FDA Orange Book · active-ingredient family
Eliglustat tartrate
Eliglustat tartrate is approved as 1 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CERDELGA · NDA 205494
1
Brand (NDA)
6
Generics (ANDA)
5
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CERDELGARLD | GENZYME CORP | NDA 205494 | AB | Aug 19, 2014 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ELIGLUSTAT TARTRATE | CIPLA | ANDA 212369 | — | Dec 10, 2024 | |
| ELIGLUSTAT TARTRATE | APOTEX | ANDA 212425 | — | Jul 10, 2024 | |
| ELIGLUSTAT TARTRATE | UPSHER SMITH LABS | ANDA 212420 | AB | May 02, 2023 | |
| ELIGLUSTAT TARTRATE | DR REDDYS | ANDA 212449 | — | Aug 17, 2022 | |
| ELIGLUSTAT TARTRATE | TEVA PHARMS USA INC | ANDA 212474 | — | Dec 27, 2021 | |
| ELIGLUSTAT TARTRATE | AIZANT | ANDA 212463 | AB | Sep 08, 2021 |
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7196205 | Jun 26, 2026 | in 7 d | Substance |
| 11458119 | Nov 24, 2030 | in 4 yr 6 mo | SubstanceProduct |
| 10888547 | Jan 31, 2031 | in 4 yr 8 mo | U-3042 |
| 12465586 | Jun 05, 2032 | in 6 yr 1 mo | U-3042 |
| 10888544 | Dec 13, 2038 | in 12 yr 8 mo | U-3041 |
Eliglustat tartrate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
