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Last Updated: December 9, 2019

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Elbasvir; grazoprevir - Generic Drug Details

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What are the generic drug sources for elbasvir; grazoprevir and what is the scope of freedom to operate?

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

Elbasvir; grazoprevir has one hundred and five patent family members in forty-three countries.

One supplier is listed for this compound.

Summary for elbasvir; grazoprevir
International Patents:105
US Patents:2
Tradenames:1
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Clinical Trials: 57
DailyMed Link:elbasvir; grazoprevir at DailyMed
Recent Clinical Trials for elbasvir; grazoprevir

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Sanjay Gandhi Postgraduate Institute of Medical SciencesPhase 3
Radboud UniversityPhase 1
Albert Einstein Healthcare NetworkPhase 4

See all elbasvir; grazoprevir clinical trials

US Patents and Regulatory Information for elbasvir; grazoprevir

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme ZEPATIER elbasvir; grazoprevir TABLET;ORAL 208261-001 Jan 28, 2016 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Merck Sharp Dohme ZEPATIER elbasvir; grazoprevir TABLET;ORAL 208261-001 Jan 28, 2016 RX Yes Yes   Start Trial   Start Trial   Start Trial
Merck Sharp Dohme ZEPATIER elbasvir; grazoprevir TABLET;ORAL 208261-001 Jan 28, 2016 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for elbasvir; grazoprevir

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2410844 122017000001 Germany   Start Trial PRODUCT NAME: ELBASVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/16/1119 20160722
2410844 C20160050 00207 Estonia   Start Trial PRODUCT NAME: ELBASVIIR;REG NO/DATE: EU/1/16/1119 26.07.2016
2310095 PA2016049,C2310095 Lithuania   Start Trial PRODUCT NAME: GRAZOPREVIRAS ARBA FARMACISKAI PRIIMTINOS JO DRUSKOS; NAT. REGISTRATION NO/DATE: CH/65861 01 20160401; FIRST REGISTRATION: EU/1/16/1119 20160722
2410844 PA2016048 Lithuania   Start Trial PRODUCT NAME: ELBASVIRAS ARBA JO FARMACISKAI PRIIMTINOS DRUSKOS; NAT. REGISTRATION NO/DATE: CH/65861 01 20160401; FIRST REGISTRATION: EU/1/16/1119 20160722
2310095 CA 2016 00070 Denmark   Start Trial PRODUCT NAME: GRAZOPREVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/16/1119 20160726
2410844 300858 Netherlands   Start Trial PRODUCT NAME: ELBASVIR DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/16/1119 20160726
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Harvard Business School
AstraZeneca
Merck
Dow
Moodys

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