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SOVALDI Drug Profile
» See Plans and Pricing
Which patents cover Sovaldi, and when can generic versions of Sovaldi launch?
Sovaldi is a drug marketed by Gilead Sciences Inc and is included in two NDAs. There are nine patents protecting this drug and one Paragraph IV challenge.
This drug has three hundred and forty-four patent family members in forty-seven countries.
The generic ingredient in SOVALDI is sofosbuvir. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sofosbuvir profile page.
DrugPatentWatch® Generic Entry Outlook for Sovaldi
Sovaldi was eligible for patent challenges on December 6, 2017.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be June 11, 2031. This may change due to patent challenges or generic licensing.
There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for SOVALDI
| International Patents: | 344 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 35 |
| Clinical Trials: | 32 |
| Patent Applications: | 1,008 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for SOVALDI |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for SOVALDI |
| What excipients (inactive ingredients) are in SOVALDI? | SOVALDI excipients list |
| DailyMed Link: | SOVALDI at DailyMed |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for SOVALDI
Generic Entry Dates for SOVALDI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
PELLETS;ORAL |
Generic Entry Dates for SOVALDI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL |
*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.
Recent Clinical Trials for SOVALDI
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Assiut University | Early Phase 1 |
| Ginkgopharma CO., LTD | Phase 2 |
| Ginkgopharma CO., LTD | Phase 3 |
Pharmacology for SOVALDI
| Drug Class | Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor |
| Mechanism of Action | RNA Replicase Inhibitors |
Paragraph IV (Patent) Challenges for SOVALDI
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| SOVALDI | TABLET;ORAL | sofosbuvir | 204671 | 2017-12-06 |
US Patents and Regulatory Information for SOVALDI
| 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 | SOVALDI | sofosbuvir | TABLET;ORAL | 204671-001 | Dec 6, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Gilead Sciences Inc | SOVALDI | sofosbuvir | TABLET;ORAL | 204671-001 | Dec 6, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Gilead Sciences Inc | SOVALDI | sofosbuvir | TABLET;ORAL | 204671-001 | Dec 6, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Gilead Sciences Inc | SOVALDI | sofosbuvir | TABLET;ORAL | 204671-001 | Dec 6, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| >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 SOVALDI
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Chile | 2008000902 | Start Trial |
| Hong Kong | 1213571 | Start Trial |
| Mexico | 2012011171 | Start Trial |
| South Korea | 101715981 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for SOVALDI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2203462 | 67/2014 | Austria | Start Trial | PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894 20140117 |
| 2203462 | CR 2014 00061 | Denmark | Start Trial | PRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894/001-002 20140117 |
| 2203462 | 300704 | Netherlands | Start Trial | PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117 |
| 2203462 | 214 5029-2014 | Slovakia | Start Trial | PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894 20140117 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
