EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | N021752 | GILEAD SCIENCES INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2018-11-06 | Terminated 2018-11-15 | — | |
GILEAD SCIENCES, INC. et al v. STRIDES PHARMA, INC. et al 6 patentsANDA 091055emtricitabine and tenofovir disoproxil fumarate | D.N.J. | 2018-06-27 | Terminated 2019-01-09 | — |
Gilead Sciences, Inc. et al v. Aurobindo Pharma Ltd. et al 2 patentsANDA 211640emtricitabine and tenofovir disoproxil fumarate | D. Del. | 2018-05-18 | Terminated 2018-10-10 | — |
| D. Del. | 2017-07-27 | Terminated 2017-12-21 | — | |
Gilead Sciences, Inc. et al v. Amneal Pharmaceuticals LLC 2 patentsANDA 209721emtricitabine/tenofovir disoproxil fumarate | D. Del. | 2017-07-13 | Terminated 2018-06-08 | — |
Gilead Sciences, Inc. et al v. Mylan Inc. et al 3 patentsANDA 020636emtricitabine and tenofovir disoproxil fumarate | S.D.N.Y. | 2014-06-02 | Terminated 2014-06-27 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
AIDS Healthcare Foundation (AHF) - Citizen Petition FDA-2012-P-0607 · 3 docket documents The AIDS Healthcare Foundation filed this citizen petition under section 355(q) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA Commissioner not rely on the Antiviral Drugs Advisory Committee's May 10, 2012 recommendations regarding Gilead Sciences' supplemental New Drug Applicat | 505(q) | 2012-06-12 | Denied | — |
AIDS Healthcare Foundation - Citizen Petition FDA-2012-P-0226 · 3 docket documents The AIDS Healthcare Foundation filed this Section 505(q) citizen petition on March 5, 2012, requesting that the FDA deny Gilead Sciences' supplemental New Drug Application to approve once-daily Truvada (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis to reduce HIV transmiss | 505(q) | 2012-03-20 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$59.70
per ea
Lowest NADAC/Unit
$59.70
per ea
Brand NDCs
1
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 61958070101TRUVADA 200 MG-300 MG TABLET | $59.70 | EA | Brand | $0.4566 | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.