BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE | N210251 | GILEAD SCIENCES INC
| Trial # | Patent | Type | Petitioner | Status | Filed | Decision |
|---|---|---|---|---|---|---|
| IPR2025-00033 | 11744802 | IPR | Cipla Limited | Institution Denied | 2024-10-28 | 2025-05-15 |
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Gilead Sciences, Inc. v. Lupin Ltd. et al 3 patentsANDA 217152, 217037, 216914bictegravir (BIC), tenofovir alafenamide (TAF), emtricitabine (FTC) | D. Del. | 2022-05-09 | Terminated 2025-10-06 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 8754065 | Aug 15, 2032PED: Feb 15, 2033 | PED | Yes | Yes | — | |
| 9216996 | Dec 19, 2033 | — | Yes | Yes | — | — |
| 9296769 | Aug 15, 2032PED: Feb 15, 2033 | PED | Yes | Yes | — | |
| 9708342 | Jun 19, 2035 | — | Yes | Yes | — | — |
| 9732092 | Dec 19, 2033 | — | Yes | Yes | — | — |
| 10385067 | Jun 19, 2035 | — | — | — | — | |
| 10548846 | Nov 8, 2036 | — | — | Yes | — | — |
| 11744802 | Nov 8, 2036 | — | — | Yes | — | — |
| 12594244 | Nov 8, 2036 | — | — | Yes | — |
| Code | Date | Status |
|---|---|---|
| I-942 | Feb 23, 2027 | < 1 year |
| M-305 | Apr 24, 2027 | < 1 year |
| ODE-256 | Jun 18, 2026 | Expired |
| ODE-468 | Feb 23, 2031 | Active |
| ODE-540 | Jul 30, 2032 | Active |
Orphan drug exclusivity was granted for Biktarvy (bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate) under designation ODE-540, providing seven years of regulatory exclusivity protection.
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Gilead Sciences added orphan drug exclusivity (ODE-540) to the Biktarvy (bictegravir sodium/emtricitabine/tenofovir alafenamide fumarate) supplemental application (NDA 210251-002), providing seven years of regulatory exclusivity for a designated...
New: New record