TESTOSTERONE | N021454 | ENDO OPERATIONS LTD
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Auxilium Pharmaceuticals Inc. et al v. Upsher-Smith Laboratories Inc. 10 patentsANDA 079178testosterone | D. Del. | 2013-01-28 | Terminated 2013-12-30 | — |
UPSHER-SMITH LABORATORIES, INC. v. AUXILIUM PHARMACEUTICALS, INC. et al 10 patentsANDA 79178testosterone | D.N.J. | 2012-09-10 | Terminated 2013-03-27 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Auxilium Pharmaceuticals, Inc. - Citizen Petition FDA-2013-P-0371 · 5 docket documents Auxilium Pharmaceuticals, Inc. filed this citizen petition on March 26, 2013 under section 505(b)(2) regarding Upsher-Smith Laboratories' testosterone transdermal gel 1% application (No. 204399) citing Auxilium's Testim as the reference listed drug, requesting that FDA refrain from assigning an "A" | 505(q) | 2013-04-16 | Partially Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$3.78
per gm
Lowest NADAC/Unit
$3.78
per gm
Brand NDCs
1
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 66887000105TESTIM 1% (50 MG) GEL | $3.78 | GM | Brand | $0.6918 | 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.