TADALAFIL | N214522 | CMP DEVELOPMENT LLC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D.N.J. | 2026-03-16 | Active | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Lachman Consultant Services, Inc. - Citizen Petition FDA-2012-P-0935 · 3 docket documents Lachman Consultant Services, Inc. filed this petition on behalf of a client under Section 505(j)(2)(C) requesting that the FDA declare Tadalafil Tablets, 40 mg suitable for submission as an ANDA, with ADCIRCA (Tadalafil Tablets, 20 mg, NDA 22-332) as the reference-listed drug, seeking approval for a | Other | 2012-09-18 | WithdrawnUnverified summary | — |
Citizens Petition from Public Citizen's Health Research Group FDA-2005-P-0192 · 5 docket documents Public Citizen filed this citizen petition pursuant to 21 U.S.C. Section 355(e)(3) and 21 C.F.R. 10.30 requesting that the FDA immediately add black box warnings to the three phosphodiesterase-5 inhibitors Viagra (sildenafil), Cialis (tadalafil), and Levitra (vardenafil), as well as to Revatio (sild | Other | 2005-10-20 | DeniedUnverified summary | Public Citizen's Health Research Group |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$13.07
per ml
Lowest NADAC/Unit
$13.07
per ml
Brand NDCs
1
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 46287004515TADLIQ 20 MG/5 ML SUSPENSION | $13.07 | ML | Brand | — | 2026-08-19 |
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 |
|---|---|---|---|---|---|---|
| 11382917 | Dec 24, 2038 | — | — | Yes | — | |
| 11666576 | Dec 24, 2038 | — | — | Yes | — | |
| 11975006 | Dec 24, 2038 | — | — | Yes | — | |
| 12186322 | Dec 24, 2038 | — | — | Yes | — | |
| 12691120Newly listed — daily FDA feed, not yet in monthly Orange Book edition | Dec 24, 2038 | — | — | Yes | — | |
| 12697338Newly listed — daily FDA feed, not yet in monthly Orange Book edition | Dec 24, 2038 | — | — | Yes | — | |
| 12708626Newly listed — daily FDA feed, not yet in monthly Orange Book edition | Dec 24, 2038 | — | — | Yes | — |