FDA Orange Book · active-ingredient family
Eliglustat tartrate
Eliglustat tartrate: 1 brand, 6 generics; first approved Aug 19, 2014; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 6 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
1
Generics (ANDA)
6
Listed patents
5
Next patent expiry
Jun 26, 2026
2 mo ago
Brand (NDA) products
Originator applications
- GENZYME CORPNDA 2054942014
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 84MG BASE CAPSULE ORAL Rx AB
Generic (ANDA) products (6)
Abbreviated applications
- ELIGLUSTAT TARTRATECIPLAANDA 2123692024
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 84MG BASE CAPSULE ORAL Discontinued — - ELIGLUSTAT TARTRATEAPOTEXANDA 2124252024
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 84MG BASE CAPSULE ORAL Discontinued — - ELIGLUSTAT TARTRATEUPSHER SMITH LABSANDA 2124202023
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 84MG BASE CAPSULE ORAL Rx AB - ELIGLUSTAT TARTRATEDR REDDYSANDA 2124492022
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 84MG BASE CAPSULE ORAL Discontinued — - ELIGLUSTAT TARTRATETEVA PHARMS USA INCANDA 2124742021
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 84MG BASE CAPSULE ORAL Discontinued — - ELIGLUSTAT TARTRATEAIZANTANDA 2124632021
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 84MG BASE CAPSULE ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 7196205 | 2 mo ago | Substance | |
| 11458119 | in 4 yr 4 mo | SubstanceProduct | |
| 10888547 | in 4 yr 6 mo | U-3042 | |
| 12465586 | in 5 yr 11 mo | U-3042 | |
| 10888544 | in 12 yr 6 mo | U-3041 |
Approval history
FDA approval span
First approval
12 yr 2 mo ago
Most recent approval
1 yr 9 mo ago
Approvals span 2014–2024 across 7 FDA applications.
Brand (NDA) 114%
Generic (ANDA) 686%
Eliglustat tartrate: 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
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- 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.
