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Last Updated: January 22, 2020

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ZEPATIER Drug Profile

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Which patents cover Zepatier, and when can generic versions of Zepatier launch?

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 six patent family members in forty-three 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

  Start Trial

Zepatier will be eligible for patent challenges on January 28th, 2020. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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

Summary for ZEPATIER
International Patents:106
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
Hepatitis C TrustPhase 4
DaVitaPhase 4

See all ZEPATIER clinical trials

Synonyms for ZEPATIER
Elbasvir / grazoprevir
Elbasvir and grazoprevir
Elbasvir mixture with grazoprevir
S900006960

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 2017/003 Ireland   Start Trial PRODUCT NAME: ELBASVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/16/1119 20160722
2310095 CR 2016 00070 Denmark   Start Trial PRODUCT NAME: GRAZOPREVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/16/1119 20160726
2310095 2017004 Norway   Start Trial PRODUCT NAME: GRAZOPREVIR ELLER ET; REG. NO/DATE: EU/1/16/1119 20160804
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKesson
Mallinckrodt
Colorcon
Merck
Express Scripts
McKinsey

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