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Last Updated: January 28, 2020

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MAVYRET Drug Profile

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When do Mavyret patents expire, and when can generic versions of Mavyret launch?

Mavyret is a drug marketed by Abbvie Inc and is included in one NDA. There are seven patents protecting this drug.

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

The generic ingredient in MAVYRET is glecaprevir; pibrentasvir. One supplier is listed for this compound. Additional details are available on the glecaprevir; pibrentasvir profile page.

US ANDA Litigation and Generic Entry Outlook for Mavyret

Mavyret will be eligible for patent challenges on August 3, 2021. 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 June 5, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for MAVYRET
International Patents:401
US Patents:7
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Clinical Trials: 5
Drug Prices: Drug price information for MAVYRET
DailyMed Link:MAVYRET at DailyMed
Drug patent expirations by year for MAVYRET
Drug Prices for MAVYRET

See drug prices for MAVYRET

Generic Entry Opportunity Date for MAVYRET
Generic Entry Date for MAVYRET*:
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 MAVYRET

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

SponsorPhase
University of MarylandEarly Phase 1
Raymond T. Chung, MDPhase 4
Massachusetts General HospitalPhase 4

See all MAVYRET clinical trials

US Patents and Regulatory Information for MAVYRET

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbvie Inc MAVYRET glecaprevir; pibrentasvir TABLET;ORAL 209394-001 Aug 3, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Abbvie Inc MAVYRET glecaprevir; pibrentasvir TABLET;ORAL 209394-001 Aug 3, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Abbvie Inc MAVYRET glecaprevir; pibrentasvir TABLET;ORAL 209394-001 Aug 3, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Abbvie Inc MAVYRET glecaprevir; pibrentasvir TABLET;ORAL 209394-001 Aug 3, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Abbvie Inc MAVYRET glecaprevir; pibrentasvir TABLET;ORAL 209394-001 Aug 3, 2017 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 MAVYRET

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2692346 122017000074 Germany   Start Trial PRODUCT NAME: PIBRENTASVIR ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1213 20170726
2368890 C20150016 00154 Estonia   Start Trial PRODUCT NAME: OMBITASVIIR;REG NO/DATE: EU/1/14/982 19.01.2015
2692346 C201730039 Spain   Start Trial PRODUCT NAME: PIBRENTASVIR O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/17/1213; DATE OF AUTHORISATION: 20170726; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1213; DATE OF FIRST AUTHORISATION IN EEA: 20170726
2618831 1790051-5 Sweden   Start Trial PRODUCT NAME: GLECAPREVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEREOF; REG. NO/DATE: EU/1/17/1213 20170728
2618831 C02618831/01 Switzerland   Start Trial PRODUCT NAME: GLECAPREVIR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66472 22.09.2017
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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