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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
AstraZeneca
Colorcon
Express Scripts
Argus Health
Novartis
McKinsey
Daiichi Sankyo
Chubb
Teva

Generated: December 11, 2017

DrugPatentWatch Database Preview

DAKLINZA Drug Profile

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Which patents cover Daklinza, and what generic alternatives are available?

Daklinza is a drug marketed by Bristol-myers Squibb and is included in one NDA. There are five patents protecting this drug.

This drug has seventy-six patent family members in thirty-one countries and thirteen supplementary protection certificates in eleven countries.

The generic ingredient in DAKLINZA is daclatasvir dihydrochloride. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the daclatasvir dihydrochloride profile page.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Bristol-myers SquibbDAKLINZAdaclatasvir dihydrochlorideTABLET;ORAL206843-001Jul 24, 2015RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Bristol-myers SquibbDAKLINZAdaclatasvir dihydrochlorideTABLET;ORAL206843-002Jul 24, 2015RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Bristol-myers SquibbDAKLINZAdaclatasvir dihydrochlorideTABLET;ORAL206843-001Jul 24, 2015RXYesNo► Subscribe► Subscribe► SubscribeYY► Subscribe
Bristol-myers SquibbDAKLINZAdaclatasvir dihydrochlorideTABLET;ORAL206843-001Jul 24, 2015RXYesNo► Subscribe► Subscribe► SubscribeYY► Subscribe
Bristol-myers SquibbDAKLINZAdaclatasvir dihydrochlorideTABLET;ORAL206843-002Jul 24, 2015RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Bristol-myers SquibbDAKLINZAdaclatasvir dihydrochlorideTABLET;ORAL206843-003Apr 13, 2016RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Bristol-myers SquibbDAKLINZAdaclatasvir dihydrochlorideTABLET;ORAL206843-002Jul 24, 2015RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Bristol-myers SquibbDAKLINZAdaclatasvir dihydrochlorideTABLET;ORAL206843-002Jul 24, 2015RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Bristol-myers SquibbDAKLINZAdaclatasvir dihydrochlorideTABLET;ORAL206843-001Jul 24, 2015RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Bristol-myers SquibbDAKLINZAdaclatasvir dihydrochlorideTABLET;ORAL206843-001Jul 24, 2015RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
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Non-Orange Book Patents for Tradename: DAKLINZA

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
9,758,487Hepatitis C virus inhibitors► Subscribe
8,846,023Hepatitis C virus inhibitors► Subscribe
8,574,563Hepatitis 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 Tradename: DAKLINZA

Country Document Number Estimated Expiration
Peru09402009► Subscribe
Japan2010500413► Subscribe
CroatiaP20160410► Subscribe
Japan5244179► Subscribe
Norway340543► Subscribe
Eurasian Patent Organization201000196► Subscribe
Eurasian Patent Organization015756► Subscribe
Hong Kong1144089► Subscribe
TaiwanI359813► Subscribe
Spain2573523► 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: DAKLINZA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00713Netherlands► SubscribePRODUCT NAME: DACLATASVIR EN FARMACEUTISCH; REGISTRATION NO/DATE: EU/1/14/939/001-004 20150119
15/002Ireland► SubscribePRODUCT NAME: DACLATASVIR AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, ESPECIALLY DACLATASVIR DIHYDROCHLORIDE; REGISTRATION NO/DATE: EU/14/939/001-004 20140826
2015000009Germany► SubscribePRODUCT NAME: DACLATASVIR UND PHARMAZEUTISCH AKZEPTABLE SALZE DAVON, INSBESONDERE DACLATASVIR DIHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/939/001-004 20140822
90007-9Sweden► SubscribePRODUCT NAME: DACLATASVIR AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, ESPECIALLY DACLATASVIR DIHYDROCHLORIDE; REG. NO/DATE: EU/1/14/939 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
635Luxembourg► SubscribePRODUCT NAME: DACLATASVIR ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES , EN PARTICULIER DICHLORHYDRATE DE DACLATASVIR. FIRST REGISTRATION: 20140826
2015Austria► SubscribePRODUCT NAME: DECLATASVIR; REGISTRATION NO/DATE: EU/1/14/939 (MITTEILUNG) 20140826
0150003 00128Estonia► SubscribePRODUCT NAME: DAKLATASVIIR;REG NO/DATE: EU/1/14/939 26.08.2014
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
0713Netherlands► SubscribePRODUCT NAME: DACLATASVIR EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN, IN HET BIJZONDER DACLATASVIR DIHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/14/939/001-004 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:

Chinese Patent Office
Argus Health
US Army
Accenture
Daiichi Sankyo
Teva
Queensland Health
Colorcon
Covington
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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