Orange Book product · Brand (NDA)
HARVONI
LEDIPASVIR; SOFOSBUVIR
At a glance
Aug 28, 2019
Approved
Brand (NDA)
Application
Not listed
TE code
31
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 28, 2019
6 yr 11 mo ago
Today
Exclusivity ends · ODE-262
Orphan-drug exclusivity (7 years)
Aug 28, 2026
in 2 mo
Exclusivity ends · ODE-263
Orphan-drug exclusivity (7 years)
Aug 28, 2026
in 2 mo
Exclusivity ends · ODE-264
Orphan-drug exclusivity (7 years)
Aug 28, 2026
in 2 mo
Patent 8334270 expires
Listed drug substance patent expiration.
Mar 21, 2028
in 1 yr 9 mo
Patent 8580765 expires
Listed drug substance patent expiration.
Mar 21, 2028
in 1 yr 9 mo
Patent 8735372 expires
Listed method-of-use patent (U-1470) expiration.
Mar 21, 2028
in 1 yr 9 mo
Patent 9085573 expires
Listed drug substance patent expiration.
Mar 21, 2028
in 1 yr 9 mo
Patent 8334270*PED expires
Listed listed patent expiration.
Sep 21, 2028
in 2 yr 4 mo
Patent 8580765*PED expires
Listed listed patent expiration.
Sep 21, 2028
in 2 yr 4 mo
Patent 8735372*PED expires
Listed listed patent expiration.
Sep 21, 2028
in 2 yr 4 mo
Patent 9085573*PED expires
Listed listed patent expiration.
Sep 21, 2028
in 2 yr 4 mo
Patent 7964580 expires
Listed drug substance patent expiration.
Mar 26, 2029
in 2 yr 10 mo
Patent 8633309 expires
Listed drug substance patent expiration.
Mar 26, 2029
in 2 yr 10 mo
Patent 8889159 expires
Listed drug product patent expiration.
Mar 26, 2029
in 2 yr 10 mo
Patent 7964580*PED expires
Listed listed patent expiration.
Sep 26, 2029
in 3 yr 4 mo
Patent 8633309*PED expires
Listed listed patent expiration.
Sep 26, 2029
in 3 yr 4 mo
Patent 8889159*PED expires
Listed listed patent expiration.
Sep 26, 2029
in 3 yr 4 mo
Patent 8088368 expires
Listed drug substance patent expiration.
May 12, 2030
in 3 yr 11 mo
Patent 8273341 expires
Listed method-of-use patent (U-1470) expiration.
May 12, 2030
in 3 yr 11 mo
Patent 8822430 expires
Listed drug substance patent expiration.
May 12, 2030
in 3 yr 11 mo
Patent 8841278 expires
Listed drug product patent expiration.
May 12, 2030
in 3 yr 11 mo
Patent 9511056 expires
Listed method-of-use patent (U-1470) expiration.
May 12, 2030
in 3 yr 11 mo
Patent 9284342 expires
Listed drug substance patent expiration.
Sep 13, 2030
in 4 yr 4 mo
Patent 8088368*PED expires
Listed listed patent expiration.
Nov 12, 2030
in 4 yr 6 mo
Patent 8273341*PED expires
Listed listed patent expiration.
Nov 12, 2030
in 4 yr 6 mo
Patent 8822430*PED expires
Listed listed patent expiration.
Nov 12, 2030
in 4 yr 6 mo
Patent 8841278*PED expires
Listed listed patent expiration.
Nov 12, 2030
in 4 yr 6 mo
Patent 9511056*PED expires
Listed listed patent expiration.
Nov 12, 2030
in 4 yr 6 mo
Patent 8618076 expires
Listed drug substance patent expiration.
Dec 11, 2030
in 4 yr 7 mo
Patent 9284342*PED expires
Listed listed patent expiration.
Mar 13, 2031
in 4 yr 10 mo
Patent 8618076*PED expires
Listed listed patent expiration.
Jun 11, 2031
in 5 yr 1 mo
Patent 10456414 expires
Listed drug product patent expiration.
Sep 14, 2032
in 6 yr 4 mo
Patent 9393256 expires
Listed method-of-use patent (U-1470) expiration.
Sep 14, 2032
in 6 yr 4 mo
Patent 9393256*PED expires
Listed listed patent expiration.
Mar 14, 2033
in 6 yr 10 mo
Pharmaceutical detail
Active ingredient
LEDIPASVIR; SOFOSBUVIR
Strength
45MG;200MG/PACKET
Dosage form
PELLETS
Route
ORAL
TE code
Not listed
Application
NDA 212477
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (3)
- 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
Listed patents (31)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8334270 | Mar 21, 2028 | in 1 yr 9 mo | SubstanceProductU-1470 |
| 8580765 | 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 |
| 8334270*PED | Sep 21, 2028 | in 2 yr 4 mo | |
| 8580765*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 | |
| 8088368 | May 12, 2030 | in 3 yr 11 mo | SubstanceProduct |
| 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 |
| 9284342 | Sep 13, 2030 | in 4 yr 4 mo | SubstanceProductU-1470 |
| 8088368*PED | Nov 12, 2030 | in 4 yr 6 mo | |
| 8273341*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 | |
| 10456414 | Sep 14, 2032 | in 6 yr 4 mo | Product |
| 9393256 | Sep 14, 2032 | in 6 yr 4 mo | U-1470 |
| 9393256*PED | Mar 14, 2033 | in 6 yr 10 mo |
