DrugPatentWatch Database Preview
HARVONI Drug Profile
When do Harvoni patents expire, and what generic alternatives are available?
This drug has four hundred and three patent family members in forty-five countries.
The generic ingredient in HARVONI is ledipasvir; sofosbuvir. One supplier is listed for this compound. Additional details are available on the ledipasvir; sofosbuvir profile page.
Summary for HARVONI
| International Patents: | 403 |
| US Patents: | 15 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 32 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | HARVONI at DailyMed |
US Patents and Regulatory Information for HARVONI
| 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 | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Gilead Sciences Inc | HARVONI | ledipasvir; sofosbuvir | TABLET;ORAL | 205834-001 | Oct 10, 2014 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Gilead Sciences Inc | HARVONI | ledipasvir; sofosbuvir | TABLET;ORAL | 205834-001 | Oct 10, 2014 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Gilead Sciences Inc | HARVONI | ledipasvir; sofosbuvir | TABLET;ORAL | 205834-001 | Oct 10, 2014 | 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 |
Non-Orange Book US Patents for HARVONI
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 |
|---|---|---|
| 9,585,906 | Nucleoside phosphoramidate prodrugs | ➤ Sign Up |
| 8,629,263 | Nucleoside phosphoramidates | ➤ Sign Up |
| 8,575,118 | Antiviral compounds | ➤ Sign Up |
| 8,906,880 | Nucleoside phosphoramidate prodrugs | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
International Patents for HARVONI
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Costa Rica | 20140273 | ➤ Sign Up |
| South Africa | 201400249 | ➤ Sign Up |
| Argentina | 088580 | ➤ Sign Up |
| South Korea | 20100016041 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for HARVONI
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2016002,C2430014 | Lithuania | ➤ Sign Up | PRODUCT NAME: LEDIPASVIRAS; REGISTRATION NO/DATE: EU/1/14/958(001-002) 20141117 |
| 2203462/01 | Switzerland | ➤ Sign Up | PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: SWISSMEDIC 63218 18.03.2014 |
| 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 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
