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Last Updated: August 6, 2020

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MAVYRET Drug Profile

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Which patents cover Mavyret, 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 eleven 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:411
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
Massachusetts General HospitalPhase 4
Raymond T. Chung, MDPhase 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   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
Abbvie Inc MAVYRET glecaprevir; pibrentasvir TABLET;ORAL 209394-001 Aug 3, 2017 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 MAVYRET

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2618831 132017000122495 Italy   Start Trial PRODUCT NAME: GLECAPREVIR, O UN SUO SALE O ESTERE FARMACEUTICAMENTE ACCETTABILE(MAVIRET); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1213, 20170728
2368890 2015/010 Ireland   Start Trial PRODUCT NAME: OMBITASVIR, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/14/982 20150115
2692346 CR 2017 00049 Denmark   Start Trial PRODUCT NAME: PIBRENTASVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/17/1213 20170728
2692346 300901 Netherlands   Start Trial PRODUCT NAME: PIBRENTASVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/17/1213 20170728
2368890 PA2015012,C2368890 Lithuania   Start Trial PRODUCT NAME: OMBITASVIRAS; REGISTRATION NO/DATE: EU/1/14/982 20150115
2692346 17C1040 France   Start Trial PRODUCT NAME: PIBRENTASVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/17/1213 20170728
2618831 C201730038 Spain   Start Trial PRODUCT NAME: GLECAPREVIR O UNA SAL O ESTER 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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