ARMODAFINIL | N021875 | NUVO PHARMACEUTICALS (IRELAND) DAC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2010-12-14 | Terminated 2013-03-30 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Public Citizen’s Health Research Group FDA-2025-P-1449 · 20 docket documents Public Citizen's Health Research Group filed this petition under the Federal Food, Drug, and Cosmetic Act sections 352 and 505(o)(4) requesting that the FDA contraindicate modafinil (PROVIGIL and generics) and armodafinil (NUVIGIL and generics) during pregnancy and in females of reproductive potenti | Other | 2025-05-29 | Open | Public Citizen’s Health Research Group |
Actavis, Inc. - Citizen Petition FDA-2010-P-0579 · 7 docket documents Actavis, Inc. filed this citizen petition on November 9, 2010, requesting that the FDA determine that Nuvigil (armodafinil) Tablets in 100 mg and 200 mg strengths, approved under NDA 21-875 and discontinued in February 2010, were not voluntarily withdrawn for safety or efficacy reasons, as required | 505(q) | 2010-11-22 | Granted | — |
Watson Laboratories, Inc. - Citizen Petition FDA-2010-P-0577 · 6 docket documents Watson Laboratories, Inc. filed this citizen petition on November 9, 2010, requesting that the FDA determine whether Cephalon, Inc.'s Nuvigil (armodafinil) tablets in 100 mg and 200 mg strengths (NDA 021875) were withdrawn from the market for safety or effectiveness reasons, and if not, to declare A | 505(q) | 2010-11-15 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$35.06
per ea
Lowest NADAC/Unit
$0.2871
per ea
Brand NDCs
5
Generic NDCs
7
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 63459022030NUVIGIL 200 MG TABLET | $35.06 | EA | Brand | $0.8238 | 2025-11-19 |
| 60505484903NUVIGIL 200 MG TABLET | $35.06 | EA | Brand | $0.8238 | 2025-11-19 |
| 60505484703NUVIGIL 150 MG TABLET | $34.75 | EA | Brand | $0.8003 | 2026-01-21 |
| 63459021530NUVIGIL 150 MG TABLET | $34.75 | EA | Brand | $0.8003 | 2026-01-21 |
| 60505485003NUVIGIL 250 MG TABLET | $34.74 | EA | Brand | $0.9472 | 2026-06-17 |
| 00781805331ARMODAFINIL 250 MG TABLET | $0.9472 | EA | Generic | — | 2026-06-17 |
Showing 6 of 12 NDCs.
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.