DrugPatentWatch Database Preview
EPCLUSA Drug Profile
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When do Epclusa patents expire, and when can generic versions of Epclusa launch?
Epclusa is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are thirteen patents protecting this drug.
This drug has three hundred and eighty-four patent family members in forty-five countries.
The generic ingredient in EPCLUSA is sofosbuvir; velpatasvir. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sofosbuvir; velpatasvir profile page.
Summary for EPCLUSA
| International Patents: | 384 |
| US Patents: | 13 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 7 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for EPCLUSA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for EPCLUSA |
| DailyMed Link: | EPCLUSA at DailyMed |
Generic Entry Opportunity Date for EPCLUSA
*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 EPCLUSA
US Patents and Regulatory Information for EPCLUSA
| 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 | EPCLUSA | sofosbuvir; velpatasvir | TABLET;ORAL | 208341-001 | Jun 28, 2016 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Gilead Sciences Inc | EPCLUSA | sofosbuvir; velpatasvir | TABLET;ORAL | 208341-001 | Jun 28, 2016 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Gilead Sciences Inc | EPCLUSA | sofosbuvir; velpatasvir | TABLET;ORAL | 208341-001 | Jun 28, 2016 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Gilead Sciences Inc | EPCLUSA | sofosbuvir; velpatasvir | TABLET;ORAL | 208341-001 | Jun 28, 2016 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Gilead Sciences Inc | EPCLUSA | sofosbuvir; velpatasvir | TABLET;ORAL | 208341-001 | Jun 28, 2016 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Gilead Sciences Inc | EPCLUSA | sofosbuvir; velpatasvir | TABLET;ORAL | 208341-001 | Jun 28, 2016 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ 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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Non-Orange Book US Patents for EPCLUSA
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 |
|---|---|---|
| 9,393,256 | Methods for treating HCV | ➤ Sign Up |
| 8,859,756 | Stereoselective synthesis of phosphorus containing actives | ➤ Sign Up |
| 8,563,530 | Purine nucleoside phosphoramidate | ➤ Sign Up |
| 8,906,880 | Nucleoside phosphoramidate prodrugs | ➤ Sign Up |
| 9,637,512 | Nucleoside phosphoramidates | ➤ Sign Up |
| 9,051,340 | Antiviral compounds | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for EPCLUSA
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Denmark | 2609923 | ➤ Sign Up |
| Israel | 243988 | ➤ Sign Up |
| Japan | 2015028060 | ➤ Sign Up |
| Japan | 6073897 | ➤ Sign Up |
| Philippines | 12014502771 | ➤ Sign Up |
| New Zealand | 720856 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for EPCLUSA
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 00704 | Netherlands | ➤ Sign Up | PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117 |
| 0704 | Netherlands | ➤ Sign Up | PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117 |
| 2014 00061 | Denmark | ➤ Sign Up | PRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894/001-002 20140116 |
| 90066-6 | Sweden | ➤ Sign Up | PRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894 20140117 |
| 14/065 | Ireland | ➤ Sign Up | PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-EU/1/13/894/002 20140116 |
| 2014040,C2203462 | Lithuania | ➤ Sign Up | PRODUCT NAME: SOFOSBUVIRAS; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
