FDA Orange Book · active-ingredient family
Ledipasvir; sofosbuvir
Ledipasvir; sofosbuvir is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:HARVONI · NDA 212477
2
Brand (NDA)
0
Generics (ANDA)
33
Listed patents
8
Exclusivity periods
Brand (NDA) products · pellets, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| HARVONIRLD×2 | GILEAD SCIENCES INC | NDA 212477 | — | Aug 28, 2019 | |
| HARVONIRLD×2 | GILEAD SCIENCES INC | NDA 205834 | — | Aug 28, 2019 |
Marketing exclusivity (8)
- ODE-262Orphan-drug exclusivity (7 years)
Aug 28, 2026
in 2 mo
- ODE-263Orphan-drug exclusivity (7 years)
Aug 28, 2026
in 2 mo
- ODE-264Orphan-drug exclusivity (7 years)
Aug 28, 2026
in 2 mo
- ODE-262Orphan-drug exclusivity (7 years)
Aug 28, 2026
in 2 mo
- ODE-263Orphan-drug exclusivity (7 years)
Aug 28, 2026
in 2 mo
- ODE-264Orphan-drug exclusivity (7 years)
Aug 28, 2026
in 2 mo
- ODE*FDA marketing exclusivity
Aug 28, 2026
in 2 mo
- ODE*FDA marketing exclusivity
Aug 28, 2026
in 2 mo
Listed patents (33)
| 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 |
| 8633309 | Mar 26, 2029 | in 2 yr 10 mo | SubstanceProductU-1470 |
| 8889159 | Mar 26, 2029 | in 2 yr 10 mo | ProductU-1470 |
| 7964580*PED | Sep 26, 2029 | in 3 yr 4 mo | |
| 8633309*PED | Sep 26, 2029 | in 3 yr 4 mo | |
| 8889159*PED | Sep 26, 2029 | in 3 yr 4 mo | |
| 8273341 | May 12, 2030 | in 3 yr 11 mo | U-1470 |
| 8822430 | May 12, 2030 | in 3 yr 11 mo | SubstanceProductU-1470 |
| 8841278 | May 12, 2030 | in 3 yr 11 mo | ProductU-1470 |
| 9511056 | May 12, 2030 | in 3 yr 11 mo | U-1470 |
| 8088368 | May 12, 2030 | in 3 yr 11 mo | SubstanceProduct |
| 9284342 | Sep 13, 2030 | in 4 yr 4 mo | SubstanceProductU-1470 |
| 8273341*PED | Nov 12, 2030 | in 4 yr 6 mo | |
| 8088368*PED | Nov 12, 2030 | in 4 yr 6 mo | |
| 8822430*PED | Nov 12, 2030 | in 4 yr 6 mo | |
| 8841278*PED | Nov 12, 2030 | in 4 yr 6 mo | |
| 9511056*PED | Nov 12, 2030 | in 4 yr 6 mo | |
| 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 | |
| 9393256 | Sep 14, 2032 | in 6 yr 4 mo | U-1470 |
| 10456414 | Sep 14, 2032 | in 6 yr 4 mo | Product |
| 9393256*PED | Mar 14, 2033 | in 6 yr 10 mo | |
| 10039779 | Jan 30, 2034 | in 7 yr 9 mo | SubstanceProductU-1470 |
| 10039779*PED | Jul 30, 2034 | in 8 yr 3 mo |
Ledipasvir; sofosbuvir — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
