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MAVYRET Drug Profile
» See Plans and Pricing
Which patents cover Mavyret, and when can generic versions of Mavyret launch?
Mavyret is a drug marketed by Abbvie Inc and is included in one NDA. There are seven patents protecting this drug.
This drug has four hundred and eleven patent family members in forty-four 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.
US ANDA Litigation and Generic Entry Outlook for Mavyret
Mavyret will be eligible for patent challenges on August 3, 2021. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be June 5, 2035. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for MAVYRET
| International Patents: | 411 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 5 |
| Drug Prices: | Drug price information for MAVYRET |
| DailyMed Link: | MAVYRET at DailyMed |
Generic Entry Opportunity Date for MAVYRET
Generic Entry Date for MAVYRET*:
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 MAVYRET
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Maryland | Early Phase 1 |
| Massachusetts General Hospital | Phase 4 |
| Raymond T. Chung, MD | Phase 4 |
Pharmacology for MAVYRET
US Patents and Regulatory Information for 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 | Start Trial | Start Trial | Start Trial | ||||
| Abbvie Inc | MAVYRET | glecaprevir; pibrentasvir | TABLET;ORAL | 209394-001 | Aug 3, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Abbvie Inc | MAVYRET | glecaprevir; pibrentasvir | TABLET;ORAL | 209394-001 | Aug 3, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Abbvie Inc | MAVYRET | glecaprevir; pibrentasvir | TABLET;ORAL | 209394-001 | Aug 3, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Abbvie Inc | MAVYRET | glecaprevir; pibrentasvir | TABLET;ORAL | 209394-001 | Aug 3, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Abbvie Inc | MAVYRET | glecaprevir; pibrentasvir | TABLET;ORAL | 209394-001 | Aug 3, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Abbvie Inc | MAVYRET | glecaprevir; pibrentasvir | TABLET;ORAL | 209394-001 | Aug 3, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for MAVYRET
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| China | 104193729 | Start Trial |
| Dominican Republic | P2013000185 | Start Trial |
| European Patent Office | 3020723 | Start Trial |
| Israel | 233857 | Start Trial |
| Israel | 229248 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2012051361 | Start Trial |
| Hong Kong | 1184068 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for MAVYRET
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2618831 | 132017000122495 | Italy | Start Trial | PRODUCT NAME: GLECAPREVIR, O UN SUO SALE O ESTERE FARMACEUTICAMENTE ACCETTABILE(MAVIRET); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1213, 20170728 |
| 2368890 | 2015/010 | Ireland | Start Trial | PRODUCT NAME: OMBITASVIR, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/14/982 20150115 |
| 2692346 | CR 2017 00049 | Denmark | Start Trial | PRODUCT NAME: PIBRENTASVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/17/1213 20170728 |
| 2692346 | 300901 | Netherlands | Start Trial | PRODUCT NAME: PIBRENTASVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/17/1213 20170728 |
| 2368890 | PA2015012,C2368890 | Lithuania | Start Trial | PRODUCT NAME: OMBITASVIRAS; REGISTRATION NO/DATE: EU/1/14/982 20150115 |
| 2692346 | 17C1040 | France | Start Trial | PRODUCT NAME: PIBRENTASVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/17/1213 20170728 |
| 2618831 | C201730038 | Spain | Start Trial | PRODUCT NAME: GLECAPREVIR O UNA SAL O ESTER FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/17/1213; DATE OF AUTHORISATION: 20170726; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1213; DATE OF FIRST AUTHORISATION IN EEA: 20170726 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
