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Last Updated: April 13, 2024

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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 and is included in two NDAs. There are ten patents protecting this drug.

This drug has five hundred and thirty patent family members in forty-six 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:530
US Patents:10
Applicants:1
NDAs:2
Finished Product Suppliers / Packagers: 1
Clinical Trials: 29
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 Loss of Exclusivity (LOE) 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
White River Junction Veterans Affairs Medical CenterPhase 2
White River Junction Veterans Affairs Medical CenterPhase 2/Phase 3
Duke UniversityPhase 4

See all MAVYRET clinical trials

US Patents and Regulatory Information for MAVYRET

MAVYRET is protected by ten US patents and five FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of MAVYRET is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Anti-viral compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Method for treating HCV
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Solid pharmaceutical compositions for treating HCV
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Macrocyclic proline derived HCV serine protease inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Anti-viral compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Crystal forms
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Anti-viral compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Crystal forms
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

FDA Regulatory Exclusivity protecting MAVYRET

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: ⤷  Try a Trial

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Try a Trial

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: ⤷  Try a Trial

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: ⤷  Try a Trial

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Try a Trial

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

EU/EMA Drug Approvals for MAVYRET

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
AbbVie Deutschland GmbH Co. KG Maviret glecaprevir, pibrentasvir EMEA/H/C/004430
Maviret is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults and children aged 3 years and older.Maviret coated granules is indicated for the treatment of chronic hepatitis C virus (HCV) infection in children 3 years and older.
Authorised no no no 2017-07-26
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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: ⤷  Try a Trial

Patent: 16283018
Estimated Expiration: ⤷  Try a Trial

Patent: 16296709
Estimated Expiration: ⤷  Try a Trial

Patent: 20239679
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2017028185
Estimated Expiration: ⤷  Try a Trial

Patent: 2018000982
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 48902
Estimated Expiration: ⤷  Try a Trial

Patent: 90855
Estimated Expiration: ⤷  Try a Trial

Patent: 92722
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 17003350
Estimated Expiration: ⤷  Try a Trial

Patent: 18000138
Estimated Expiration: ⤷  Try a Trial

China

Patent: 6413736
Estimated Expiration: ⤷  Try a Trial

Patent: 7920996
Estimated Expiration: ⤷  Try a Trial

Patent: 8024964
Estimated Expiration: ⤷  Try a Trial

Colombia

Patent: 17013305
Estimated Expiration: ⤷  Try a Trial

Patent: 18000391
Estimated Expiration: ⤷  Try a Trial

Costa Rica

Patent: 180030
Estimated Expiration: ⤷  Try a Trial

Patent: 180088
Estimated Expiration: ⤷  Try a Trial

Dominican Republic

Patent: 017000314
Estimated Expiration: ⤷  Try a Trial

Patent: 018000024
Estimated Expiration: ⤷  Try a Trial

Ecuador

Patent: 18000689
Estimated Expiration: ⤷  Try a Trial

Patent: 18008411
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 1890160
Estimated Expiration: ⤷  Try a Trial

Patent: 1890334
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 51850
Estimated Expiration: ⤷  Try a Trial

Patent: 13378
Estimated Expiration: ⤷  Try a Trial

Patent: 24941
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 50627
Estimated Expiration: ⤷  Try a Trial

Patent: 55203
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 6504
Estimated Expiration: ⤷  Try a Trial

Patent: 6945
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 33466
Estimated Expiration: ⤷  Try a Trial

Patent: 62425
Estimated Expiration: ⤷  Try a Trial

Patent: 17518319
Estimated Expiration: ⤷  Try a Trial

Patent: 18518517
Estimated Expiration: ⤷  Try a Trial

Patent: 18520185
Estimated Expiration: ⤷  Try a Trial

Patent: 21113192
Estimated Expiration: ⤷  Try a Trial

Patent: 22141719
Estimated Expiration: ⤷  Try a Trial

Patent: 22177014
Estimated Expiration: ⤷  Try a Trial

Patent: 23089125
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 2606
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 16016127
Estimated Expiration: ⤷  Try a Trial

Patent: 18000218
Estimated Expiration: ⤷  Try a Trial

Patent: 18000746
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 180488
Estimated Expiration: ⤷  Try a Trial

Patent: 180609
Estimated Expiration: ⤷  Try a Trial

Philippines

Patent: 017502426
Estimated Expiration: ⤷  Try a Trial

Patent: 018500132
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 18102809
Estimated Expiration: ⤷  Try a Trial

Patent: 18105849
Estimated Expiration: ⤷  Try a Trial

Patent: 21102950
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 202002899V
Estimated Expiration: ⤷  Try a Trial

Patent: 202002900Y
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1800533
Estimated Expiration: ⤷  Try a Trial

Patent: 1801082
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 2637828
Estimated Expiration: ⤷  Try a Trial

Patent: 180021840
Estimated Expiration: ⤷  Try a Trial

Patent: 180025317
Estimated Expiration: ⤷  Try a Trial

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
Portugal 2954892 ⤷  Try a Trial
Taiwan I642436 ⤷  Try a Trial
New Zealand 591973 ANTI-VIRAL COMPOUNDS TO TREAT HCV INFECTION ⤷  Try a Trial
South Korea 20180025317 HCV의 치료를 위한 고형 약제학적 조성물 ⤷  Try a Trial
Eurasian Patent Organization 023009 ИНГИБИТОР HCV СЕРИНОВОЙ ПРОТЕАЗЫ, ПОЛУЧЕННЫЙ ИЗ МАКРОЦИКЛИЧЕСКОГО ПРОЛИНА, И ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, ПРЕДНАЗНАЧЕННАЯ ДЛЯ ЛЕЧЕНИЯ ВИРУСНОЙ ИНФЕКЦИИ (MACROCYCLIC PROLINE DERIVED HCV SERINE PROTEASE INHIBITOR AND PHARMACEUTICAL COMPOSITION FOR TREATING VIRUS INFECTION) ⤷  Try a Trial
Croatia P20150926 ⤷  Try a Trial
Japan 2021113192 結晶形 (CRYSTAL FORMS) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for MAVYRET

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2618831 SPC/GB17/057 United Kingdom ⤷  Try a Trial PRODUCT NAME: GLECAPREVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEREOF; REGISTERED: UK EU/1/17/1213 (NI) 20170728; UK FURTHER MAS ON IPSUM 20170728
2692346 LUC00038 Luxembourg ⤷  Try a Trial PRODUCT NAME: PIBRENTASVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/17/1213 20170728
2692346 300901 Netherlands ⤷  Try a Trial PRODUCT NAME: PIBRENTASVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/17/1213 20170728
2368890 207 50010-2015 Slovakia ⤷  Try a Trial PRODUCT NAME: OMBITASVIR; REGISTRATION NO/DATE: EU/1/14/982/001 20150119
2618831 PA2017034 Lithuania ⤷  Try a Trial PRODUCT NAME: GLEKAPREVIRAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA ESTERIS; REGISTRATION NO/DATE: EU/1/17/1213 20170726
2692346 122017000074 Germany ⤷  Try a Trial PRODUCT NAME: PIBRENTASVIR ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1213 20170726
2368890 33/2015 Austria ⤷  Try a Trial PRODUCT NAME: OMBITASVIR, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/982 (MITTEILUNG) 20150119
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.