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Generated: June 26, 2017
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 twelve patents protecting this drug.| Patents: | 12 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 2 |
| Clinical Trials: see list | 10 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | GENVOYA at DailyMed |
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| 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 | 5,814,639*PED | ► Subscribe | ||||||||||||||||||||||
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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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6,153,751 | Method and compositions for the synthesis of BCH-189 and related compounds | ► Subscribe | |||||||||||||||||||||||||||
| 6,346,627 | Intermediates in the synthesis of 1,3-oxathiolane nucleoside enantiomers | ► Subscribe | |||||||||||||||||||||||||||
| 5,539,116 | Method and compositions for the synthesis of BCH-189 and related compounds | ► Subscribe | |||||||||||||||||||||||||||
| 5,914,400 | Method and compositions for the synthesis of BCH-189 and related compounds | ► Subscribe | |||||||||||||||||||||||||||
| 5,728,575 | Method of resolution of 1,3-oxathiolane nucleoside enantiomers | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Norway | 20090593 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 4496377 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 3530150 | ► Subscribe | |||||||||||||||||||||||||||
| World Intellectual Property Organization (WIPO) | 2005112930 | ► Subscribe | |||||||||||||||||||||||||||
| Denmark | 1439177 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| /2015 | Austria | ► Subscribe | PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/830 (MITTEILUNG) 20130527 | ||||||||||||||||||||||||||
| 0859 | Netherlands | ► Subscribe | PRODUCT NAME: COBICISTAT, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN ATAZANAVIR, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER ATAZANAVIRSULFAAT; REGISTRATION NO/DATE: EU/1/15/1025 20150715 | ||||||||||||||||||||||||||
| C0013 | France | ► Subscribe | PRODUCT NAME: TENOFOVIR ALAFENAMIDE OU UN SEL OU UN SOLVATE DE TENOFOVIR ALAFENAMIDE,EN PARTICULIER LE FUMARATE DE TENOFOVIR ALAFENAMIDE; REGISTRATION NO/DATE: EU/1/15/1061 20151123 | ||||||||||||||||||||||||||
| 2013018,C1564210 | Lithuania | ► Subscribe | PRODUCT NAME: ELVITEGRAVIRUM; REGISTRATION NO/DATE: EU/1/13/830/001, 2013-05-24 EU/1/13/830/002 20130524 | ||||||||||||||||||||||||||
| C/GB04/016 | United Kingdom | ► Subscribe | PRODUCT NAME: EMTRICITABINE OR SALTS AND ESTERS THEREOF; REGISTERED: UK EU/1/03/261/001 20031024; UK EU/1/03/261/002 20031024; UK EU/1/03/261/003 20031024 | ||||||||||||||||||||||||||
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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 verifification 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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