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Daclatasvir dihydrochloride - Generic Drug Details

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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.

This ingredient has sixty-two patent family members in twenty-six 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 / Packaging: see list1
Drug Prices:see low prices
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;ORAL206843-001Jul 24, 2015RXNo► subscribe► subscribe
Bristol-myers Squibb
DAKLINZA
daclatasvir dihydrochloride
TABLET;ORAL206843-002Jul 24, 2015RXYes8,629,171► 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
8,846,023Hepatitis C virus inhibitors► subscribe
9,227,961Hepatitis C virus inhibitors► subscribe
8,303,944Hepatitis 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
Japan5235882► subscribe
TaiwanI432426► subscribe
Canada2695729► 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
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
90007-9Sweden► subscribePRODUCT NAME: DACLATASVIR AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, ESPECIALLY DACLATASVIR DIHYDROCHLORIDE; REG. NO/DATE: EU/1/14/939 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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