cedazuridine; decitabine · Taiho Oncology · NDA 212576
Inqovi
Earliest generic entry, as listed
10 Dec 2042
Blocked by patent: US 12697347. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 7 unexpired
12 Orange Book listing rows for 7 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 12697347 | use U-4587 · sets the listed date | 10 Dec 2042 |
| US 11963971 | drug product | 24 Feb 2041 |
| US 12239653 | use U-2865, U-2866 | 24 Feb 2041 |
| US 12239653 listing row | use U-2865 | 24 Feb 2041 |
| US 12239653 listing row | use U-2866 | 24 Feb 2041 |
| US 12195496 | drug product | 7 Oct 2040 |
| US 8268800 | drug substance, use U-2864, U-2865, U-2866, U-2867 | 12 Feb 2034 |
| US 8268800 listing row | drug substance, use U-2864 | 12 Feb 2034 |
| US 8268800 listing row | drug substance, use U-2865 | 12 Feb 2034 |
| US 8268800 listing row | drug substance, use U-2866 | 12 Feb 2034 |
| US 8268800 listing row | drug substance, use U-2867 | 12 Feb 2034 |
| US 8618075 | use U-2864, U-2867 | 16 Oct 2028 |
| US 8618075 listing row | use U-2864 | 16 Oct 2028 |
| US 8618075 listing row | use U-2867 | 16 Oct 2028 |
| US 9567363 | drug substance | 16 Oct 2028 |
Exclusivities · 2 unexpired
| I-990 | new indication (3 years) | 13 May 2029 |
| ODE-316 | orphan drug (7 years) | 7 Jul 2027 |
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 |
|---|---|---|---|
| 212576 · 001 · RLD | tablet, oral | 100MG;35MG | 10 Dec 2042 |