SILDENAFIL CITRATE | N020895 | VIATRIS SPECIALTY LLC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2018-02-01 | Terminated 2018-04-18 | — | |
| D. Del. | 2017-10-31 | Terminated 2018-05-31 | — | |
| D. Del. | 2017-06-06 | Terminated 2017-08-16 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Pharma Regulatory Consultants LLC FDA-2018-P-1174 · 6 docket documents Pharma Regulatory Consultants LLC filed this citizen petition on March 10, 2018, requesting that the FDA declare Sildenafil Citrate Oral Suspension, 10 mg/mL suitable for submission as an abbreviated new drug application under Section 505(j)(2)(C), with the reference-listed drug being Revatio (Silde | Other | 2018-03-16 | Denied | Pharma Regulatory Consultants LLC |
Citizen Petition from Pharmacists Planning Service Inc FDA-2014-P-1569 · 3 docket documents Pharmacists Planning Service, Inc., a nonprofit public health organization, filed this citizen petition under 21 CFR 10.20 and 10.30 requesting that the FDA Commissioner issue a federal regulation to reclassify Viagra (sildenafil citrate) from prescription-only status to a dual category allowing it | Other | 2014-10-10 | Denied | Pharmacists Planning Service Inc |
Kleinfeld Kaplan and Becker LLP - Citizen Petition FDA-2009-P-0235 · 3 docket documents Kleinfeld Kaplan and Becker LLP filed this citizen petition requesting that the FDA deny any new drug application or supplemental new drug application under Section 505(b)(1) for Pfizer's proposed intravenous formulation of sildenafil citrate (sildenafil IV) unless the application includes substanti | 505(q) | 2009-05-27 | Partially Denied | — |
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 | Denied | Public Citizen's Health Research Group |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$83.65
per ea
Lowest NADAC/Unit
$0.1038
per ea
Brand NDCs
4
Generic NDCs
4
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00069422030VIAGRA 100 MG TABLET | $83.65 | EA | Brand | $0.1298 | 2026-06-17 |
| 00069422066VIAGRA 100 MG TABLET | $83.65 | EA | Brand | $0.1298 | 2026-06-17 |
| 58151042801VIAGRA 100 MG TABLET | $83.65 | EA | Brand | $0.1298 | 2026-06-17 |
| 58151042893VIAGRA 100 MG TABLET | $83.65 | EA | Brand | $0.1298 | 2026-06-17 |
| 59762003602SILDENAFIL 100 MG TABLET | $0.1298 | EA | Generic | — | 2026-06-17 |
| 59762003401SILDENAFIL 25 MG TABLET | $0.1163 | EA | Generic | — | 2026-06-17 |
| 59762003501SILDENAFIL 50 MG TABLET | $0.1038 | EA | Generic | — | 2026-06-17 |
| 59762003502SILDENAFIL 50 MG TABLET | $0.1038 | EA | Generic | — | 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.