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Elbasvir; grazoprevir - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for elbasvir; grazoprevir?

Elbasvir; grazoprevir is the generic ingredient in one branded drug marketed by Merck Sharp Dohme and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Elbasvir; grazoprevir has eighty patent family members in thirty-eight countries.

One supplier is listed for this compound.

Summary for Generic Name: elbasvir; grazoprevir

Tradenames:1
Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Clinical Trials: see list25
Drug Prices:see low prices
DailyMed Link:elbasvir; grazoprevir at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme
ZEPATIER
elbasvir; grazoprevir
TABLET;ORAL208261-001Jan 28, 2016RXYesYes8,871,759► SubscribeYY ► Subscribe
Merck Sharp Dohme
ZEPATIER
elbasvir; grazoprevir
TABLET;ORAL208261-001Jan 28, 2016RXYesYes7,973,040► SubscribeYY ► Subscribe
Merck Sharp Dohme
ZEPATIER
elbasvir; grazoprevir
TABLET;ORAL208261-001Jan 28, 2016RXYesYes► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: elbasvir; grazoprevir

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
9,090,661Inhibitors of hepatitis C virus replication► Subscribe
8,080,654Macrocyclic quinoxaline compounds as HCV NS3 protease 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: elbasvir; grazoprevir

Country Document Number Estimated Expiration
Denmark2540350► Subscribe
Hong Kong1173403► Subscribe
Canada2756172► Subscribe
European Patent Office2310095► Subscribe
Japan4920797► 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: ELBASVIR; GRAZOPREVIR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0857Netherlands► SubscribePRODUCT NAME: GRAZOPREVIR DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/16/1119 20160726
2016048Lithuania► SubscribePRODUCT NAME: ELBASVIRAS ARBA JO FARMACISKAI PRIIMTINOS DRUSKOS; NAT. REGISTRATION NO/DATE: CH/65861 01 20160401; FIRST REGISTRATION: EU/1/16/1119 20160722
0858Netherlands► SubscribePRODUCT NAME: ELBASVIR DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/16/1119 20160726
2016 00070Denmark► SubscribePRODUCT NAME: GRAZOPREVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/16/1119 20160726
2016 00069Denmark► SubscribePRODUCT NAME: ELBASVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/16/1119 20160726
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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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