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ZEPATIER Drug Patent Profile

When do Zepatier patents expire, and what generic alternatives are available?

Zepatier is a drug marketed by Msd Sub Merck and is included in one NDA. There are two patents protecting this drug.

This drug has one hundred and twelve patent family members in forty-six countries.

The generic ingredient in ZEPATIER is elbasvir; grazoprevir. One supplier is listed for this compound. Additional details are available on the elbasvir; grazoprevir profile page.

DrugPatentWatch^® Generic Entry Outlook for Zepatier

Zepatier was eligible for patent challenges on January 28, 2020.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 4, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ZEPATIER

International Patents:	112
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	25
Patent Applications:	12
Drug Prices:	Drug price information for ZEPATIER
What excipients (inactive ingredients) are in ZEPATIER?	ZEPATIER excipients list
DailyMed Link:	ZEPATIER at DailyMed

See drug prices for ZEPATIER

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

NDA:

208261

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 ZEPATIER

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Pennsylvania	Phase 4
Radboud University	Phase 1
King's College Hospital NHS Trust	Phase 4

See all ZEPATIER clinical trials

Pharmacology for ZEPATIER

Drug Class	Hepatitis C Virus NS3/4A Protease Inhibitor Hepatitis C Virus NS5A Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 3A Inhibitors HCV NS3/4A Protease Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ZEPATIER

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

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

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 ZEPATIER

ZEPATIER is protected by two US patents and one FDA Regulatory Exclusivity.

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 ZEPATIER

FDA Regulatory Exclusivity protecting ZEPATIER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Msd Sub Merck	ZEPATIER	elbasvir; grazoprevir	TABLET;ORAL	208261-001	Jan 28, 2016		RX	Yes	Yes			Y	Y
Msd Sub Merck	ZEPATIER	elbasvir; grazoprevir	TABLET;ORAL	208261-001	Jan 28, 2016		RX	Yes	Yes			Y	Y
Msd Sub Merck	ZEPATIER	elbasvir; grazoprevir	TABLET;ORAL	208261-001	Jan 28, 2016		RX	Yes	Yes

EU/EMA Drug Approvals for ZEPATIER

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Merck Sharp & Dohme B.V.	Zepatier	elbasvir, grazoprevir	EMEA/H/C/004126 ZEPATIER is indicated for the treatment of chronic hepatitis C (CHC) in adult and paediatric patients 12 years of age and older who weigh at least 30 kg (see sections 4.2, 4.4 and 5.1).For hepatitis C virus (HCV) genotype-specific activity see sections 4.4 and 5.1.	Authorised	no	no	no	2016-07-22

International Patents for ZEPATIER

When does loss-of-exclusivity occur for ZEPATIER?

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

Australia

Brazil

Canada

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Dominican Republic

Ecuador

Eurasian Patent Organization

European Patent Office

France

Georgia, Republic of

Hong Kong

Hungary

Israel

Japan

Lithuania

Luxembourg

Malaysia

Mexico

Montenegro

Morocco

Netherlands

New Zealand

Nicaragua

Norway

Peru

Poland

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Tunisia

Ukraine

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 ZEPATIER around the world.

Country	Patent Number	Title	Estimated Expiration
Montenegro	02132	KOMBINACIJE MAKROCIKLIČNOG JEDINJENJA HINOKSALINA KOJE JE INHIBITOR HCV NS3 PROTEAZE SA DRUGIM HCV SREDSTVIMA (COMBINATIONS OF A MACROCYCLIC QUINOXALINE COMPOUND WHICH IS AN HCV NS3 PROTEASE INHIBITOR WITH OTHER HCV AGENTS)
Netherlands	300858
Cyprus	1113752
European Patent Office	2410844	INHIBITEURS DE LA RÉPLICATION DU VIRUS DE L'HÉPATITE C (INHIBITORS OF HEPATITIS C VIRUS REPLICATION)
China	103880862	Inhibitors Of Hepatitis C Virus Replication

Supplementary Protection Certificates for ZEPATIER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2310095	PA2016049	Lithuania		PRODUCT NAME: GRAZOPREVIRAS ARBA JO FARMACISKAI PRIIMTINOS DRUSKOS; NAT. REGISTRATION NO/DATE: CH/65861 01 20160401; FIRST REGISTRATION: EU/1/16/1119 20160722
2410844	CA 2016 00069	Denmark		PRODUCT NAME: ELBASVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/16/1119 20160726
2310095	2017004	Norway		PRODUCT NAME: GRAZOPREVIR ELLER ET; REG. NO/DATE: EU/1/16/1119 20160804
2310095	132017000002002	Italy		PRODUCT NAME: GRAZOPREVIR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(ZEPATIER); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1119, 20160726
2310095	2016C/078	Belgium		PRODUCT NAME: GRAZOPREVIR DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; AUTHORISATION NUMBER AND DATE: EU/1/16/1119 20160726