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Last Updated: May 26, 2022

MAVYRET Drug Patent 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 two NDAs. There are nine patents protecting this drug.

This drug has five hundred and fourteen patent family members in forty-five 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.

DrugPatentWatch® Generic Entry Outlook for Mavyret

Mavyret was eligible for patent challenges on August 3, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 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:514
US Patents:9
Applicants:1
NDAs:2
Finished Product Suppliers / Packagers: 1
Clinical Trials: 27
Drug Prices: Drug price information for MAVYRET
What excipients (inactive ingredients) are in MAVYRET?MAVYRET excipients list
DailyMed Link:MAVYRET at DailyMed
Drug patent expirations by year for MAVYRET
Drug Prices for MAVYRET

See drug prices for MAVYRET

DrugPatentWatch® Estimated Generic Entry Opportunity Date for MAVYRET
Generic Entry Dates for MAVYRET*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL
Generic Entry Dates for MAVYRET*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
PELLETS;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
Duke UniversityPhase 4
NYU Langone HealthEarly Phase 1
Mayo ClinicPhase 4

See all MAVYRET clinical trials

US Patents and Regulatory Information for MAVYRET

MAVYRET is protected by nine US patents and thirteen FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of MAVYRET is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting MAVYRET

Anti-viral compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Anti-viral compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Method for treating HCV
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Solid pharmaceutical compositions for treating HCV
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Macrocyclic proline derived HCV serine protease inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Anti-viral compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Crystal forms
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Anti-viral compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Crystal forms
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting MAVYRET

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

INFORMATION ADDED TO THE LABELING REGARDING SAFETY AND EFFICACY IN SUBJECTS WITH HCV SUBTYPE 3B INFECTION
Exclusivity Expiration: See Plans and Pricing

EIGHT-WEEK DOSING REGIMEN FOR THE TREATMENT OF GENOTYPES 1, 2, 3, 4, 5, AND 6, CHRONIC HEPATITIS C VIRUS INFECTION IN TREATMENT-NAIVE SUBJECTS WITH COMPENSATED CIRRHOSIS BASED ON THE RESULTS FROM THE EXPEDITION-8 STUDY
Exclusivity Expiration: See Plans and Pricing

FOR TREATMENT OF PEDIATRIC PATIENTS 3 YEARS OF AGE TO LESS THAN 12 YEARS OF AGE WEIGHING LESS THAN 45 KG WITH CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5 OR 6 INFECTION WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS (CHILD-PUGH A); AND TREATMENT OF PEDIATRIC PATIENTS 3 YEARS OF AGE TO LESS THAN 12 YEARS OF AGE WEIGHING LESS THAN 45 KG WITH HCV GENOTYPE 1 INFECTION, WHO PREVIOUSLY HAVE BEEN TREATED WITH A REGIMEN CONTAINING AN HCV NS5A INHIBITOR OR AN NS3/4A PROTEASE INHIBITOR (PI), BUT NOT BOTH
Exclusivity Expiration: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

NEW PATIENT POPULATION
Exclusivity Expiration: See Plans and Pricing

TREATMENT OF PEDIATRIC PATIENTS 12 YEARS AND OLDER OR WEIGHING AT LEAST 45 KG WITH CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1,2,3,4,5 OR 6 INFECTION WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS (CHILD-PUGH A)
Exclusivity Expiration: See Plans and Pricing

TREATMENT OF PEDIATRIC PATIENTS 12 YEARS AND OLDER OR WEIGHING AT LEAST 45 KG WITH HCV GENOTYPE 1 INFECTION, WHO PREVIOUSLY HAVE BEEN TREATED WITH A REGIMEN CONTAINING AN HCV NS5A INHIBITOR OR AN NS3/4A PROTEASE INHIBITOR (PI), BUT NOT BOTH
Exclusivity Expiration: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Abbvie Inc MAVYRET glecaprevir; pibrentasvir TABLET;ORAL 209394-001 Aug 3, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Abbvie Inc MAVYRET glecaprevir; pibrentasvir TABLET;ORAL 209394-001 Aug 3, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Abbvie Inc MAVYRET glecaprevir; pibrentasvir PELLETS;ORAL 215110-001 Jun 10, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Abbvie Inc MAVYRET glecaprevir; pibrentasvir TABLET;ORAL 209394-001 Aug 3, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for MAVYRET

When does loss-of-exclusivity occur for MAVYRET?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 15269306
Estimated Expiration: See Plans and Pricing

Patent: 16283018
Estimated Expiration: See Plans and Pricing

Patent: 16296709
Estimated Expiration: See Plans and Pricing

Patent: 20239679
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2017028185
Estimated Expiration: See Plans and Pricing

Patent: 2018000982
Estimated Expiration: See Plans and Pricing

Canada

Patent: 48902
Estimated Expiration: See Plans and Pricing

Patent: 90855
Estimated Expiration: See Plans and Pricing

Patent: 92722
Estimated Expiration: See Plans and Pricing

Chile

Patent: 17003350
Estimated Expiration: See Plans and Pricing

Patent: 18000138
Estimated Expiration: See Plans and Pricing

China

Patent: 6413736
Estimated Expiration: See Plans and Pricing

Patent: 7920996
Estimated Expiration: See Plans and Pricing

Patent: 8024964
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 17013305
Estimated Expiration: See Plans and Pricing

Patent: 18000391
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 180030
Estimated Expiration: See Plans and Pricing

Patent: 180088
Estimated Expiration: See Plans and Pricing

Dominican Republic

Patent: 017000314
Estimated Expiration: See Plans and Pricing

Patent: 018000024
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 18000689
Estimated Expiration: See Plans and Pricing

Patent: 18008411
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 1890160
Estimated Expiration: See Plans and Pricing

Patent: 1890334
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 51850
Estimated Expiration: See Plans and Pricing

Patent: 13378
Estimated Expiration: See Plans and Pricing

Patent: 24941
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 50627
Estimated Expiration: See Plans and Pricing

Patent: 55203
Estimated Expiration: See Plans and Pricing

Israel

Patent: 6504
Estimated Expiration: See Plans and Pricing

Patent: 6945
Estimated Expiration: See Plans and Pricing

Japan

Patent: 17518319
Estimated Expiration: See Plans and Pricing

Patent: 18518517
Estimated Expiration: See Plans and Pricing

Patent: 18520185
Estimated Expiration: See Plans and Pricing

Patent: 21113192
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 16016127
Estimated Expiration: See Plans and Pricing

Patent: 18000218
Estimated Expiration: See Plans and Pricing

Patent: 18000746
Estimated Expiration: See Plans and Pricing

Peru

Patent: 180488
Estimated Expiration: See Plans and Pricing

Patent: 180609
Estimated Expiration: See Plans and Pricing

Philippines

Patent: 017502426
Estimated Expiration: See Plans and Pricing

Patent: 018500132
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 18102809
Estimated Expiration: See Plans and Pricing

Patent: 18105849
Estimated Expiration: See Plans and Pricing

Patent: 21102950
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 202002899V
Estimated Expiration: See Plans and Pricing

Patent: 202002900Y
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1800533
Estimated Expiration: See Plans and Pricing

Patent: 1801082
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 180021840
Estimated Expiration: See Plans and Pricing

Patent: 180025317
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering MAVYRET around the world.

Country Patent Number Title Estimated Expiration
Slovenia 2455376 See Plans and Pricing
Canada 2847910 COMPOSES ANTIVIRAUX (ANTI-VIRAL COMPOUNDS) See Plans and Pricing
Canada 2948902 FORMES CRISTALLINES (CRYSTAL FORMS) See Plans and Pricing
Poland 2579854 See Plans and Pricing
Slovenia 2368890 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for MAVYRET

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2368890 33/2015 Austria See Plans and Pricing PRODUCT NAME: OMBITASVIR, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/982 (MITTEILUNG) 20150119
2692346 CR 2017 00049 Denmark See Plans and Pricing PRODUCT NAME: PIBRENTASVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/17/1213 20170728
2692346 51/2017 Austria See Plans and Pricing PRODUCT NAME: PIBRENTASVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1213 (MITTEILUNG) 20170728
2368890 15C0016 France See Plans and Pricing PRODUCT NAME: OMBITASVIR DANS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/14/982 20150119
2368890 2015012 Norway See Plans and Pricing PRODUCT NAME: OMBITASVIR, ELLER ET; REG. NO/DATE: EU/1/14/982 20150120
>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:

Johnson and Johnson
Mallinckrodt
Moodys
McKesson
Merck
Colorcon

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.