DrugPatentWatch Database Preview
HARVONI Drug Profile
When do Harvoni patents expire, 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.
This drug has four hundred and forty-three patent family members in forty-five countries.
The generic ingredient in HARVONI is ledipasvir; sofosbuvir. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the ledipasvir; sofosbuvir profile page.
Summary for HARVONI
| International Patents: | 443 |
| US Patents: | 16 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 33 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for HARVONI |
| Drug Sales Revenues: | Drug sales revenues 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
Synonyms for HARVONI
| Ledipasvir / sofosbuvir |
| Ledipasvir and sofosbuvir |
| Ledipasvir mixture with sofosbuvir |
| S900006370 |
| Sofosbuvir / Ledipasvir |
| Sofosbuvir and Ledipasvir |
| Sofosbuvir/Ledipasvir |
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 | 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 | ||||
| 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 | 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 | ||
| 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 | Patent Number | Estimated Expiration |
|---|---|---|
| Cyprus | 1118045 | ➤ Sign Up |
| Mexico | 2009010401 | ➤ Sign Up |
| Spain | 2516466 | ➤ Sign Up |
| European Patent Office | 2709613 | ➤ Sign Up |
| Argentina | 082937 | ➤ Sign Up |
| Australia | 2010249481 | ➤ Sign Up |
| Country | Patent Number | Estimated Expiration |
Supplementary Protection Certificates for HARVONI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2203462 | PA2014040,C2203462 | Lithuania | ➤ Sign Up | PRODUCT NAME: SOFOSBUVIRAS; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116 |
| 2203462 | C02203462/01 | Switzerland | ➤ Sign Up | PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: SWISSMEDIC 63218 18.03.2014 |
| 2203462 | PA2014040 | Lithuania | ➤ Sign Up | PRODUCT NAME: SOFOSBUVIRUM; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116 |
| 2430014 | C20160002 00186 | Estonia | ➤ Sign Up | PRODUCT NAME: LEDIPASVIIR;REG NO/DATE: EU/1/14/958 18.11.2014 |
| 2430014 | 2016004 | Norway | ➤ Sign Up | PRODUCT NAME: LEDIPASVIR; REG. NO/DATE: EU/1/14/958 20141203 |
| 2203462 | C300704 | Netherlands | ➤ Sign Up | PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117 |
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
