FDA Orange Book · active-ingredient family
Dalfampridine
Dalfampridine: 1 brand, 8 generics; first approved Jan 22, 2010; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 8 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
8
Listed patents
0
Presentations
9
Brand (NDA) products
Originator applications
- MERZNDA 0222502010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET, EXTENDED RELEASE ORAL Rx AB
Generic (ANDA) products (8)
Abbreviated applications
- DALFAMPRIDINERISINGANDA 2068582020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET, EXTENDED RELEASE ORAL Discontinued — - DALFAMPRIDINESUN PHARMANDA 2082922019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET, EXTENDED RELEASE ORAL Discontinued — - DALFAMPRIDINEMICRO LABSANDA 2101582019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET, EXTENDED RELEASE ORAL Rx AB - DALFAMPRIDINEHIKMAANDA 2066462018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET, EXTENDED RELEASE ORAL Discontinued — - DALFAMPRIDINEALKEM LABS LTDANDA 2067652018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET, EXTENDED RELEASE ORAL Rx AB - DALFAMPRIDINEACCORD HLTHCAREANDA 2068632018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET, EXTENDED RELEASE ORAL Rx AB - DALFAMPRIDINEACTAVIS LABS FL INCANDA 2068362017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET, EXTENDED RELEASE ORAL Rx AB - DALFAMPRIDINEAUROBINDO PHARMAANDA 2068112017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET, EXTENDED RELEASE 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
16 yr 10 mo ago
Most recent approval
6 yr 2 mo ago
Approvals span 2010–2020 across 9 FDA applications.
Brand (NDA) 111%
Generic (ANDA) 889%
Dalfampridine: 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.
