TESTOSTERONE UNDECANOATE | N208088 | VERITY PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Clarus Therapeutics, Inc. FDA-2019-P-4644 · 39 docket documents Clarus Therapeutics, Inc. filed this citizen petition under Sections 505(b), 505(j), and 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that FDA issue written guidance establishing clear safety and efficacy standards for oral testosterone-ester prodrugs as testosterone replacement the | 505(q) | 2019-10-09 | Denied | Clarus Therapeutics, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$7.18
per ea
Lowest NADAC/Unit
$7.18
per ea
Brand NDCs
1
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 74676011202TLANDO 112.5 MG CAPSULE | $7.18 | 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 |
|---|---|---|---|---|---|---|
| 8778922 | Jan 8, 2029 | — | — | Yes | — | |
| 8865695 | Jan 8, 2029 | — | — | — | — | |
| 9943527 | Nov 30, 2030 | — | — | — | — | |
| 9949985 | Nov 30, 2030 | — | — | — | — | |
| 10226473 | Nov 30, 2030 | — | — | — | — | |
| 10716794 | Nov 30, 2030 | — | — | — | — | |
| 11304960 | Jan 8, 2029 | — | — | Yes | — | |
| 11311555 | Nov 30, 2030 | — | — | — | — | |
| 11364249 | Nov 30, 2030 | — | — | — | — | |
| 11433083 | Nov 30, 2030 | — | — | — | — | |
| 11464735 | Apr 28, 2041 | — | — | Yes | — | |
| 11559530 | Nov 28, 2037 | — | — | — | — | |
| 12011503 | Oct 16, 2040 | — | — | Yes | — | |
| 12310978 | Feb 21, 2039 | — | — | — | — |