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Last Updated: August 15, 2020

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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.

This drug has one hundred and eight patent family members in forty-four countries.

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.

US ANDA Litigation and Generic Entry Outlook for Zepatier

Zepatier was eligible for patent challenges on January 28, 2020.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 4, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for ZEPATIER
International Patents:108
US Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 1
Clinical Trials: 23
Drug Prices: Drug price information for ZEPATIER
DailyMed Link:ZEPATIER at DailyMed
Drug patent expirations by year for ZEPATIER
Drug Prices for ZEPATIER

See drug prices 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.

Recent Clinical Trials for ZEPATIER

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

SponsorPhase
Radboud UniversityPhase 1
DaVitaPhase 4
King's College Hospital NHS TrustPhase 4

See all ZEPATIER clinical trials

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   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 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
>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 ZEPATIER

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2410844 CR 2016 00069 Denmark   Start Trial PRODUCT NAME: ELBASVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/16/1119 20160726
2310095 2/2017 Austria   Start Trial PRODUCT NAME: GRAZOPREVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/16/1119 (MITTEILUNG) 20160726
2410844 132017000002014 Italy   Start Trial PRODUCT NAME: ELBASVIR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(ZEPATIER); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1119, 20160726
2410844 2017006 Norway   Start Trial PRODUCT NAME: ELBASVIR ELLER ET FARMASOEYTISK; REG. NO/DATE: EU/1/16/1119 20160804
2310095 132017000002002 Italy   Start Trial PRODUCT NAME: GRAZOPREVIR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(ZEPATIER); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1119, 20160726
2410844 2017/003 Ireland   Start Trial PRODUCT NAME: ELBASVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/16/1119 20160722
2410844 C02410844/01 Switzerland   Start Trial PRODUCT NAME: ELBASVIR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65861 01.04.2016
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Harvard Business School
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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 verification 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.