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 ten patents protecting this drug.

This drug has five hundred and twenty-five 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:	525
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for MAVYRET

Generic Entry Dates for MAVYRET^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial NDA: 209394 Dosage: TABLET;ORAL
Generic Entry Dates for MAVYRET^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial NDA: 215110 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

Sponsor	Phase
White River Junction Veterans Affairs Medical Center	Phase 2
White River Junction Veterans Affairs Medical Center	Phase 2/Phase 3
Duke University	Phase 4

See all MAVYRET clinical trials

Pharmacology for MAVYRET

Drug Class	Hepatitis C Virus NS3/4A Protease Inhibitor Hepatitis C Virus NS5A Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 1A2 Inhibitors Cytochrome P450 3A Inhibitors HCV NS3/4A Protease Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors P-Glycoprotein Inhibitors UGT1A1 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for MAVYRET

J05AP	Antivirals for treatment of HCV infections
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for MAVYRET

MAVYRET is protected by ten US patents and thirteen 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

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

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial

INFORMATION ADDED TO THE LABELING REGARDING SAFETY AND EFFICACY IN SUBJECTS WITH HCV SUBTYPE 3B INFECTION
Exclusivity Expiration: ⤷ Try a Trial

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: ⤷ Try a Trial

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

NEW PATIENT POPULATION
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

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Glossary

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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	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Abbvie Inc	MAVYRET	glecaprevir; pibrentasvir	TABLET;ORAL	209394-001	Aug 3, 2017		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Abbvie Inc	MAVYRET	glecaprevir; pibrentasvir	TABLET;ORAL	209394-001	Aug 3, 2017		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Abbvie Inc	MAVYRET	glecaprevir; pibrentasvir	TABLET;ORAL	209394-001	Aug 3, 2017		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Abbvie Inc	MAVYRET	glecaprevir; pibrentasvir	PELLETS;ORAL	215110-001	Jun 10, 2021		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Abbvie Inc	MAVYRET	glecaprevir; pibrentasvir	TABLET;ORAL	209394-001	Aug 3, 2017		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Abbvie Inc	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

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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

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: 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.

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Country	Patent Number	Title	Estimated Expiration
Japan	2016104756	大環式プロリン由来ＨＣＶセリンプロテアーゼ阻害剤 (MACROCYCLIC PROLINE DERIVED HCV SERINE PROTEASE INHIBITORS)	⤷ Try a Trial
South Korea	20140037974	ANTI-VIRAL COMPOUNDS TO TREAT HCV INFECTION	⤷ Try a Trial
Poland	2455376		⤷ Try a Trial
Japan	2014510063		⤷ Try a Trial
Croatia	P20150926		⤷ Try a Trial
Japan	2021050223	ＨＣＶを処置するための方法 (METHODS FOR TREATING HCV)	⤷ Try a Trial
Mexico	2016012799	METODOS PARA TRATAR EL VIRUS DE LA HEPATITIS C. (METHODS FOR TREATING HCV.)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for MAVYRET

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2692346	122017000074	Germany	⤷ Try a Trial	PRODUCT NAME: PIBRENTASVIR ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1213 20170726
2368890	CR 2015 00015	Denmark	⤷ Try a Trial	PRODUCT NAME: OMBITASVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF; REG. NO/DATE: EU/1/14/982 20150119
2618831	132017000122495	Italy	⤷ Try a 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	15C0016	France	⤷ Try a Trial	PRODUCT NAME: OMBITASVIR DANS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/14/982 20150119
2618831	C02618831/01	Switzerland	⤷ Try a Trial	PRODUCT NAME: GLECAPREVIR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66472 22.09.2017
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
2368890	92668	Luxembourg	⤷ Try a Trial	PRODUCT NAME: OMBITASVIR, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE (VIEKIRAX R); FIRST REGISTRATION DATE: 20150119
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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MAVYRET Drug Patent Profile

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

DrugPatentWatch^® Generic Entry Outlook for Mavyret

Indicators of Generic Entry

Summary for MAVYRET

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for MAVYRET

Recent Clinical Trials for MAVYRET

Pharmacology for MAVYRET

Anatomical Therapeutic Chemical (ATC) Classes for MAVYRET

US Patents and Regulatory Information for MAVYRET

Patents protecting MAVYRET

FDA Regulatory Exclusivity protecting MAVYRET

EU/EMA Drug Approvals for MAVYRET

International Patents for MAVYRET

When does loss-of-exclusivity occur for MAVYRET?

Supplementary Protection Certificates for MAVYRET

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

Indicators of Generic Entry

Summary for MAVYRET

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for MAVYRET

Recent Clinical Trials for MAVYRET

Pharmacology for MAVYRET

Anatomical Therapeutic Chemical (ATC) Classes for MAVYRET

Patents protecting MAVYRET

FDA Regulatory Exclusivity protecting MAVYRET

When does loss-of-exclusivity occur for MAVYRET?

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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for MAVYRET