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Generated: September 20, 2017

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 sixty-nine 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 Generic Name: daclatasvir dihydrochloride

Tradenames:1
Patents:5
Applicants:1
NDAs:1
Drug Master File Entries: see list2
Suppliers / Packagers: see list1
Bulk Api Vendors: see list11
Clinical Trials: see list157
Patent Applications: see list1
Drug Prices:see low prices
DailyMed Link:daclatasvir dihydrochloride 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► 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► Subscribe► 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► SubscribeYY ► Subscribe
Bristol-myers Squibb
DAKLINZA
daclatasvir dihydrochloride
TABLET;ORAL206843-001Jul 24, 2015RXYesNo► Subscribe► Subscribe ► 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;ORAL206843-002Jul 24, 2015RXYesYes► Subscribe► Subscribe► 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
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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
Taiwan200911790► Subscribe
Denmark2784075► Subscribe
Colombia6150171► Subscribe
Israel203684► Subscribe
New Zealand574805► Subscribe
BrazilPI0815142► Subscribe
Mexico2010001368► Subscribe
South Korea20100042641► Subscribe
Colombia6160327► Subscribe
Hong Kong1144089► 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
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
1 50001-2015Slovakia► SubscribePRODUCT NAME: DAKLATASVIR DIHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/939 - EU/1/14/939/004 20140826
2015Austria► SubscribePRODUCT NAME: DECLATASVIR; REGISTRATION NO/DATE: EU/1/14/939 (MITTEILUNG) 20140826
635Luxembourg► SubscribePRODUCT NAME: DACLATASVIR ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES , EN PARTICULIER DICHLORHYDRATE DE DACLATASVIR. FIRST REGISTRATION: 20140826
2015 00003Denmark► SubscribePRODUCT NAME: DACLATASVIR OG FARMACEUTISK ACCEPTABLE SALTE DERAF, SAERLIGT DACLATASVIR-DIHYDROCHLORID; REG. NO/DATE: EU/1/14/939 20140822
2015006Lithuania► SubscribePRODUCT NAME: DACLATASVIRUM; REGISTRATION NO/DATE: EU/1/14/939/001 - EU/1/14/939/004 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
90007-9Sweden► SubscribePRODUCT NAME: DACLATASVIR AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, ESPECIALLY DACLATASVIR DIHYDROCHLORIDE; REG. NO/DATE: EU/1/14/939 20140826
00713Netherlands► SubscribePRODUCT NAME: DACLATASVIR EN FARMACEUTISCH; REGISTRATION NO/DATE: EU/1/14/939/001-004 20150119
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Express Scripts
Healthtrust
Deloitte
Fish and Richardson
Covington
Teva
Harvard Business School
Medtronic
Novartis
Farmers Insurance

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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