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 thirteen 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
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Summary for ZEPATIER
| International Patents: | 113 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 25 |
| Drug Prices: | Drug price information for ZEPATIER |
| What excipients (inactive ingredients) are in ZEPATIER? | ZEPATIER excipients list |
| DailyMed Link: | ZEPATIER at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ZEPATIER
*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 |
Pharmacology for ZEPATIER
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 ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PATIENTS INFECTED WITH HEPATITIS C VIRUS
Inhibitors of hepatitis C virus replication
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PATIENTS INFECTED WITH HEPATITIS C VIRUS
FDA Regulatory Exclusivity protecting ZEPATIER
NEW PATIENT POPULATION
Exclusivity Expiration: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Msd Sub Merck | ZEPATIER | elbasvir; grazoprevir | TABLET;ORAL | 208261-001 | Jan 28, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Msd Sub Merck | ZEPATIER | elbasvir; grazoprevir | TABLET;ORAL | 208261-001 | Jan 28, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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
Patent: Inhibitors of hepatitis C virus replication
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 1013394
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 56172
Patent: INHIBITEURS DE LA REPLICATION DU VIRUS DE L'HEPATITE C (INHIBITORS OF HEPATITIS C VIRUS REPLICATION)
Estimated Expiration: ⤷ Sign Up
China
Patent: 2427729
Patent: Inhibitors of hepatitis c virus replication
Estimated Expiration: ⤷ Sign Up
Patent: 3880862
Patent: Inhibitors Of Hepatitis C Virus Replication
Estimated Expiration: ⤷ Sign Up
Patent: 9651342
Patent: 丙型肝炎病毒复制的抑制剂 (INHIBITORS OF HEPATITIS C VIRUS REPLICATION)
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 20390
Patent: INHIBIDORES DE LA REPLICACIÓN DEL VIRUS DE LA HEPATITIS C.
Estimated Expiration: ⤷ Sign Up
Costa Rica
Patent: 110506
Patent: INHIBIDORES DE LA REPLICACIÓN DEL VIRUS DE LA HEPATITIS C
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0160476
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 17644
Estimated Expiration: ⤷ Sign Up
Patent: 17004
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 10844
Estimated Expiration: ⤷ Sign Up
Dominican Republic
Patent: 011000298
Patent: METILO[(2S)-1-{(2S)-2-[5-(10-{2-[(2S)-1-{(2S)-2-[(METOXICARBONIL) AMINO]-3- METILBUTANOILO} PIRROLIDINA-2-YL]-1H-IMIDAZOL-5-YL}-6-FENILINDOL[1,2-C][1,3] BENZOXAZIN-3-YL)-1H-IMIDAZOL-2-YL]PIRROLIDINA-1-YL} -3-METILO-1-OXOBUTAN-2-YL]CARBAMATO Y USO DEL MISMO PARA TRATAR LA INFECCIÓN POR VHC
Estimated Expiration: ⤷ Sign Up
Ecuador
Patent: 11011357
Patent: INHIBIDORES DE LA REPLICACIÓN DEL VIRUS DE LA HEPATITIS C
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 0898
Patent: ИНГИБИТОРЫ РЕПЛИКАЦИИ ВИРУСА ГЕПАТИТА C (INHIBITORS OF HEPATITIS C VIRUS REPLICATION)
Estimated Expiration: ⤷ Sign Up
Patent: 1171174
Patent: ИНГИБИТОРЫ РЕПЛИКАЦИИ ВИРУСА ГЕПАТИТА C
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 10844
Patent: INHIBITEURS DE LA RÉPLICATION DU VIRUS DE L'HÉPATITE C (INHIBITORS OF HEPATITIS C VIRUS REPLICATION)
Estimated Expiration: ⤷ Sign Up
France
Patent: C1026
Estimated Expiration: ⤷ Sign Up
Georgia, Republic of
Patent: 0146134
Patent: INHIBITORS OF HEPATITIS C VIRUS REPLICATION
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 60359
Patent: 丙型肝炎病毒複製的抑制劑 (INHIBITORS OF HEPATITIS C VIRUS REPLICATION)
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 27755
Estimated Expiration: ⤷ Sign Up
Patent: 700002
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 5094
Patent: מתיל [1-{2-[5-(10-{2-[1-{2-[מתוקסיקרבוניל)אמינו]-3-מתילבוטאנוייל}פירולידינ-2-יל]-h1-אמידאזול-5-איל}-6-פנילאינדולו[2,1-c][3,1]בנזוקסאזינ-3-איל)-h 1-אמידאזול-2-איל] פירולידינ-1-יל}-3-מתיל-1-אוקסובוטאנ-2-איל]קרבמאט ותכשירי רוקחות לעיכוב hcv המכילים אותו (Methyl[1-{2-[5-(10-{2-[1-{2-[(methoxycarbonyl)amino]-3-methylbutanoyl}pyrrolidin-2-yl]-1h-imidazol-5-yl}-6-phenylindolo[1,2-c][1,3]benzoxazin-3-yl)-1h-imidazol-2-yl]pyrrolidin-1-yl}-3-methyl-1-oxobutan-2-yl]carbamate and pharmaceutical compositions for inhibiting hcv replication comprising it)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 13091
Estimated Expiration: ⤷ Sign Up
Patent: 32929
Estimated Expiration: ⤷ Sign Up
Patent: 12522000
Estimated Expiration: ⤷ Sign Up
Patent: 15028055
Patent: Ｃ型肝炎ウイルス複製の阻害剤 (INHIBITORS OF HEPATITIS C VIRUS REPLICATION)
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 410844
Estimated Expiration: ⤷ Sign Up
Patent: 2016048
Estimated Expiration: ⤷ Sign Up
Luxembourg
Patent: 0003
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 9311
Patent: INHIBITORS OF HEPATITIS C VIRUS REPLICATION
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 11010084
Patent: INHIBIDORES DE LA REPLICACION DEL VIRUS DE LA HEPATITIS C. (INHIBITORS OF HEPATITIS C VIRUS REPLICATION.)
Estimated Expiration: ⤷ Sign Up
Montenegro
Patent: 418
Patent: INHIBITORI REPLIKACIJE VIRUSA HEPATITISA C (INHIBITORS OF HEPATITIS C VIRUS REPLICATION)
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 209
Patent: مثبطات نسخ فيروس التهاب الكبد c
Estimated Expiration: ⤷ Sign Up
Netherlands
Patent: 0858
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 5410
Patent: Inhibitors of hepatitis c virus replication
Estimated Expiration: ⤷ Sign Up
Nicaragua
Patent: 1100172
Patent: INHIBIDORES DE LA REPLICACIÓN DEL VIRUS DE LA HEPATITIS C
Estimated Expiration: ⤷ Sign Up
Norway
Patent: 17006
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 120765
Patent: INHIBIDORES DE LA REPLICACION DEL VIRUS DE LA HEPATITIS C
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 10844
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 713
Patent: INHIBITORI REPLIKACIJE VIRUSA HEPATITISA C (INHIBITORS OF HEPATITIS C VIRUS REPLICATION)
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 4929
Patent: INHIBITORS OF HEPATITIS C VIRUS REPLICATION
Estimated Expiration: ⤷ Sign Up
Patent: 201402969Q
Patent: INHIBITORS OF HEPATITIS C VIRUS REPLICATION
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 10844
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1106807
Patent: INHIBITORS OF HEPATITIS C VIRUS REPLICATION
Estimated Expiration: ⤷ Sign Up
Patent: 1309504
Patent: INHIBITORS OF HEPATITIS C VIRUS REPLICATION
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1387274
Estimated Expiration: ⤷ Sign Up
Patent: 110130516
Patent: INHIBITORS OF HEPATITIS C VIRUS REPLICATION
Estimated Expiration: ⤷ Sign Up
Patent: 130140219
Patent: INHIBITORS OF HEPATITIS C VIRUS REPLICATION
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 73088
Estimated Expiration: ⤷ Sign Up
Tunisia
Patent: 11000475
Patent: INHIBITORS OF HEPATITIS C VIRUS REPLICATION
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 8351
Patent: ІНГІБІТОРИ РЕПЛІКАЦІЇ ВІРУСУ ГЕПАТИТУ C
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| Lithuania | PA2016048 | ⤷ Sign Up | |
| Singapore | 174929 | INHIBITORS OF HEPATITIS C VIRUS REPLICATION | ⤷ Sign Up |
| South Korea | 20130140219 | INHIBITORS OF HEPATITIS C VIRUS REPLICATION | ⤷ Sign Up |
| China | 103880862 | Inhibitors Of Hepatitis C Virus Replication | ⤷ Sign Up |
| Hong Kong | 1173402 | PHARMACEUTICAL COMPOSITIONS COMPRISING A MACROCYCLIC QUINOXALINE COMPOUND WHICH IS AN HCV NS3 PROTEASE INHIBITOR | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ZEPATIER
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2310095 | SPC/GB17/014 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: GRAZOPREVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTERED: UK EU/1/16/1119 20160726; UK PLGB 53092/0082 20160726 |
| 2310095 | C02310095/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: GRAZOPREVIR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65861 01.04.2016 |
| 2410844 | 2017006 | Norway | ⤷ Sign Up | PRODUCT NAME: ELBASVIR ELLER ET FARMASOEYTISK; REG. NO/DATE: EU/1/16/1119 20160804 |
| 2410844 | 680 | Finland | ⤷ Sign Up | |
| 2310095 | 2017004 | Norway | ⤷ Sign Up | PRODUCT NAME: GRAZOPREVIR ELLER ET; REG. NO/DATE: EU/1/16/1119 20160804 |
| >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.
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