FDA Orange Book · active-ingredient family
Armodafinil
Armodafinil is approved as 1 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:NUVIGIL · NDA 021875
1
Brand (NDA)
6
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NUVIGILRLD×5 | NUVO PHARMS | NDA 021875 | AB | Jun 15, 2007 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ARMODAFINIL×3 | COREPHARMA | ANDA 201514 | AB | Mar 25, 2019 | |
| ARMODAFINIL×4 | AUROBINDO PHARMA LTD | ANDA 206069 | AB | Mar 06, 2018 | |
| ARMODAFINIL×4 | LUPIN | ANDA 200751 | AB | Nov 28, 2016 | |
| ARMODAFINIL×5 | NATCO PHARMA LTD | ANDA 202768 | AB | Nov 28, 2016 | |
| ARMODAFINIL×2 | WATSON LABS INC | ANDA 200156 | — | Aug 29, 2012 | |
| ARMODAFINIL×5 | MYLAN PHARMS INC | ANDA 200043 | AB | Jun 01, 2012 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Armodafinil — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
