ledipasvir; sofosbuvir · Gilead Sciences Inc · NDA 205834, 212477
Harvoni
Earliest generic entry, as listed · earliest of 4 marketed strengths
14 Mar 2033
Other strengths are listed to 30 Jul 2034.
Blocked by patent: US 9393256.
Listed patents · 35 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10039779 | — | 30 Jul 2034 |
| US 10039779 | substance, product, use U-1470 | 30 Jan 2034 |
| US 10039779 | substance, product, use U-2370 | 30 Jan 2034 |
| US 10039779 | substance, product, use U-2369 | 30 Jan 2034 |
| US 9393256 | — | 14 Mar 2033 |
| US 10456414 | product | 14 Sep 2032 |
| US 9393256 | use U-1470 | 14 Sep 2032 |
| US 8618076 | — | 11 Jun 2031 |
| US 9284342 | — | 13 Mar 2031 |
| US 8618076 | substance, product, use U-1470 | 11 Dec 2030 |
| US 8088368 | — | 12 Nov 2030 |
| US 8273341 | — | 12 Nov 2030 |
| US 8822430 | — | 12 Nov 2030 |
| US 8841278 | — | 12 Nov 2030 |
| US 9511056 | — | 12 Nov 2030 |
| US 9284342 | substance, product, use U-1470 | 13 Sep 2030 |
| US 8088368 | substance, product | 12 May 2030 |
| US 8273341 | use U-1470 | 12 May 2030 |
| US 8822430 | substance, product, use U-1470 | 12 May 2030 |
| US 8841278 | product, use U-1470 | 12 May 2030 |
| US 9511056 | use U-1470 | 12 May 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 · 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 |
|---|---|---|---|
| 205834 · 001 · RLD | tablet, oral | 90MG;400MG | 30 Jul 2034 |
| 205834 · 002 · RLD | tablet, oral | 45MG;200MG | 30 Jul 2034 |
| 212477 · 001 · RLD | pellets, oral | 33.75MG/PACKET;150MG/PACKET | 14 Mar 2033 |
| 212477 · 002 · RLD | pellets, oral | 45MG/PACKET;200MG/PACKET | 14 Mar 2033 |
Expired or delisted (4)
- ODE* · 28 Aug 2026
- ODE-262 · 28 Aug 2026
- ODE-263 · 28 Aug 2026
- ODE-264 · 28 Aug 2026