FDA Orange Book · active-ingredient family
Modafinil
Modafinil: 1 brand, 10 generics; first approved Dec 24, 1998; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 10 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
10
Listed patents
0
Presentations
22
Brand (NDA) products
Originator applications
- PROVIGILRLDNUVO PHARMSNDA 02071719982 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB
Generic (ANDA) products (10)
Abbreviated applications
- MODAFINILLUPINANDA 20834320262 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB - MODAFINILCADILAANDA 20996620172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB - MODAFINILAPPCOANDA 20719620172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB - MODAFINILAPOTEXANDA 07766720142 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB - MODAFINILWATSON LABS INCANDA 07671520122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — 200MG TABLET ORAL Discontinued — - MODAFINILALEMBICANDA 20270020122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB - MODAFINILAUROBINDO PHARMA LTDANDA 20256620122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB - MODAFINILHIKMA PHARMSANDA 09054320122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — 200MG TABLET ORAL Discontinued — - MODAFINILORBION PHARMSANDA 07896320122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB - MODAFINILNATCO PHARMAANDA 07659420122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — 200MG TABLET ORAL Discontinued —
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
28 yr 2 mo ago
Most recent approval
19 d ago
Approvals span 1998–2026 across 11 FDA applications.
Brand (NDA) 19%
Generic (ANDA) 1091%
Modafinil: 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.
