GENVOYA Drug Patent Profile
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Which patents cover Genvoya, and when can generic versions of Genvoya launch?
Genvoya is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.
This drug has five hundred and twenty-six patent family members in fifty-six countries.
The generic ingredient in GENVOYA is cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate profile page.
DrugPatentWatch® 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 April 6, 2033. This may change due to patent challenges or generic licensing.
There have been twenty-three 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: | 526 |
| US Patents: | 10 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 19 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for GENVOYA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for GENVOYA |
| What excipients (inactive ingredients) are in GENVOYA? | GENVOYA excipients list |
| DailyMed Link: | GENVOYA at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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 |
|---|---|
| Unity Health Toronto | Phase 2 |
| Canadian Institutes of Health Research (CIHR) | Phase 2 |
| St. Michael's Hospital, Toronto | Phase 2 |
Pharmacology for GENVOYA
Anatomical Therapeutic Chemical (ATC) Classes for GENVOYA
Paragraph IV (Patent) Challenges for GENVOYA
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| GENVOYA | Tablets | cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate | 150 mg/150 mg/ 200 mg/10 mg | 207561 | 1 | 2023-04-12 |
US Patents and Regulatory Information for GENVOYA
GENVOYA is protected by ten US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of GENVOYA is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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 GENVOYA
Use of solid carrier particles to improve the processability of a pharmaceutical agent
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
4-oxoquinoline compound and use thereof as pharmaceutical agent
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Prodrugs of phosphonate nucleotide analogues
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Stable crystal of 4-oxoquinoline compound
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Modulators of pharmacokinetic properties of therapeutics
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Combination therapy
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Tenofovir alafenamide hemifumarate
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Stable crystal of 4-oxoquinoline compound
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Tenofovir alafenamide hemifumarate
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Modulators of pharmacokinetic properties of therapeutics
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Gilead Sciences Inc | GENVOYA | cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 207561-001 | Nov 5, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Gilead Sciences Inc | GENVOYA | cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 207561-001 | Nov 5, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Gilead Sciences Inc | GENVOYA | cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 207561-001 | Nov 5, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Gilead Sciences Inc | GENVOYA | cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 207561-001 | Nov 5, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Gilead Sciences Inc | GENVOYA | cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 207561-001 | Nov 5, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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 | ⤷ Try a Trial | ⤷ Try a Trial |
| Gilead Sciences Inc | GENVOYA | cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 207561-001 | Nov 5, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| Gilead Sciences Inc | GENVOYA | cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 207561-001 | Nov 5, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| Gilead Sciences Inc | GENVOYA | cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 207561-001 | Nov 5, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| Gilead Sciences Inc | GENVOYA | cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 207561-001 | Nov 5, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for GENVOYA
When does loss-of-exclusivity occur for GENVOYA?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
African Regional IP Organization (ARIPO)
Patent: 89
Estimated Expiration: ⤷ Try a Trial
Patent: 50
Estimated Expiration: ⤷ Try a Trial
Argentina
Patent: 5369
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 09242451
Estimated Expiration: ⤷ Try a Trial
Patent: 10210598
Estimated Expiration: ⤷ Try a Trial
Patent: 14221210
Estimated Expiration: ⤷ Try a Trial
Patent: 15200637
Estimated Expiration: ⤷ Try a Trial
Patent: 16250470
Estimated Expiration: ⤷ Try a Trial
Patent: 17201473
Estimated Expiration: ⤷ Try a Trial
Patent: 18267573
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0911871
Estimated Expiration: ⤷ Try a Trial
Patent: 1008664
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 20856
Estimated Expiration: ⤷ Try a Trial
Patent: 50521
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 11001885
Estimated Expiration: ⤷ Try a Trial
China
Patent: 2123700
Estimated Expiration: ⤷ Try a Trial
Patent: 2307573
Estimated Expiration: ⤷ Try a Trial
Patent: 3479584
Estimated Expiration: ⤷ Try a Trial
Patent: 4940937
Estimated Expiration: ⤷ Try a Trial
Colombia
Patent: 21225
Estimated Expiration: ⤷ Try a Trial
Patent: 00187
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0151009
Estimated Expiration: ⤷ Try a Trial
Patent: 0151357
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 16852
Estimated Expiration: ⤷ Try a Trial
Patent: 17067
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 96633
Estimated Expiration: ⤷ Try a Trial
Patent: 93485
Estimated Expiration: ⤷ Try a Trial
Ecuador
Patent: 10010636
Estimated Expiration: ⤷ Try a Trial
Patent: 11011307
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 1313
Estimated Expiration: ⤷ Try a Trial
Patent: 2950
Estimated Expiration: ⤷ Try a Trial
Patent: 0123
Estimated Expiration: ⤷ Try a Trial
Patent: 1071173
Estimated Expiration: ⤷ Try a Trial
Patent: 1190125
Estimated Expiration: ⤷ Try a Trial
Patent: 1491658
Estimated Expiration: ⤷ Try a Trial
Patent: 1591353
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 96633
Estimated Expiration: ⤷ Try a Trial
Patent: 93485
Estimated Expiration: ⤷ Try a Trial
Patent: 06032
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 53670
Estimated Expiration: ⤷ Try a Trial
Patent: 64737
Estimated Expiration: ⤷ Try a Trial
Patent: 15679
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 25822
Estimated Expiration: ⤷ Try a Trial
Patent: 26380
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 8614
Estimated Expiration: ⤷ Try a Trial
Patent: 4227
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 11242
Estimated Expiration: ⤷ Try a Trial
Patent: 22213
Estimated Expiration: ⤷ Try a Trial
Patent: 11927
Estimated Expiration: ⤷ Try a Trial
Patent: 25171
Estimated Expiration: ⤷ Try a Trial
Patent: 11522790
Estimated Expiration: ⤷ Try a Trial
Patent: 12517432
Estimated Expiration: ⤷ Try a Trial
Patent: 14012741
Estimated Expiration: ⤷ Try a Trial
Patent: 14221845
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 2377
Estimated Expiration: ⤷ Try a Trial
Patent: 10011963
Estimated Expiration: ⤷ Try a Trial
Patent: 11008289
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 8978
Estimated Expiration: ⤷ Try a Trial
Patent: 4214
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 110994
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 96633
Estimated Expiration: ⤷ Try a Trial
Patent: 93485
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 96633
Estimated Expiration: ⤷ Try a Trial
Patent: 93485
Estimated Expiration: ⤷ Try a Trial
San Marino
Patent: 01500266
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 3544
Estimated Expiration: ⤷ Try a Trial
Patent: 0618
Estimated Expiration: ⤷ Try a Trial
Patent: 14007744
Estimated Expiration: ⤷ Try a Trial
Patent: 201609006W
Estimated Expiration: ⤷ Try a Trial
Patent: 201706215U
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 96633
Estimated Expiration: ⤷ Try a Trial
Patent: 93485
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1008007
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1645759
Estimated Expiration: ⤷ Try a Trial
Patent: 1659971
Estimated Expiration: ⤷ Try a Trial
Patent: 1738325
Estimated Expiration: ⤷ Try a Trial
Patent: 1784647
Estimated Expiration: ⤷ Try a Trial
Patent: 110015581
Estimated Expiration: ⤷ Try a Trial
Patent: 110122729
Estimated Expiration: ⤷ Try a Trial
Patent: 160093100
Estimated Expiration: ⤷ Try a Trial
Patent: 160114728
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 48886
Estimated Expiration: ⤷ Try a Trial
Patent: 53897
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 44367
Estimated Expiration: ⤷ Try a Trial
Patent: 1040142
Estimated Expiration: ⤷ Try a Trial
Ukraine
Patent: 1193
Estimated Expiration: ⤷ Try a Trial
Patent: 3224
Estimated Expiration: ⤷ Try a Trial
Uruguay
Patent: 424
Estimated Expiration: ⤷ Try a Trial
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 GENVOYA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Brazil | 112014003420 | hemifumarato de tenofovir alafenamida | ⤷ Try a Trial |
| Australia | 4474599 | ⤷ Try a Trial | |
| Canada | 2470365 | COMPOSES 4-OXOQUINOLINIQUES ET LEUR UTILISATION COMME INHIBITEUR DE LA VIH-INTEGRASE (4-OXOQUINOLINE COMPOUND AND USE THEREOF AS HIV INTEGRASE INHIBITOR) | ⤷ Try a Trial |
| European Patent Office | 4299563 | COMBINAISON COMPRENANT UN CRISTAL STABLE D'UN COMPOSÉ 4-OXOQUINOLINE (COMBINATION COMPRISING A STABLE CRYSTAL OF A 4-OXOQUINOLINE COMPOUND) | ⤷ Try a Trial |
| Norway | 20220690 | Stabil krystall av 4-oxoquinolinforbindelse | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for GENVOYA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2487166 | 2016C/065 | Belgium | ⤷ Try a Trial | PRODUCT NAME: COBICISTAT AND TENOFOVIR ALAFENAMIDE; AUTHORISATION NUMBER AND DATE: EU/1/15/1061 20151123 |
| 1564210 | CA 2013 00058 | Denmark | ⤷ Try a Trial | PRODUCT NAME: ELVITEGRAVIR I ENHVER FORM SOM ER OMFATTET AF GRUNDPATENTET; REG. NO/DATE: EU/1/13/830/001-002 20130524 |
| 2487162 | 2016/063 | Ireland | ⤷ Try a Trial | PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF AND DARUNAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, IN PARTICULAR DARUNAVIR ETHANOLATE; REGISTRATION NO/DATE: EU/1/14/967 20141119 |
| 3150586 | 18/2020 | Austria | ⤷ Try a Trial | PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON, DARUNAVIR ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON, INSBESONDERE DARUNAVIRETHANOLAT, UND EMTRICITABIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/17/1225 20170925 |
| 2487163 | SPC/GB17/010 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND ATAZANAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR ATAZANAVIR SULFATE; REGISTERED: UK EU/1/15/1025/001 20150715; UK EU/1/15/1025/002 20150715 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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