DrugPatentWatch Database Preview
GENVOYA Drug 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 thirteen patents protecting this drug.
This drug has five hundred and forty-two patent family members in fifty-nine 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.
Summary for GENVOYA
| International Patents: | 542 |
| US Patents: | 13 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Clinical Trials: | 11 |
| 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
*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.
Pharmacology for GENVOYA
US Patents and Regulatory Information for GENVOYA
| 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 | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Gilead Sciences Inc | GENVOYA | cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 207561-001 | Nov 5, 2015 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Gilead Sciences Inc | GENVOYA | cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 207561-001 | Nov 5, 2015 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Gilead Sciences Inc | GENVOYA | cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 207561-001 | Nov 5, 2015 | 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 |
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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 | ➤ Sign Up | ➤ Sign Up |
| Gilead Sciences Inc | GENVOYA | cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 207561-001 | Nov 5, 2015 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Non-Orange Book US Patents for GENVOYA
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 5,728,575 | Method of resolution of 1,3-oxathiolane nucleoside enantiomers | ➤ Sign Up |
| 8,088,770 | Modulators of pharmacokinetic properties of therapeutics | ➤ Sign Up |
| 7,160,999 | Method of resolution and antiviral activity of 1,3-oxathiolane nucleoside enantiomers | ➤ Sign Up |
| 6,346,627 | Intermediates in the synthesis of 1,3-oxathiolane nucleoside enantiomers | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for GENVOYA
Supplementary Protection Certificates for GENVOYA
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2016000024 | Germany | ➤ Sign Up | PRODUCT NAME: TENOFOVIRALAFENAMID ODER EIN SALZ ODER SOLVAT DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/15/1061 20151119 |
| 2016038 | Lithuania | ➤ Sign Up | PRODUCT NAME: ELVITEGRAVIRAS + KOBICISTATAS + EMTRICITABINAS + TENOFOVIRALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/15/1061 20151119 |
| /2016 | Austria | ➤ Sign Up | PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON UND ATAZANAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE ATAZANAVIR-SULFAT; REGISTRATION NO/DATE: EU/1/15/1025 (MITTEILUNG) 20150715 |
| 2016 00012 | Denmark | ➤ Sign Up | PRODUCT NAME: TENOFOVIRALAFENAMID ELLER ET SALT ELLER SOLVAT DERAF, I SAERDELESHED TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/15/1061/001-002 20151123 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
