sofosbuvir; velpatasvir · Gilead Sciences Inc · NDA 208341, 214187
Epclusa
Earliest generic entry, as listed · earliest of 4 marketed strengths
30 Jul 2034
Blocked by patent: US 10086011, US 11116783, US 11707479, US 9757406.
Listed patents · 32 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10086011 | — | 30 Jul 2034 |
| US 11116783 | — | 30 Jul 2034 |
| US 11707479 | — | 30 Jul 2034 |
| US 9757406 | — | 30 Jul 2034 |
| US 10086011 | use U-1470 | 30 Jan 2034 |
| US 11116783 | product, use U-1470 | 30 Jan 2034 |
| US 11707479 | product, use U-1470 | 30 Jan 2034 |
| US 9757406 | product | 30 Jan 2034 |
| US 8575135 | — | 16 May 2033 |
| US 8921341 | — | 16 May 2033 |
| US 8940718 | — | 16 May 2033 |
| US 8575135 | substance, product, use U-1470 | 16 Nov 2032 |
| US 8921341 | substance, product, use U-1470 | 16 Nov 2032 |
| US 8940718 | substance, product, use U-1470 | 16 Nov 2032 |
| 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 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 8334270 | — | 21 Sep 2028 |
| US 8580765 | — | 21 Sep 2028 |
| US 8735372 | — | 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 8735372 | use U-1470 | 21 Mar 2028 |
| US 9085573 | substance, product, use U-1470 | 21 Mar 2028 |
Exclusivities · 5 unexpired
| PED | pediatric (6 months added) | 10 Dec 2028 |
| ODE-376 | orphan drug (7 years) | 10 Jun 2028 |
| PED | pediatric (6 months added) | 19 Sep 2027 |
| ODE-293 | orphan drug (7 years) | 19 Mar 2027 |
| ODE* | 19 Mar 2027 |
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 |
|---|---|---|---|
| 208341 · 001 · RLD | tablet, oral | 400MG;100MG | 30 Jul 2034 |
| 208341 · 002 · RLD | tablet, oral | 200MG;50MG | 30 Jul 2034 |
| 214187 · 001 · RLD | pellets, oral | 150MG/PACKET;37.5MG/PACKET | 30 Jul 2034 |
| 214187 · 002 · RLD | pellets, oral | 200MG/PACKET;50MG/PACKET | 30 Jul 2034 |