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Fish and Richardson
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Chinese Patent Office
Daiichi Sankyo
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Generated: October 15, 2018

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ZEPATIER Drug Profile

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When do Zepatier patents expire, and what generic alternatives are available?

Zepatier is a drug marketed by Merck Sharp Dohme and is included in one NDA. There are two patents protecting this drug.

The generic ingredient in ZEPATIER is elbasvir; grazoprevir. One supplier is listed for this compound. Additional details are available on the elbasvir; grazoprevir profile page.

Drug patent expirations by year for ZEPATIER
Generic Entry Opportunity Date for ZEPATIER
Generic Entry Date for ZEPATIER*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for ZEPATIER

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

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Supplementary Protection Certificates for ZEPATIER

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2016049 Lithuania ➤ Sign Up PRODUCT NAME: GRAZOPREVIRAS ARBA JO FARMACISKAI PRIIMTINOS DRUSKOS; NAT. REGISTRATION NO/DATE: CH/65861 01 20160401; FIRST REGISTRATION: EU/1/16/1119 20160722
90067-2 Sweden ➤ Sign Up PRODUCT NAME: ELBASVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT TH EREOF; REG. NO/DATE: EU/1/16/1119 20160726
C1026 France ➤ Sign Up PRODUCT NAME: ELBASVIR OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/16/1119 20160726
0160050 Estonia ➤ Sign Up (93) SZ 65861 01, 01.04.2016 (93) CH 65861 01, 01.04.2016
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Argus Health
McKinsey
Johnson and Johnson
Dow
Chinese Patent Office
Daiichi Sankyo
Fuji
Mallinckrodt

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