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Last Updated: September 25, 2022

ZEPATIER Drug Patent Profile


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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 ten patent family members in forty-five 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

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Summary for ZEPATIER
International Patents:110
US Patents:2
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 1
Clinical Trials: 25
Patent Applications: 21
Drug Prices: Drug price information for ZEPATIER
What excipients (inactive ingredients) are in ZEPATIER?ZEPATIER excipients list
DailyMed Link:ZEPATIER at DailyMed
Drug patent expirations by year for ZEPATIER
Drug Prices for ZEPATIER

See drug prices for ZEPATIER

DrugPatentWatch® Estimated Generic Entry Opportunity Date for ZEPATIER
Generic Entry Date for ZEPATIER*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
University of PennsylvaniaPhase 4
Radboud UniversityPhase 1
King's College Hospital NHS TrustPhase 4

See all ZEPATIER clinical trials

US Patents and Regulatory Information for ZEPATIER

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ZEPATIER 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 ZEPATIER

Macrocyclic quinoxaline compounds as HCV NS3 protease inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PATIENTS INFECTED WITH HEPATITIS C VIRUS

Inhibitors of hepatitis C virus replication
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PATIENTS INFECTED WITH HEPATITIS C VIRUS

FDA Regulatory Exclusivity protecting ZEPATIER

NEW PATIENT POPULATION
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
Msd Sub Merck ZEPATIER elbasvir; grazoprevir TABLET;ORAL 208261-001 Jan 28, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Msd Sub Merck ZEPATIER elbasvir; grazoprevir TABLET;ORAL 208261-001 Jan 28, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Msd Sub Merck ZEPATIER elbasvir; grazoprevir TABLET;ORAL 208261-001 Jan 28, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing 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

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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

Patent: 10229833
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 1013394
Estimated Expiration: See Plans and Pricing

Canada

Patent: 56172
Estimated Expiration: See Plans and Pricing

China

Patent: 2427729
Estimated Expiration: See Plans and Pricing

Patent: 3880862
Estimated Expiration: See Plans and Pricing

Patent: 9651342
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 20390
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 110506
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0160476
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 17644
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 10844
Estimated Expiration: See Plans and Pricing

Dominican Republic

Patent: 011000298
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 11011357
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 0898
Estimated Expiration: See Plans and Pricing

Patent: 1171174
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 10844
Estimated Expiration: See Plans and Pricing

Georgia, Republic of

Patent: 0146134
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 60359
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 27755
Estimated Expiration: See Plans and Pricing

Patent: 700002
Estimated Expiration: See Plans and Pricing

Israel

Patent: 5094
Estimated Expiration: See Plans and Pricing

Japan

Patent: 13091
Estimated Expiration: See Plans and Pricing

Patent: 32929
Estimated Expiration: See Plans and Pricing

Patent: 12522000
Estimated Expiration: See Plans and Pricing

Patent: 15028055
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 410844
Estimated Expiration: See Plans and Pricing

Patent: 2016048
Estimated Expiration: See Plans and Pricing

Luxembourg

Patent: 0003
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 9311
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 11010084
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 418
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 209
Estimated Expiration: See Plans and Pricing

Netherlands

Patent: 0858
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 5410
Estimated Expiration: See Plans and Pricing

Nicaragua

Patent: 1100172
Estimated Expiration: See Plans and Pricing

Norway

Patent: 17006
Estimated Expiration: See Plans and Pricing

Peru

Patent: 120765
Estimated Expiration: See Plans and Pricing

Poland

Patent: 10844
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 713
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 4929
Estimated Expiration: See Plans and Pricing

Patent: 201402969Q
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 10844
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1106807
Estimated Expiration: See Plans and Pricing

Patent: 1309504
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1387274
Estimated Expiration: See Plans and Pricing

Patent: 110130516
Estimated Expiration: See Plans and Pricing

Patent: 130140219
Estimated Expiration: See Plans and Pricing

Spain

Patent: 73088
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 11000475
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 8351
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 ZEPATIER around the world.

Country Patent Number Title Estimated Expiration
Peru 20120765 INHIBIDORES DE LA REPLICACION DEL VIRUS DE LA HEPATITIS C See Plans and Pricing
Serbia 53420 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) See Plans and Pricing
Japan 5932929 See Plans and Pricing
European Patent Office 2540349 COMPOSITIONS PHARMACEUTIQUES COMPRENANT UN COMPOSÉ DE QUINOXALINE MACROCYCLIQUE QUI EST UN INHIBITEUR DE LA PROTÉASE HCV NS3 (PHARMACEUTICAL COMPOSITIONS COMPRISING A MACROCYCLIC QUINOXALINE COMPOUND WHICH IS AN HCV NS3 PROTEASE INHIBITOR) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ZEPATIER

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2410844 CR 2016 00069 Denmark See Plans and Pricing PRODUCT NAME: ELBASVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/16/1119 20160726
2410844 2017/003 Ireland See Plans and Pricing PRODUCT NAME: ELBASVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/16/1119 20160722
2410844 C20160050 Estonia See Plans and Pricing (93) SZ 65861 01, 01.04.2016 (93) CH 65861 01, 01.04.2016
2410844 300858 Netherlands See Plans and Pricing PRODUCT NAME: ELBASVIR DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/16/1119 20160726
>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.