DrugPatentWatch Database Preview
MAVYRET Drug Profile
When do Mavyret patents expire, 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 one 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: | 401 |
| 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 |
| Raymond T. Chung, MD | Phase 4 |
| Massachusetts General Hospital | 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 | Y | Y | 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 |
|---|---|---|
| South Africa | 201302317 | Start Trial |
| Spain | 2624246 | Start Trial |
| European Patent Office | 3438106 | Start Trial |
| Guatemala | 201300093A | Start Trial |
| Canada | 2807847 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for MAVYRET
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2692346 | 122017000074 | Germany | Start Trial | PRODUCT NAME: PIBRENTASVIR ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1213 20170726 |
| 2368890 | C20150016 00154 | Estonia | Start Trial | PRODUCT NAME: OMBITASVIIR;REG NO/DATE: EU/1/14/982 19.01.2015 |
| 2692346 | C201730039 | Spain | Start Trial | PRODUCT NAME: PIBRENTASVIR O UNA SAL 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 |
| 2618831 | 1790051-5 | Sweden | Start Trial | PRODUCT NAME: GLECAPREVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEREOF; REG. NO/DATE: EU/1/17/1213 20170728 |
| 2618831 | C02618831/01 | Switzerland | Start Trial | PRODUCT NAME: GLECAPREVIR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66472 22.09.2017 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
