DrugPatentWatch Database Preview
HARVONI Drug Profile
Which patents cover Harvoni, and what generic alternatives are available?
Harvoni is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are sixteen patents protecting this drug.
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
| US Patents: | 16 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 32 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for HARVONI |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for HARVONI |
| DailyMed Link: | HARVONI at DailyMed |
Generic Entry Opportunity Date for HARVONI
*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 HARVONI
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 | ➤ 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 | |||
| Gilead Sciences Inc | HARVONI | ledipasvir; sofosbuvir | TABLET;ORAL | 205834-001 | Oct 10, 2014 | 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 |
International Patents for HARVONI
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Singapore | 2014011704 | ➤ Sign Up |
| Moldova, Republic of | 20140035 | ➤ Sign Up |
| Japan | 2014196305 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for HARVONI
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2 5001-2016 | Slovakia | ➤ Sign Up | PRODUCT NAME: LEDIPASVIR; REGISTRATION NO/DATE: EU/1/14/958 20141118 |
| 2014040 | Lithuania | ➤ Sign Up | PRODUCT NAME: SOFOSBUVIRUM; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116 |
| 2016 00006 | Denmark | ➤ Sign Up | PRODUCT NAME: LEDIPASVIR; REG. NO/DATE: EU/1/14/958/001-002 20141118 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
