TESTOSTERONE UNDECANOATE | N206089 | TOLMAR 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
$17.92
per ea
Lowest NADAC/Unit
$8.95
per ea
Brand NDCs
3
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 69087023712JATENZO 237 MG CAPSULE | $17.92 | EA | Brand | — | 2026-06-17 |
| 69087015812JATENZO 158 MG CAPSULE | $8.96 | EA | Brand | — | 2026-06-17 |
| 69087019812JATENZO 198 MG CAPSULE | $8.95 | 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 |
|---|---|---|---|---|---|---|
| 8241664 | Mar 29, 2029 | — | — | Yes | — | |
| 8492369 | Dec 20, 2030 | — | — | Yes | — | |
| 8778916 | Apr 12, 2030 | — | — | Yes | — | — |
| 10543219 | Apr 12, 2030 | — | — | — | — | |
| 10617696 | Apr 12, 2030 | — | Yes | Yes | — | — |
| 11179402 | Apr 14, 2026 | — | Yes | Yes | — | — |
| 11179403 | Apr 12, 2030 | — | — | — | — | |
| 11331325 | Jan 6, 2027 | — | — | — | — | |
| 11426416 | Apr 12, 2030 | — | — | — | — | |
| 11564933 | Apr 12, 2039 | — | — | — | — | |
| 12605391 | Apr 12, 2039 | — | — | — | — |