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DAKLINZA Drug Profile

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

This drug has sixty-two patent family members in twenty-six 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

Patents:5
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Drug Prices: :see details
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol-myers Squibb
DAKLINZA
daclatasvir dihydrochloride
TABLET;ORAL206843-001Jul 24, 2015RXNo8,642,025► subscribeYY ► subscribe
Bristol-myers Squibb
DAKLINZA
daclatasvir dihydrochloride
TABLET;ORAL206843-002Jul 24, 2015RXYes8,629,171► subscribeYY ► subscribe
Bristol-myers Squibb
DAKLINZA
daclatasvir dihydrochloride
TABLET;ORAL206843-001Jul 24, 2015RXNo8,329,159► subscribeY ► 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
8,846,023Hepatitis 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
Japan2010500413► subscribe
Israel196813► subscribe
Spain2402791► 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
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
2015Austria► subscribePRODUCT NAME: DECLATASVIR; REGISTRATION NO/DATE: EU/1/14/939 (MITTEILUNG) 20140826
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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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