MAVYRET Drug Patent Profile

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

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

See drug prices for MAVYRET

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for MAVYRET

NDA:

209394

Dosage:

TABLET;ORAL

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
Duke University	Phase 4
NYU Langone Health	Early Phase 1
Mayo Clinic	Phase 4

See all MAVYRET clinical trials

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 nine US patents and thirteen FDA Regulatory Exclusivities.

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

FDA Regulatory Exclusivity protecting 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
Abbvie Inc	MAVYRET	glecaprevir; pibrentasvir	TABLET;ORAL	209394-001	Aug 3, 2017		RX	Yes	Yes
Abbvie Inc	MAVYRET	glecaprevir; pibrentasvir	TABLET;ORAL	209394-001	Aug 3, 2017		RX	Yes	Yes
Abbvie Inc	MAVYRET	glecaprevir; pibrentasvir	PELLETS;ORAL	215110-001	Jun 10, 2021		RX	Yes	Yes					Y
Abbvie Inc	MAVYRET	glecaprevir; pibrentasvir	TABLET;ORAL	209394-001	Aug 3, 2017		RX	Yes	Yes					Y

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

Brazil

Canada

Chile

China

Colombia

Costa Rica

Dominican Republic

Ecuador

Eurasian Patent Organization

European Patent Office

Hong Kong

Israel

Japan

Mexico

Peru

Philippines

Russian Federation

Singapore

South Africa

South Korea

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
Canada	2847910	COMPOSES ANTIVIRAUX (ANTI-VIRAL COMPOUNDS)
Canada	2948902	FORMES CRISTALLINES (CRYSTAL FORMS)
Poland	2579854
Slovenia	2368890

Supplementary Protection Certificates for MAVYRET

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