FDA Orange Book · active-ingredient family
Fingolimod hydrochloride
Fingolimod hydrochloride is approved as 1 brand and 19 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:GILENYA · NDA 022527
1
Brand (NDA)
19
Generics (ANDA)
3
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| GILENYARLD×2 | NOVARTIS | NDA 022527 | — | May 11, 2018 |
Generic (ANDA) products (19)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FINGOLIMOD HYDROCHLORIDE | ALEMBIC | ANDA 207974 | AB | Apr 24, 2026 | |
| FINGOLIMOD HYDROCHLORIDE | AUROBINDO PHARMA LTD | ANDA 207983 | AB | Feb 28, 2024 | |
| FINGOLIMOD HYDROCHLORIDE | EZRA VENTURES | ANDA 207945 | AB | Dec 06, 2023 | |
| FINGOLIMOD HYDROCHLORIDE | BIONPHARMA | ANDA 210252 | AB | May 24, 2023 | |
| FINGOLIMOD HYDROCHLORIDE | PRINSTON INC | ANDA 208003 | AB | Sep 07, 2022 | |
| FINGOLIMOD HYDROCHLORIDE | TEVA PHARMS USA | ANDA 212152 | — | Nov 12, 2021 | |
| FINGOLIMOD HYDROCHLORIDE | HEC PHARM CO LTD | ANDA 207939 | AB | Nov 10, 2021 | |
| FINGOLIMOD HYDROCHLORIDE | DR REDDYS | ANDA 208000 | AB | Mar 05, 2021 | |
| FINGOLIMOD HYDROCHLORIDE | MYLAN | ANDA 208005 | — | Jan 19, 2021 | |
| FINGOLIMOD HYDROCHLORIDE | ALKEM LABS LTD | ANDA 208004 | AB | Dec 30, 2020 | |
| FINGOLIMOD HYDROCHLORIDE | APOTEX | ANDA 207993 | AB | Dec 18, 2020 | |
| FINGOLIMOD HYDROCHLORIDE | ACCORD HLTHCARE | ANDA 207991 | AB | Oct 28, 2020 | |
| FINGOLIMOD HYDROCHLORIDE | ZYDUS PHARMS | ANDA 207994 | AB | Oct 14, 2020 | |
| FINGOLIMOD HYDROCHLORIDE | TEVA PHARMS USA | ANDA 208008 | AB | Jul 02, 2020 | |
| FINGOLIMOD HYDROCHLORIDE | CHARTWELL RX | ANDA 207971 | — | Jun 29, 2020 | |
| FINGOLIMOD HYDROCHLORIDE | GLENMARK PHARMS LTD | ANDA 207985 | AB | Jun 18, 2020 | |
| FINGOLIMOD HYDROCHLORIDE | HETERO LABS LTD V | ANDA 207933 | AB | May 18, 2020 | |
| FINGOLIMOD HYDROCHLORIDE | BIOCON LTD | ANDA 207979 | AB | Dec 04, 2019 | |
| FINGOLIMOD HYDROCHLORIDE | SUN PHARM | ANDA 208014 | — | Dec 04, 2019 |
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10543179 | Dec 25, 2027 | in 1 yr 6 mo | U-2719 |
| 9592208 | Mar 30, 2032 | in 5 yr 10 mo | ProductU-2315 |
| 9592208*PED | Sep 30, 2032 | in 6 yr 5 mo |
Fingolimod hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
