FDA Orange Book
Generic for Cerdelga
Cerdelga contains eliglustat. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Cerdelga is eliglustat. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Cerdelga products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 84MG BASE | Marketed (Rx) | AB | 2 | AB |
NDA 205494, held by GENZYME CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic eliglustat
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AIZANT DRUG RESEARCH SOLUTIONS PVT LTD | 212463 | AB (A-rated, therapeutically equivalent) | September 8, 2021 | EQ 84MG BASE |
| UPSHER SMITH LABORATORIES LLC | 212420 | AB (A-rated, therapeutically equivalent) | May 2, 2023 | EQ 84MG BASE |
Cerdelga patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7196205 | June 26, 2026 | Drug substance | None | 205494 |
| 11458119 | November 24, 2030 | Drug substance, Drug product | None | 205494 |
| 10888547 | January 31, 2031 | Method of use | U-3042 | 205494 |
| 10888547 | January 31, 2031 | Method of use | U-3043 | 205494 |
| 12465586 | June 5, 2032 | Method of use | U-3042 | 205494 |
| 12465586 | June 5, 2032 | Method of use | U-3043 | 205494 |
| 10888544 | December 13, 2038 | Method of use | U-3041 | 205494 |
| 10888544 | December 13, 2038 | Method of use | U-3040 | 205494 |
Cerdelga NDC codes
Questions
Is there a generic for Cerdelga?
Yes. The generic name for Cerdelga is eliglustat. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Cerdelga?
The active ingredient in Cerdelga is eliglustat, per the FDA Orange Book.
When does the Cerdelga patent expire?
The last patent listed for Cerdelga in the Orange Book expires December 13, 2038. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.