ivosidenib · Servier · NDA 211192
Tibsovo
Earliest generic entry, as listed
7 Jun 2039
Blocked by patent: US 10980788. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 10 unexpired
31 Orange Book listing rows for 10 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 10980788 | use U-3112, U-3113, U-3214, U-3383, U-3743 | 7 Jun 2039 |
| US 10980788 listing row | use U-3112 · sets the listed date | 7 Jun 2039 |
| US 10980788 listing row | use U-3113 · sets the listed date | 7 Jun 2039 |
| US 10980788 listing row | use U-3214 · sets the listed date | 7 Jun 2039 |
| US 10980788 listing row | use U-3383 · sets the listed date | 7 Jun 2039 |
| US 10980788 listing row | use U-3743 · sets the listed date | 7 Jun 2039 |
| US 10653710 | use U-3387 | 18 Oct 2036 |
| US 10449184 | drug product | 13 Mar 2035 |
| US 10799490 | drug product, use U-2981, U-2982, U-3384 | 13 Mar 2035 |
| US 10799490 listing row | drug product, use U-2981 | 13 Mar 2035 |
| US 10799490 listing row | drug product, use U-2982 | 13 Mar 2035 |
| US 10799490 listing row | drug product, use U-3384 | 13 Mar 2035 |
| US 9968595 | drug product, use U-2351, U-2533, U-2534, U-3384 | 13 Mar 2035 |
| US 9968595 listing row | drug product, use U-2351 | 13 Mar 2035 |
| US 9968595 listing row | drug product, use U-2533 | 13 Mar 2035 |
| US 9968595 listing row | drug product, use U-2534 | 13 Mar 2035 |
| US 9968595 listing row | drug product, use U-3384 | 13 Mar 2035 |
| US 9474779 | drug substance, drug product, use U-2350, U-2533, U-2534, U-3213, U-3386, U-3742 | 19 Aug 2033 |
| US 9474779 listing row | drug substance, drug product, use U-2350 | 19 Aug 2033 |
| US 9474779 listing row | drug substance, drug product, use U-2533 | 19 Aug 2033 |
| US 9474779 listing row | drug substance, drug product, use U-2534 | 19 Aug 2033 |
| US 9474779 listing row | drug substance, drug product, use U-3213 | 19 Aug 2033 |
| US 9474779 listing row | drug substance, drug product, use U-3386 | 19 Aug 2033 |
| US 9474779 listing row | drug substance, drug product, use U-3742 | 19 Aug 2033 |
| US 10717764 | use U-3215 | 18 Jan 2033 |
| US 11667673 | use U-3742 | 18 Jan 2033 |
| US 9850277 | drug substance, drug product, use U-2350, U-2533, U-2534, U-3213, U-3386, U-3742 | 18 Jan 2033 |
| US 9850277 listing row | drug substance, drug product, use U-2350 | 18 Jan 2033 |
| US 9850277 listing row | drug substance, drug product, use U-2533 | 18 Jan 2033 |
| US 9850277 listing row | drug substance, drug product, use U-2534 | 18 Jan 2033 |
| US 9850277 listing row | drug substance, drug product, use U-3213 | 18 Jan 2033 |
| US 9850277 listing row | drug substance, drug product, use U-3386 | 18 Jan 2033 |
| US 9850277 listing row | drug substance, drug product, use U-3742 | 18 Jan 2033 |
| US 10610125 | use U-2784, U-2785, U-3385 | 21 Jun 2030 |
| US 10610125 listing row | use U-2784 | 21 Jun 2030 |
| US 10610125 listing row | use U-2785 | 21 Jun 2030 |
| US 10610125 listing row | use U-3385 | 21 Jun 2030 |
Exclusivities · 2 unexpired
| ODE-447 | orphan drug (7 years) | 24 Oct 2030 |
| ODE-368 | orphan drug (7 years) | 25 Aug 2028 |
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
- Exclusivity expires within 90 days I-924 · 211192-001Exclusivity expires 24 Oct 2026Detected 24 Oct 2026
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 211192 · 001 · RLD | tablet, oral | 250MG | 7 Jun 2039 |
Expired or delisted (2)
- I-924 · 24 Oct 2026
- ODE-242 · 2 May 2026