FDA Orange Book · active-ingredient family
Sofosbuvir; velpatasvir
Sofosbuvir; velpatasvir is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:EPCLUSA · NDA 214187
2
Brand (NDA)
0
Generics (ANDA)
32
Listed patents
8
Exclusivity periods
Brand (NDA) products · pellets, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| EPCLUSARLD×2 | GILEAD SCIENCES INC | NDA 214187 | — | Jun 10, 2021 | |
| EPCLUSARLD×2 | GILEAD SCIENCES INC | NDA 208341 | — | Mar 19, 2020 |
Marketing exclusivity (8)
- ODE-376Orphan-drug exclusivity (7 years)
Jun 10, 2028
in 2 yr
- PEDPediatric exclusivity (adds 6 months)
Dec 10, 2028
in 2 yr 6 mo
- ODE*FDA marketing exclusivity
Mar 19, 2027
in 9 mo
- PEDPediatric exclusivity (adds 6 months)
Sep 19, 2027
in 1 yr 3 mo
- ODE-293Orphan-drug exclusivity (7 years)
Mar 19, 2027
in 9 mo
- PEDPediatric exclusivity (adds 6 months)
Sep 19, 2027
in 1 yr 3 mo
- ODE-293Orphan-drug exclusivity (7 years)
Mar 19, 2027
in 9 mo
- PEDPediatric exclusivity (adds 6 months)
Sep 19, 2027
in 1 yr 3 mo
Listed patents (32)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8580765 | Mar 21, 2028 | in 1 yr 9 mo | SubstanceProductU-1470 |
| 8334270 | Mar 21, 2028 | in 1 yr 9 mo | SubstanceProductU-1470 |
| 8735372 | Mar 21, 2028 | in 1 yr 9 mo | U-1470 |
| 9085573 | Mar 21, 2028 | in 1 yr 9 mo | SubstanceProductU-1470 |
| 8580765*PED | Sep 21, 2028 | in 2 yr 4 mo | |
| 8334270*PED | Sep 21, 2028 | in 2 yr 4 mo | |
| 8735372*PED | Sep 21, 2028 | in 2 yr 4 mo | |
| 9085573*PED | Sep 21, 2028 | in 2 yr 4 mo | |
| 7964580 | Mar 26, 2029 | in 2 yr 10 mo | SubstanceProductU-1470 |
| 8889159 | Mar 26, 2029 | in 2 yr 10 mo | ProductU-1470 |
| 8633309 | Mar 26, 2029 | in 2 yr 10 mo | SubstanceProductU-1470 |
| 7964580*PED | Sep 26, 2029 | in 3 yr 4 mo | |
| 8889159*PED | Sep 26, 2029 | in 3 yr 4 mo | |
| 8633309*PED | Sep 26, 2029 | in 3 yr 4 mo | |
| 9284342 | Sep 13, 2030 | in 4 yr 4 mo | SubstanceProductU-1470 |
| 8618076 | Dec 11, 2030 | in 4 yr 7 mo | SubstanceProductU-1470 |
| 9284342*PED | Mar 13, 2031 | in 4 yr 10 mo | |
| 8618076*PED | Jun 11, 2031 | in 5 yr 1 mo | |
| 8575135 | Nov 16, 2032 | in 6 yr 6 mo | SubstanceProductU-1470 |
| 8921341 | Nov 16, 2032 | in 6 yr 6 mo | SubstanceProductU-1470 |
| 8940718 | Nov 16, 2032 | in 6 yr 6 mo | SubstanceProductU-1470 |
| 8575135*PED | May 16, 2033 | in 7 yr | |
| 8921341*PED | May 16, 2033 | in 7 yr | |
| 8940718*PED | May 16, 2033 | in 7 yr | |
| 11116783 | Jan 30, 2034 | in 7 yr 9 mo | ProductU-1470 |
| 11707479 | Jan 30, 2034 | in 7 yr 9 mo | ProductU-1470 |
| 10086011 | Jan 30, 2034 | in 7 yr 9 mo | U-1470 |
| 9757406 | Jan 30, 2034 | in 7 yr 9 mo | Product |
| 11116783*PED | Jul 30, 2034 | in 8 yr 3 mo | |
| 11707479*PED | Jul 30, 2034 | in 8 yr 3 mo | |
| 10086011*PED | Jul 30, 2034 | in 8 yr 3 mo | |
| 9757406*PED | Jul 30, 2034 | in 8 yr 3 mo |
Sofosbuvir; velpatasvir — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
