FDA Orange Book · active-ingredient family
Modafinil
Modafinil is approved as 1 brand and 9 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:PROVIGIL · NDA 020717
1
Brand (NDA)
9
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PROVIGILRLD×2 | NUVO PHARMS | NDA 020717 | AB | Dec 24, 1998 |
Generic (ANDA) products (9)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MODAFINIL×2 | CADILA | ANDA 209966 | AB | Sep 14, 2017 | |
| MODAFINIL×2 | APPCO | ANDA 207196 | AB | Aug 16, 2017 | |
| MODAFINIL×2 | APOTEX | ANDA 077667 | AB | Feb 03, 2014 | |
| MODAFINIL×2 | WATSON LABS INC | ANDA 076715 | — | Nov 01, 2012 | |
| MODAFINIL×2 | ALEMBIC | ANDA 202700 | AB | Oct 18, 2012 | |
| MODAFINIL×2 | AUROBINDO PHARMA LTD | ANDA 202566 | AB | Sep 27, 2012 | |
| MODAFINIL×2 | HIKMA PHARMS | ANDA 090543 | — | Sep 26, 2012 | |
| MODAFINIL×2 | ORBION PHARMS | ANDA 078963 | AB | Sep 26, 2012 | |
| MODAFINIL×2 | NATCO PHARMA | ANDA 076594 | — | Jul 16, 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.
Modafinil — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
