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Generated: September 22, 2017
What is the patent landscape for Harvoni, and what generic Harvoni alternatives are available?
Harvoni is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are fifteen patents protecting this drug.| Patents: | 15 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 1 |
| Clinical Trials: see list | 31 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | HARVONI at DailyMed |
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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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,859,756 | Stereoselective synthesis of phosphorus containing actives | ► Subscribe | |||||||||||||||||||||||||||
| 8,642,756 | Nucleoside phosphoramidates | ► Subscribe | |||||||||||||||||||||||||||
| 8,906,880 | Nucleoside phosphoramidate prodrugs | ► Subscribe | |||||||||||||||||||||||||||
| 8,669,234 | Antiviral compounds | ► Subscribe | |||||||||||||||||||||||||||
| 9,206,217 | Nucleoside phosphoramidates | ► Subscribe | |||||||||||||||||||||||||||
| 8,575,118 | Antiviral compounds | ► Subscribe | |||||||||||||||||||||||||||
| 9,585,906 | Nucleoside phosphoramidate prodrugs | ► Subscribe | |||||||||||||||||||||||||||
| 8,629,263 | Nucleoside phosphoramidates | ► Subscribe | |||||||||||||||||||||||||||
| 8,735,569 | Nucleoside phosphoramidates | ► Subscribe | |||||||||||||||||||||||||||
| 8,957,046 | Nucleoside phosphoramidate prodrugs | ► Subscribe | |||||||||||||||||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||||||||||||||||
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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Brazil | 112014010295 | ► Subscribe | |||||||||||||||||||||||||||
| Mexico | 2009010401 | ► Subscribe | |||||||||||||||||||||||||||
| Croatia | P20140667 | ► Subscribe | |||||||||||||||||||||||||||
| World Intellectual Property Organization (WIPO) | 2011123645 | ► Subscribe | |||||||||||||||||||||||||||
| Croatia | P20160958 | ► Subscribe | |||||||||||||||||||||||||||
| Brazil | PI0823519 | ► Subscribe | |||||||||||||||||||||||||||
| Eurasian Patent Organization | 027493 | ► Subscribe | |||||||||||||||||||||||||||
| Norway | 2016004 | ► Subscribe | |||||||||||||||||||||||||||
| Israel | 222810 | ► Subscribe | |||||||||||||||||||||||||||
| Israel | 233679 | ► 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.
Export unavailable in trial.
Subscribe for complete access.
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 90066-6 | Sweden | ► Subscribe | PRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894 20140117 | ||||||||||||||||||||||||||
| 2014040,C2203462 | Lithuania | ► Subscribe | PRODUCT NAME: SOFOSBUVIRAS; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116 | ||||||||||||||||||||||||||
| C0005 | France | ► Subscribe | PRODUCT NAME: LEDIPASVIR; REGISTRATION NO/DATE: EU/1/14/958/001-002 20141118 | ||||||||||||||||||||||||||
| 4 5029-2014 | Slovakia | ► Subscribe | PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894 20140117 | ||||||||||||||||||||||||||
| 0796 | Netherlands | ► Subscribe | PRODUCT NAME: LEDIPASVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/14/958 20141118 | ||||||||||||||||||||||||||
| 2014000108 | Germany | ► Subscribe | PRODUCT NAME: SOVALDI (SOFOSBUVIR); NAT. REGISTRATION NO/DATE: EU /1/13/894 20140116; FIRST REGISTRATION: EU EU/1/13/894 20140116 | ||||||||||||||||||||||||||
| 0140035 00135 | Estonia | ► Subscribe | PRODUCT NAME: SOFOSBUVIIR;REG NO/DATE: EU/1/13/894 17.01.2014 | ||||||||||||||||||||||||||
| 14/065 | Ireland | ► Subscribe | PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-EU/1/13/894/002 20140116 | ||||||||||||||||||||||||||
| 2016000009 | Germany | ► Subscribe | PRODUCT NAME: LEDIPASVIR; REGISTRATION NO/DATE: EU/1/14/958 20141117 | ||||||||||||||||||||||||||
| 00704 | Netherlands | ► Subscribe | PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117 | ||||||||||||||||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||||||||||||||||
Export unavailable in trial.
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Serving 500+ biopharmaceutical companies globally:
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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