bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate · Gilead Sciences Inc · NDA 210251
Biktarvy
Earliest generic entry, as listed · earliest of 2 marketed strengths
8 Nov 2036
Blocked by patent: US 10548846, US 11744802, US 12594244.
Listed patents · 9 unexpired
11 Orange Book listing rows for 9 patents, including 2 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 10548846 | drug product · sets the listed date | 8 Nov 2036 |
| US 11744802 | drug product · sets the listed date | 8 Nov 2036 |
| US 12594244 | drug product, use U-257 · sets the listed date | 8 Nov 2036 |
| US 10385067 | use U-257 | 19 Jun 2035 |
| US 9708342 | drug substance, drug product | 19 Jun 2035 |
| US 9216996 | drug substance, drug product | 19 Dec 2033 |
| US 9732092 | drug substance, drug product | 19 Dec 2033 |
| US 8754065 | drug substance, drug product, use U-257 | 15 Feb 2033 |
| US 8754065 listing row | drug substance, drug product, use U-257 | 15 Aug 2032 |
| US 8754065 listing row | pediatric extension | 15 Feb 2033 |
| US 9296769 | drug substance, drug product, use U-257 | 15 Feb 2033 |
| US 9296769 listing row | drug substance, drug product, use U-257 | 15 Aug 2032 |
| US 9296769 listing row | pediatric extension | 15 Feb 2033 |
Exclusivities · 5 unexpired
| ODE-540 | orphan drug (7 years) | 30 Jul 2032 |
| ODE-468 | orphan drug (7 years) | 23 Feb 2031 |
| ODE-378 | orphan drug (7 years) | 7 Oct 2028 |
| M-305 | miscellaneous (3 years) | 24 Apr 2027 |
| I-942 | new indication (3 years) | 23 Feb 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 · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 210251 · 001 · RLD | tablet, oral | EQ 50MG BASE;200MG;EQ 25MG BASE | 8 Nov 2036 |
| 210251 · 002 · RLD | tablet, oral | EQ 30MG BASE;120MG;EQ 15MG BASE | 8 Nov 2036 |
Expired or delisted (1)
- ODE-256 · 18 Jun 2026