ceritinib · Novartis · NDA 205755, 211225
Zykadia
Earliest generic entry, as listed
13 Dec 2037
Blocked by patent: US 12357630. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 7 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12357630 | use U-3096 | 13 Dec 2037 |
| US 8703787 | use U-1179 | 2 Feb 2032 |
| US 9309229 | substance, product | 18 Jan 2032 |
| US 8039479 | substance, product | 29 Jun 2030 |
| US 7964592 | substance, product | 29 Apr 2028 |
| US 8377921 | use U-1179 | 20 Nov 2027 |
| US 8399450 | substance, product | 20 Nov 2027 |
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 · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 205755 · 001 · RLD · discontinued | capsule, oral | 150MG | 2 Feb 2032 |
| 211225 · 001 · RLD | tablet, oral | 150MG | 13 Dec 2037 |
Expired or delisted (1)
- US 7893074 · substance, product · 25 Apr 2026