FDA Orange Book · active-ingredient family
Fingolimod hydrochloride
Fingolimod hydrochloride: 1 brand, 19 generics; first approved Sep 21, 2010; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 19 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
1
Generics (ANDA)
19
Listed patents
3
Next patent expiry
Dec 25, 2027
in 1 yr 4 mo
Brand (NDA) products
Originator applications
- GILENYARLDNOVARTISNDA 02252720182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5MG BASE CAPSULE ORAL Rx AB EQ 0.25MG BASE CAPSULE ORAL Rx —
Generic (ANDA) products (19)
Abbreviated applications
- FINGOLIMOD HYDROCHLORIDEALEMBICANDA 2079742026
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5MG BASE CAPSULE ORAL Rx AB - FINGOLIMOD HYDROCHLORIDEAUROBINDO PHARMA LTDANDA 2079832024
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5MG BASE CAPSULE ORAL Rx AB - FINGOLIMOD HYDROCHLORIDEEZRA VENTURESANDA 2079452023
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5MG BASE CAPSULE ORAL Rx AB - FINGOLIMOD HYDROCHLORIDEBIONPHARMAANDA 2102522023
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5MG BASE CAPSULE ORAL Rx AB - FINGOLIMOD HYDROCHLORIDEPRINSTON INCANDA 2080032022
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5MG BASE CAPSULE ORAL Rx AB - FINGOLIMOD HYDROCHLORIDETEVA PHARMS USAANDA 2121522021
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.25MG BASE CAPSULE ORAL Discontinued — - FINGOLIMOD HYDROCHLORIDEHEC PHARM CO LTDANDA 2079392021
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5MG BASE CAPSULE ORAL Rx AB - FINGOLIMOD HYDROCHLORIDEDR REDDYSANDA 2080002021
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5MG BASE CAPSULE ORAL Rx AB - FINGOLIMOD HYDROCHLORIDEMYLANANDA 2080052021
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5MG BASE CAPSULE ORAL Discontinued — - FINGOLIMOD HYDROCHLORIDEALKEM LABS LTDANDA 2080042020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5MG BASE CAPSULE ORAL Rx AB - FINGOLIMOD HYDROCHLORIDEAPOTEXANDA 2079932020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5MG BASE CAPSULE ORAL Rx AB - FINGOLIMOD HYDROCHLORIDEACCORD HLTHCAREANDA 2079912020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5MG BASE CAPSULE ORAL Rx AB - FINGOLIMOD HYDROCHLORIDEZYDUS PHARMSANDA 2079942020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5MG BASE CAPSULE ORAL Rx AB - FINGOLIMOD HYDROCHLORIDETEVA PHARMS USAANDA 2080082020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5MG BASE CAPSULE ORAL Rx AB - FINGOLIMOD HYDROCHLORIDECHARTWELL RXANDA 2079712020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5MG BASE CAPSULE ORAL Discontinued — - FINGOLIMOD HYDROCHLORIDEGLENMARK PHARMS LTDANDA 2079852020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5MG BASE CAPSULE ORAL Rx AB - FINGOLIMOD HYDROCHLORIDEHETERO LABS LTD VANDA 2079332020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5MG BASE CAPSULE ORAL Rx AB - FINGOLIMOD HYDROCHLORIDEBIOCON LTDANDA 2079792019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5MG BASE CAPSULE ORAL Rx AB - FINGOLIMOD HYDROCHLORIDESUN PHARMANDA 2080142019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5MG BASE CAPSULE ORAL Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 10543179 | in 1 yr 4 mo | U-2719 | |
| 9592208 | in 5 yr 8 mo | ProductU-2315 | |
| 9592208*PED | in 6 yr 2 mo |
Approval history
FDA approval span
First approval
16 yr 2 mo ago
Most recent approval
4 mo ago
Approvals span 2010–2026 across 20 FDA applications.
Brand (NDA) 15%
Generic (ANDA) 1995%
Fingolimod 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.
