sofosbuvir · Gilead Sciences Inc · NDA 204671, 212480
Sovaldi
Earliest generic entry, as listed · earliest of 4 marketed strengths
11 Jun 2031
Blocked by patent: US 8618076.
Listed patents · 18 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8618076 | — | 11 Jun 2031 |
| US 9284342 | — | 13 Mar 2031 |
| US 8618076 | substance, product, use U-1470 | 11 Dec 2030 |
| US 9284342 | substance, product, use U-1470 | 13 Sep 2030 |
| US 7964580 | — | 26 Sep 2029 |
| US 8633309 | — | 26 Sep 2029 |
| US 8889159 | — | 26 Sep 2029 |
| US 9549941 | — | 26 Sep 2029 |
| US 7964580 | substance, product, use U-1470 | 26 Mar 2029 |
| US 8633309 | substance, product, use U-1470 | 26 Mar 2029 |
| US 8889159 | product, use U-1470 | 26 Mar 2029 |
| US 9549941 | use U-1958 | 26 Mar 2029 |
| US 8334270 | — | 21 Sep 2028 |
| US 8580765 | — | 21 Sep 2028 |
| US 9085573 | — | 21 Sep 2028 |
| US 8334270 | substance, product, use U-1470 | 21 Mar 2028 |
| US 8580765 | substance, product, use U-1470 | 21 Mar 2028 |
| US 9085573 | substance, product, use U-1470 | 21 Mar 2028 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 204671 · 001 · RLD | tablet, oral | 400MG | 11 Jun 2031 |
| 204671 · 002 · RLD | tablet, oral | 200MG | 11 Jun 2031 |
| 212480 · 001 · RLD | pellets, oral | 150MG/PACKET | 11 Jun 2031 |
| 212480 · 002 · RLD | pellets, oral | 200MG/PACKET | 11 Jun 2031 |
Expired or delisted (2)
- ODE* · 28 Aug 2026
- ODE-258 · 28 Aug 2026