FDA Orange Book · active-ingredient family
Alosetron hydrochloride
Alosetron hydrochloride: 1 brand, 6 generics; first approved Feb 09, 2000; 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
14
Brand (NDA) products
Originator applications
- LOTRONEXRLDLEGACYNDA 02110720032 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE TABLET ORAL Rx AB EQ 0.5MG BASE TABLET ORAL Rx AB
Generic (ANDA) products (6)
Abbreviated applications
- ALOSETRON HYDROCHLORIDEMANKIND PHARMAANDA 21361420202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5MG BASE TABLET ORAL Rx AB EQ 1MG BASE TABLET ORAL Rx AB - ALOSETRON HYDROCHLORIDEHIBROW HLTHCAREANDA 21162120192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5MG BASE TABLET ORAL Rx AB EQ 1MG BASE TABLET ORAL Rx AB - ALOSETRON HYDROCHLORIDERISINGANDA 20918020192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5MG BASE TABLET ORAL Rx AB EQ 1MG BASE TABLET ORAL Rx AB - ALOSETRON HYDROCHLORIDEPH HEALTHANDA 20611320182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5MG BASE TABLET ORAL Discontinued — EQ 1MG BASE TABLET ORAL Discontinued — - ALOSETRON HYDROCHLORIDEAMNEAL PHARMSANDA 20664720162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5MG BASE TABLET ORAL Rx AB EQ 1MG BASE TABLET ORAL Rx AB - ALOSETRON HYDROCHLORIDEHIKMAANDA 20065220152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5MG BASE TABLET ORAL Discontinued — EQ 1MG BASE 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
26 yr 11 mo ago
Most recent approval
6 yr 1 mo ago
Approvals span 2000–2020 across 7 FDA applications.
Brand (NDA) 114%
Generic (ANDA) 686%
Alosetron hydrochloride: 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.
