FDA Orange Book · active-ingredient family
Almotriptan malate
Almotriptan malate: 1 brand, 3 generics; first approved May 07, 2001; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 3 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
3
Listed patents
0
Presentations
8
Brand (NDA) products
Originator applications
- AXERTRLDJANSSEN PHARMSNDA 02100120012 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 6.25MG BASE TABLET ORAL Discontinued — EQ 12.5MG BASE TABLET ORAL Discontinued —
Generic (ANDA) products (3)
Abbreviated applications
- ALMOTRIPTAN MALATEAJANTA PHARMA LTDANDA 20552320162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 6.25MG BASE TABLET ORAL Rx AB EQ 12.5MG BASE TABLET ORAL Rx AB - ALMOTRIPTAN MALATEMYLANANDA 20517120152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 6.25MG BASE TABLET ORAL Rx AB EQ 12.5MG BASE TABLET ORAL Rx AB - ALMOTRIPTAN MALATETEVA PHARMS USAANDA 07802720152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 6.25MG BASE TABLET ORAL Rx AB EQ 12.5MG BASE 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
25 yr 8 mo ago
Most recent approval
10 yr 7 mo ago
Approvals span 2001–2016 across 4 FDA applications.
Brand (NDA) 125%
Generic (ANDA) 375%
Almotriptan malate: 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.
