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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Argus Health
Mallinckrodt
McKesson
Queensland Health
US Department of Justice
Cantor Fitzgerald
Accenture
Colorcon
Chubb

Generated: October 19, 2017

DrugPatentWatch Database Preview

DAKLINZA Drug Profile

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Which patents cover Daklinza, and what generic Daklinza 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.

Summary for Tradename: DAKLINZA

US Patents:5
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list10
Clinical Trials: see list8
Drug Prices:see details
DailyMed Link:DAKLINZA at DailyMed
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;ORAL206843-001Jul 24, 2015RXYesNo► Subscribe► SubscribeYY ► 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► SubscribeY ► Subscribe
Bristol-myers Squibb
DAKLINZA
daclatasvir dihydrochloride
TABLET;ORAL206843-002Jul 24, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
Bristol-myers Squibb
DAKLINZA
daclatasvir dihydrochloride
TABLET;ORAL206843-003Apr 13, 2016RXYesNo► Subscribe► SubscribeY ► Subscribe
Bristol-myers Squibb
DAKLINZA
daclatasvir dihydrochloride
TABLET;ORAL206843-002Jul 24, 2015RXYesYes► Subscribe► SubscribeYY ► Subscribe
Bristol-myers Squibb
DAKLINZA
daclatasvir dihydrochloride
TABLET;ORAL206843-002Jul 24, 2015RXYesYes► Subscribe► Subscribe ► Subscribe
Bristol-myers Squibb
DAKLINZA
daclatasvir dihydrochloride
TABLET;ORAL206843-002Jul 24, 2015RXYesYes► Subscribe► Subscribe► Subscribe
Bristol-myers Squibb
DAKLINZA
daclatasvir dihydrochloride
TABLET;ORAL206843-002Jul 24, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
Bristol-myers Squibb
DAKLINZA
daclatasvir dihydrochloride
TABLET;ORAL206843-001Jul 24, 2015RXYesNo► 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
9,758,487Hepatitis C virus inhibitors► Subscribe
8,303,944Hepatitis C virus inhibitors► Subscribe
8,846,023Hepatitis C virus inhibitors► Subscribe
9,227,961Hepatitis 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
HungaryE029145► Subscribe
Eurasian Patent Organization200900298► Subscribe
Spain2573523► Subscribe
Norway20090447► Subscribe
Japan5769749► Subscribe
World Intellectual Property Organization (WIPO)2009020828► Subscribe
Colombia6160327► Subscribe
Taiwan200934486► Subscribe
Canada2695729► Subscribe
TaiwanI400072► 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
0150003 00128Estonia► SubscribePRODUCT NAME: DAKLATASVIIR;REG NO/DATE: EU/1/14/939 26.08.2014
1 50001-2015Slovakia► SubscribePRODUCT NAME: DAKLATASVIR DIHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/939 - EU/1/14/939/004 20140826
635Luxembourg► SubscribePRODUCT NAME: DACLATASVIR ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES , EN PARTICULIER DICHLORHYDRATE DE DACLATASVIR. FIRST REGISTRATION: 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
2015 00003Denmark► SubscribePRODUCT NAME: DACLATASVIR OG FARMACEUTISK ACCEPTABLE SALTE DERAF, SAERLIGT DACLATASVIR-DIHYDROCHLORID; REG. NO/DATE: EU/1/14/939 20140822
15/002Ireland► SubscribePRODUCT NAME: DACLATASVIR AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, ESPECIALLY DACLATASVIR DIHYDROCHLORIDE; REGISTRATION NO/DATE: EU/14/939/001-004 20140826
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
90007-9Sweden► SubscribePRODUCT NAME: DACLATASVIR AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, ESPECIALLY DACLATASVIR DIHYDROCHLORIDE; REG. NO/DATE: EU/1/14/939 20140826
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:

QuintilesIMS
Cipla
Queensland Health
Fuji
Argus Health
Baxter
Novartis
Teva
Citi
Daiichi Sankyo

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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