FDA Orange Book · active-ingredient family
Armodafinil
Armodafinil: 1 brand, 6 generics; first approved Jun 15, 2007; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 6 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
6
Listed patents
0
Presentations
28
Brand (NDA) products
Originator applications
- NUVIGILRLDNUVO PHARMSNDA 02187520075 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Discontinued — 150MG TABLET ORAL Rx AB 250MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB
Generic (ANDA) products (6)
Abbreviated applications
- ARMODAFINILCOREPHARMAANDA 20151420193 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB 250MG TABLET ORAL Rx AB - ARMODAFINILAUROBINDO PHARMA LTDANDA 20606920184 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB 250MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB - ARMODAFINILLUPINANDA 20075120164 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — 150MG TABLET ORAL Discontinued — 200MG TABLET ORAL Discontinued — 250MG TABLET ORAL Discontinued — - ARMODAFINILNATCO PHARMA LTDANDA 20276820165 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB 250MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB - ARMODAFINILWATSON LABS INCANDA 20015620122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — 200MG TABLET ORAL Discontinued — - ARMODAFINILMYLAN PHARMS INCANDA 20004320125 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB 250MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
19 yr 6 mo ago
Most recent approval
7 yr 5 mo ago
Approvals span 2007–2019 across 7 FDA applications.
Brand (NDA) 114%
Generic (ANDA) 686%
Armodafinil: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
