eliglustat tartrate · Genzyme Corp · NDA 205494
Cerdelga
Earliest generic entry, as listed
13 Dec 2038
Blocked by patent: US 10888544. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 4 unexpired
7 Orange Book listing rows for 4 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 10888544 | use U-3040, U-3041 | 13 Dec 2038 |
| US 10888544 listing row | use U-3040 · sets the listed date | 13 Dec 2038 |
| US 10888544 listing row | use U-3041 · sets the listed date | 13 Dec 2038 |
| US 12465586 | use U-3042, U-3043 | 5 Jun 2032 |
| US 12465586 listing row | use U-3042 | 5 Jun 2032 |
| US 12465586 listing row | use U-3043 | 5 Jun 2032 |
| US 10888547 | use U-3042, U-3043 | 31 Jan 2031 |
| US 10888547 listing row | use U-3042 | 31 Jan 2031 |
| US 10888547 listing row | use U-3043 | 31 Jan 2031 |
| US 11458119 | drug substance, drug product | 24 Nov 2030 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 205494 · 001 · RLD | capsule, oral | EQ 84MG BASE | 13 Dec 2038 |
Expired or delisted (1)
- US 7196205 · substance · 26 Jun 2026