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VOSEVI Drug Profile
Which patents cover Vosevi, and what generic alternatives are available?
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 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.
Summary for VOSEVI
| International Patents: | 500 |
| 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 |
|---|---|
| Initiative for Medicines, Access & Knowledge (I-MAK), Inc. | 2017-12-26 |
| Initiative for Medicines, Access & Knowledge (I-MAK), Inc. | 2017-11-09 |
| Initiative for Medicines, Access & Knowledge (I-MAK), Inc. | 2017-11-02 |
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 | See Pricing | See Pricing | Y | Y | See Pricing | ||
| Gilead Sciences Inc | VOSEVI | sofosbuvir; velpatasvir; voxilaprevir | TABLET;ORAL | 209195-001 | Jul 18, 2017 | RX | Yes | Yes | See Pricing | See Pricing | Y | See Pricing | |||
| Gilead Sciences Inc | VOSEVI | sofosbuvir; velpatasvir; voxilaprevir | TABLET;ORAL | 209195-001 | Jul 18, 2017 | RX | Yes | Yes | See Pricing | See Pricing | Y | Y | See Pricing | ||
| >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 |
|---|---|---|
| Hungary | E036588 | See Pricing |
| Hungary | E039966 | See Pricing |
| South Korea | 101560994 | See Pricing |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for VOSEVI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2203462 | PA2014040 | Lithuania | See Pricing | PRODUCT NAME: SOFOSBUVIRUM; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116 |
| 2203462 | 122014000108 | Germany | See Pricing | PRODUCT NAME: SOVALDI (SOFOSBUVIR); NAT. REGISTRATION NO/DATE: EU /1/13/894 20140116; FIRST REGISTRATION: EU EU/1/13/894 20140116 |
| 2203462 | CR 2014 00061 | Denmark | See Pricing | PRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894/001-002 20140117 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
