DrugPatentWatch Database Preview
GENVOYA Drug Profile
» See Plans and Pricing
Which patents cover Genvoya, and what generic alternatives are available?
Genvoya is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are thirteen patents protecting this drug.
This drug has six hundred and sixty-four patent family members in sixty countries.
The generic ingredient in GENVOYA is cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate profile page.
US ANDA Litigation and Generic Entry Outlook for Genvoya
Genvoya was eligible for patent challenges on November 5, 2019.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be October 4, 2032. This may change due to patent challenges or generic licensing.
There have been seventeen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for GENVOYA
| International Patents: | 664 |
| US Patents: | 13 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Clinical Trials: | 20 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for GENVOYA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for GENVOYA |
| DailyMed Link: | GENVOYA at DailyMed |
Generic Entry Opportunity Date for GENVOYA
Generic Entry Date for GENVOYA*:
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 GENVOYA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Henry M. Jackson Foundation for the Advancement of Military Medicine | N/A |
| Johns Hopkins University | Phase 4 |
| Canadian Institutes of Health Research (CIHR) | Phase 2 |
Pharmacology for GENVOYA
US Patents and Regulatory Information for GENVOYA
Expired US Patents for GENVOYA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Gilead Sciences Inc | GENVOYA | cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 207561-001 | Nov 5, 2015 | Start Trial | Start Trial |
| Gilead Sciences Inc | GENVOYA | cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 207561-001 | Nov 5, 2015 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for GENVOYA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Hong Kong | 1143144 | Start Trial |
| South Korea | 20080064909 | Start Trial |
| Hong Kong | 1054238 | Start Trial |
| South Korea | 20090122261 | Start Trial |
| Norway | 20083728 | Start Trial |
| Japan | 2016169228 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for GENVOYA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1564210 | 92307 | Luxembourg | Start Trial | PRODUCT NAME: ELVIEGRAVIR SOUS TOUTES SES FORMES COMME PROTEGEES PAR LE BREVET DE BASE |
| 0513200 | 122004000015 | Germany | Start Trial | PRODUCT NAME: EMTRIVA-EMTRICITABINE; REGISTRATION NO/DATE: EU/1/03/261/001-003 20031024 |
| 1564210 | 13C0061 | France | Start Trial | PRODUCT NAME: ELVITEGRAVIR OU UN HYDRATE, SOLVATE, TAUTOMERE, OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CEUX-CI; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130524 |
| 1301519 | C 2016 011 | Romania | Start Trial | PRODUCT NAME: TENOFOVIR ALAFENAMIDA SAU O SARE SAU SOLVAT AL ACESTUIA, IN SPECIAL FUMARAT DE TENOFOVIR ALAFENAMIDA; NATIONAL AUTHORISATION NUMBER: EU/1/15/1061/001-002; DATE OF NATIONAL AUTHORISATION: 20151119; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1061/001-002; DATE OF FIRST AUTHORISATION IN EEA: 20151119 |
| 2487163 | 122016000120 | Germany | Start Trial | PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCHES AKZEPTABLES SALZ DAVON UND ATAZANAVIR ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE ATAZANAVIRSULFAT; REGISTRATION NO/DATE: EU/1/15/1025 20150713 |
| 2487162 | 132017000002735 | Italy | Start Trial | PRODUCT NAME: COBICISTAT O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE O UN SOLVATO DELLO STESSO E DARUNAVIR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE O UN SOLVATO DELLO STESSO, IN PARTICOLARE DARUNAVIR ETANOLATO(REZOLSTA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/967, 20141121 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
