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Generated: July 24, 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 | 29 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | HARVONI at DailyMed |
| 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 | HARVONI | ledipasvir; sofosbuvir | TABLET;ORAL | 205834-001 | Oct 10, 2014 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Gilead Sciences Inc | HARVONI | ledipasvir; sofosbuvir | TABLET;ORAL | 205834-001 | Oct 10, 2014 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Gilead Sciences Inc | HARVONI | ledipasvir; sofosbuvir | TABLET;ORAL | 205834-001 | Oct 10, 2014 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Gilead Sciences Inc | HARVONI | ledipasvir; sofosbuvir | TABLET;ORAL | 205834-001 | Oct 10, 2014 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Gilead Sciences Inc | HARVONI | ledipasvir; sofosbuvir | TABLET;ORAL | 205834-001 | Oct 10, 2014 | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 9,549,941 | Compositions and methods for treating hepatitis C virus | ► Subscribe | |||||||||||||||||||||||||||
| 8,859,756 | Stereoselective synthesis of phosphorus containing actives | ► Subscribe | |||||||||||||||||||||||||||
| 8,906,880 | Nucleoside phosphoramidate prodrugs | ► Subscribe | |||||||||||||||||||||||||||
| 8,563,530 | Purine nucleoside phosphoramidate | ► Subscribe | |||||||||||||||||||||||||||
| 9,206,217 | Nucleoside phosphoramidates | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Japan | 5872539 | ► Subscribe | |||||||||||||||||||||||||||
| Slovenia | 2203462 | ► Subscribe | |||||||||||||||||||||||||||
| New Zealand | 596444 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 2826784 | ► Subscribe | |||||||||||||||||||||||||||
| South Korea | 20140122705 | ► 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2014000108 | Germany | ► Subscribe | PRODUCT NAME: SOVALDI (SOFOSBUVIR); NAT. REGISTRATION NO/DATE: EU /1/13/894 20140116; FIRST REGISTRATION: EU EU/1/13/894 20140116 | ||||||||||||||||||||||||||
| 2014040 | Lithuania | ► Subscribe | PRODUCT NAME: SOFOSBUVIRUM; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116 | ||||||||||||||||||||||||||
| 600 | Luxembourg | ► Subscribe | PRODUCT NAME: SOVALDI (SOFOSBUVIR). FIRST REGISTRATION: 20140117 | ||||||||||||||||||||||||||
| 90066-6 | Sweden | ► Subscribe | PRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894 20140117 | ||||||||||||||||||||||||||
| 0160002 00186 | Estonia | ► Subscribe | PRODUCT NAME: LEDIPASVIIR;REG NO/DATE: EU/1/14/958 18.11.2014 | ||||||||||||||||||||||||||
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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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