COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | N203100 | GILEAD SCIENCES INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Gilead Sciences, Inc. FDA-2016-P-3312 · 3 docket documents Gilead Sciences, Inc. filed this citizen petition under sections 505(c)(3)(E) and 505(j)(5)(F) of the Federal Food, Drug, and Cosmetic Act requesting that FDA award five-year new chemical entity exclusivity to Stribild (cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate), approve | 505(q) | 2016-10-18 | Withdrawn | Gilead Sciences, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$149.63
per ea
Lowest NADAC/Unit
$149.63
per ea
Brand NDCs
1
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 61958120101STRIBILD TABLET | $149.63 | EA | Brand | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 7176220 | Aug 27, 2026PED: Feb 27, 2027 | PED | Yes | Yes | — | |
| 7635704 | Oct 26, 2026PED: Apr 26, 2027 | PED | Yes | Yes | — | |
| 8148374 | Sep 3, 2029PED: Mar 3, 2030 | PED | Yes | Yes | — | |
| 8633219 | Apr 30, 2030PED: Oct 30, 2030 | PED | — | Yes | — | |
| 8981103 | Oct 26, 2026PED: Apr 26, 2027 | PED | Yes | Yes | — | — |
| 9891239 | Sep 3, 2029PED: Mar 3, 2030 | PED | — | Yes | — | |
| 10039718 | Oct 6, 2032PED: Apr 6, 2033 | PED | — | Yes | — | — |