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VOSEVI Drug Profile
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» See Plans and PricingWhich patents cover Vosevi, and when can generic versions of Vosevi launch?
Vosevi is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are fifteen patents protecting this drug.
This drug has five hundred and twenty-one patent family members in forty-eight countries.
The generic ingredient in VOSEVI is sofosbuvir; velpatasvir; voxilaprevir. 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; voxilaprevir profile page.
US ANDA Litigation and Generic Entry Outlook for Vosevi
Vosevi will be eligible for patent challenges on June 28, 2020. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be July 17, 2034. 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 VOSEVI
| International Patents: | 521 |
| US Patents: | 15 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 1 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for VOSEVI |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for VOSEVI |
| DailyMed Link: | VOSEVI at DailyMed |
Generic Entry Opportunity Date for VOSEVI
Generic Entry Date for VOSEVI*:
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 VOSEVI
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Partners in Health | Phase 4 |
Recent Litigation for VOSEVI
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Gilead Sciences, Inc. v. Teva Pharmaceuticals USA, Inc. | 2018-03-27 |
| GILEAD SCIENCES, INC. v. NATCO PHARMA LIMITED | 2018-03-14 |
| Idenix Pharmaceuticals LLC v. Gilead Sciences, Inc. | 2014-07-01 |
PTAB Litigation
| Petitioner | Date |
|---|---|
| 2017-12-26 | |
| 2017-11-09 | |
| 2017-11-02 |
Pharmacology for VOSEVI
Synonyms for VOSEVI
| S900007740 |
| Sofosbuvir / velpatasvir / voxilaprevir |
| Sofosbuvir mixture with velpatasvir and voxilaprevir |
US Patents and Regulatory Information for VOSEVI
| 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 | VOSEVI | sofosbuvir; velpatasvir; voxilaprevir | TABLET;ORAL | 209195-001 | Jul 18, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Gilead Sciences Inc | VOSEVI | sofosbuvir; velpatasvir; voxilaprevir | TABLET;ORAL | 209195-001 | Jul 18, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Gilead Sciences Inc | VOSEVI | sofosbuvir; velpatasvir; voxilaprevir | TABLET;ORAL | 209195-001 | Jul 18, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | 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 VOSEVI
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 20140096029 | Start Trial |
| Hong Kong | 1213572 | Start Trial |
| Germany | 202008018643 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for VOSEVI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2203462 | 14C0082 | France | Start Trial | PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117 |
| 2203462 | 122014000108 | Germany | Start Trial | PRODUCT NAME: SOVALDI (SOFOSBUVIR); NAT. REGISTRATION NO/DATE: EU /1/13/894 20140116; FIRST REGISTRATION: EU EU/1/13/894 20140116 |
| 2203462 | C20140035 00135 | Estonia | Start Trial | PRODUCT NAME: SOFOSBUVIIR;REG NO/DATE: EU/1/13/894 17.01.2014 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
