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 and is included in two NDAs. There are ten patents protecting this drug.
This drug has five hundred and thirty-four patent family members in forty-six 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: | 534 |
| 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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for MAVYRET
*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 |
Pharmacology for MAVYRET
US Patents and Regulatory Information for MAVYRET
MAVYRET is protected by ten US patents and five FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of MAVYRET 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 MAVYRET
Anti-viral compounds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Anti-viral compounds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Method for treating HCV
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Solid pharmaceutical compositions for treating HCV
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Macrocyclic proline derived HCV serine protease inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Anti-viral compounds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Crystal forms
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Anti-viral compounds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Crystal forms
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting MAVYRET
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: ⤷ Sign Up
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Sign Up
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: ⤷ Sign Up
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: ⤷ Sign Up
PEDIATRIC EXCLUSIVITY
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abbvie | MAVYRET | glecaprevir; pibrentasvir | PELLETS;ORAL | 215110-001 | Jun 10, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Abbvie | MAVYRET | glecaprevir; pibrentasvir | TABLET;ORAL | 209394-001 | Aug 3, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Abbvie | MAVYRET | glecaprevir; pibrentasvir | TABLET;ORAL | 209394-001 | Aug 3, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Abbvie | MAVYRET | glecaprevir; pibrentasvir | PELLETS;ORAL | 215110-001 | Jun 10, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Abbvie | MAVYRET | glecaprevir; pibrentasvir | PELLETS;ORAL | 215110-001 | Jun 10, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Abbvie | MAVYRET | glecaprevir; pibrentasvir | TABLET;ORAL | 209394-001 | Aug 3, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 MAVYRET
| 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
Patent: Crystal forms
Estimated Expiration: ⤷ Sign Up
Patent: 16283018
Patent: Solid pharmaceutical compositions for treating HCV
Estimated Expiration: ⤷ Sign Up
Patent: 16296709
Patent: Solid pharmaceutical compositions for treating HCV
Estimated Expiration: ⤷ Sign Up
Patent: 20239679
Patent: Crystal forms
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2017028185
Patent: composições farmacêuticas sólidas para tratar hcv
Estimated Expiration: ⤷ Sign Up
Patent: 2018000982
Patent: composições farmacêuticas sólidas para tratar hcv
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 48902
Patent: FORMES CRISTALLINES D'INHIBITEURS DE PROTEASE DU VIRUS DE L'HEPATITE C (VHC) ET LEUR UTILISATION (CRYSTAL FORMS OF HCV PROTEASE INHIBITORS AND USE THEREOF)
Estimated Expiration: ⤷ Sign Up
Patent: 90855
Patent: COMPOSITIONS PHARMACEUTIQUES SOLIDES POUR LE TRAITEMENT DU VHC (SOLID PHARMACEUTICAL COMPOSITIONS FOR TREATING HCV)
Estimated Expiration: ⤷ Sign Up
Patent: 92722
Patent: COMPOSITIONS PHARMACEUTIQUES SOLIDES POUR LE TRAITEMENT DU VHC (SOLID PHARMACEUTICAL COMPOSITIONS FOR TREATING HCV)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 17003350
Patent: Composiciones farmacéuticas sólidas para el tratamiento del vhc
Estimated Expiration: ⤷ Sign Up
Patent: 18000138
Patent: Composicion farmaceutica solida que comprende al compuesto 1 y al compuesto 2 en dispersiones solidas amorfas, y sus perfiles de disolucion.
Estimated Expiration: ⤷ Sign Up
China
Patent: 6413736
Patent: 晶型 (Crystal forms)
Estimated Expiration: ⤷ Sign Up
Patent: 7920996
Patent: 用于治疗HCV的固体药物组合物 (SOLID PHARMACEUTICAL COMPOSITIONS FOR TREATING HCV)
Estimated Expiration: ⤷ Sign Up
Patent: 8024964
Patent: 用于治疗HCV的固体药物组合物 (SOLID PHARMACEUTICAL COMPOSITIONS FOR TREATING HCV)
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 17013305
Patent: Composiciones farmacéuticas sólidas de dos capas para el tratamiento de vhc
Estimated Expiration: ⤷ Sign Up
Patent: 18000391
Patent: Composiciones farmacéuticas sólidas para el tratamiento del vhc
Estimated Expiration: ⤷ Sign Up
Costa Rica
Patent: 180030
Patent: COMPOSICIONES FARMACÉUTICAS SÓLIDAS PARA EL TRATAMIENTO DEL VHC.
Estimated Expiration: ⤷ Sign Up
Patent: 180088
Patent: COMPOSICIONES FARMACÉUTICAS SÓLIDAS PARA EL TRATAMIENTO DEL VHC
Estimated Expiration: ⤷ Sign Up
Dominican Republic
Patent: 017000314
Patent: COMPOSICIONES FARMACÉUTICAS SÓLIDAS PARA EL TRATAMIENTO DEL VHC
Estimated Expiration: ⤷ Sign Up
Patent: 018000024
Patent: COMPOSICIONES FARMACÉUTICAS SÓLIDAS PARA EL TRATAMIENTO DEL VHC
Estimated Expiration: ⤷ Sign Up
Ecuador
Patent: 18000689
Patent: COMPOSICIONES FARMACÉUTICAS SÓLIDAS PARA EL TRATAMIENTO DEL VHC
Estimated Expiration: ⤷ Sign Up
Patent: 18008411
Patent: COMPOSICIONES FARMACÉUTICAS SÓLIDAS PARA EL TRATAMIENTO DEL VHC
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 1890160
Patent: ТВЕРДЫЕ ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ДЛЯ ЛЕЧЕНИЯ ВИРУСА ГЕПАТИТА С
Estimated Expiration: ⤷ Sign Up
Patent: 1890334
Patent: ТВЕРДЫЕ ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ДЛЯ ЛЕЧЕНИЯ ВИРУСА ГЕПАТИТА С
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 51850
Patent: FORMES CRISTALLINES (CRYSTAL FORMS)
Estimated Expiration: ⤷ Sign Up
Patent: 13378
Patent: COMPOSITIONS PHARMACEUTIQUES SOLIDES POUR LE TRAITEMENT DU VHC (SOLID PHARMACEUTICAL COMPOSITIONS FOR TREATING HCV)
Estimated Expiration: ⤷ Sign Up
Patent: 24941
Patent: COMPOSITIONS PHARMACEUTIQUES SOLIDES POUR LE TRAITEMENT DU VHC (SOLID PHARMACEUTICAL COMPOSITIONS FOR TREATING HCV)
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 50627
Patent: 用於治療HCV的固體藥物組合物 (SOLID PHARMACEUTICAL COMPOSITIONS FOR TREATING HCV)
Estimated Expiration: ⤷ Sign Up
Patent: 55203
Patent: 用於治療HCV的固體藥物組合物 (SOLID PHARMACEUTICAL COMPOSITIONS FOR TREATING HCV)
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 6504
Patent: תכשירים רוקחיים מוצקים לטיפול ב- hcv (Solid pharmaceutical compositions for treating hcv)
Estimated Expiration: ⤷ Sign Up
Patent: 6945
Patent: תכשירים רוקחיים מוצקים לטיפול בנגיף ההפטיטיס c (Solid pharmaceutical compositions for treating hcv)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 33466
Estimated Expiration: ⤷ Sign Up
Patent: 62425
Estimated Expiration: ⤷ Sign Up
Patent: 17518319
Patent: 結晶形
Estimated Expiration: ⤷ Sign Up
Patent: 18518517
Patent: ＨＣＶを処置するための固体医薬組成物
Estimated Expiration: ⤷ Sign Up
Patent: 18520185
Patent: ＨＣＶを処置するための固体医薬組成物
Estimated Expiration: ⤷ Sign Up
Patent: 21113192
Patent: 結晶形 (CRYSTAL FORMS)
Estimated Expiration: ⤷ Sign Up
Patent: 22141719
Patent: ＨＣＶを処置するための固体医薬組成物
Estimated Expiration: ⤷ Sign Up
Patent: 22177014
Patent: ＨＣＶを処置するための固体医薬組成物
Estimated Expiration: ⤷ Sign Up
Patent: 23089125
Patent: 結晶形 (CRYSTAL FORMS)
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 2606
Patent: SOLID PHARMACEUTICAL COMPOSITIONS FOR TREATING HCV
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 16016127
Patent: FORMAS CRISTALINAS. (CRYSTAL FORMS.)
Estimated Expiration: ⤷ Sign Up
Patent: 18000218
Patent: COMPOSICIONES FARMACEUTICAS SOLIDAS PARA EL TRATAMIENTO DEL VHC. (SOLID PHARMACEUTICAL COMPOSITIONS FOR TREATING HCV.)
Estimated Expiration: ⤷ Sign Up
Patent: 18000746
Patent: COMPOSICIONES FARMACEUTICAS SOLIDAS PARA EL TRATAMIENTO DEL VHC. (SOLID PHARMACEUTICAL COMPOSITIONS FOR TREATING HCV.)
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 180488
Patent: COMPOSICIONES FARMACEUTICAS SOLIDAS PARA EL TRATAMIENTO DEL VHC
Estimated Expiration: ⤷ Sign Up
Patent: 180609
Patent: COMPOSICIONES FARMACEUTICAS SOLIDAS PARA EL TRATAMIENTO DEL VHC
Estimated Expiration: ⤷ Sign Up
Philippines
Patent: 017502426
Patent: SOLID PHARMACEUTICAL COMPOSITIONS FOR TREATING HCV
Estimated Expiration: ⤷ Sign Up
Patent: 018500132
Patent: SOLID PHARMACEUTICAL COMPOSITIONS FOR TREATING HCV
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 18102809
Patent: ТВЕРДЫЕ ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ДЛЯ ЛЕЧЕНИЯ ВИРУСА ГЕПАТИТА С
Estimated Expiration: ⤷ Sign Up
Patent: 18105849
Patent: ТВЕРДЫЕ ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ДЛЯ ЛЕЧЕНИЯ ВИРУСА ГЕПАТИТА С
Estimated Expiration: ⤷ Sign Up
Patent: 21102950
Patent: ТВЕРДЫЕ ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ДЛЯ ЛЕЧЕНИЯ ВИРУСА ГЕПАТИТА С
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 202002899V
Patent: SOLID PHARMACEUTICAL COMPOSITIONS FOR TREATING HCV
Estimated Expiration: ⤷ Sign Up
Patent: 202002900Y
Patent: SOLID PHARMACEUTICAL COMPOSITIONS FOR TREATING HCV
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1800533
Patent: SOLID PHARMACEUTICAL COMPOSITIONS FOR TREATING HCV
Estimated Expiration: ⤷ Sign Up
Patent: 1801082
Patent: SOLID PHARMACEUTICAL COMPOSITIONS FOR TREATING HCV
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 2637828
Estimated Expiration: ⤷ Sign Up
Patent: 180021840
Patent: HCV의 치료를 위한 고형 약제학적 조성물
Estimated Expiration: ⤷ Sign Up
Patent: 180025317
Patent: HCV의 치료를 위한 고형 약제학적 조성물
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 MAVYRET around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Eurasian Patent Organization | 201500728 | ИНГИБИТОРЫ HCV СЕРИНОВОЙ ПРОТЕАЗЫ, ПОЛУЧЕННЫЕ ИЗ МАКРОЦИКЛИЧЕСКОГО ПРОЛИНА | ⤷ Sign Up |
| Philippines | 12018500132 | SOLID PHARMACEUTICAL COMPOSITIONS FOR TREATING HCV | ⤷ Sign Up |
| Japan | 2017518319 | 結晶形 | ⤷ Sign Up |
| Japan | 2013539791 | ⤷ Sign Up | |
| Japan | 5911838 | ⤷ Sign Up | |
| European Patent Office | 2853531 | Composés antiviraux (Antiviral compounds) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for MAVYRET
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2618831 | 2017C/041 | Belgium | ⤷ Sign Up | PRODUCT NAME: GLECAPREVIR OU UN SEL OU ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/17/1213 20170728 |
| 2618831 | 300900 | Netherlands | ⤷ Sign Up | PRODUCT NAME: GLECAPREVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ESTER DAARVAN; REGISTRATION NO/DATE: EU/1/17/1213 20170728 |
| 2692346 | 1790050-7 | Sweden | ⤷ Sign Up | PRODUCT NAME: PIBRENTASVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/17/1213 20170728 |
| 2618831 | 2017056 | Norway | ⤷ Sign Up | PRODUCT NAME: GLEKAPREVIR ELLER ET; REG. NO/DATE: EU/1/17/1213 20170807 |
| 2368890 | 122015000039 | Germany | ⤷ Sign Up | PRODUCT NAME: OMBITASVIR; REGISTRATION NO/DATE: EU/1/14/982 20150115 |
| 2618831 | PA2017034 | Lithuania | ⤷ Sign Up | PRODUCT NAME: GLEKAPREVIRAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA ESTERIS; REGISTRATION NO/DATE: EU/1/17/1213 20170726 |
| >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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