODUCT NAME: DACLATASVIR EN FARMACEUTISCH; REGISTRATION NO/DATE: EU/1/14/939/001-004 20150119
2015Austria► SubscribePRODUCT NAME: DECLATASVIR; REGISTRATION NO/DATE: EU/1/14/939 (MITTEILUNG) 20140826
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Argus Health
Medtronic
McKesson
Julphar
AstraZeneca
Express Scripts
Merck
Federal Trade Commission
Cerilliant
Citi

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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