FDA Orange Book
Is there a generic for Tibsovo?
Tibsovo contains ivosidenib. 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
No. The Orange Book lists no active FDA-approved generic (ANDA) for Tibsovo (ivosidenib). The Orange Book shows its last listed patent expires June 7, 2039 and its last listed exclusivity ends October 24, 2030.
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Tibsovo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 250MG | Marketed (Rx) | None | 0 | None |
NDA 211192, held by SERVIER PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Tibsovo patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10610125 | June 21, 2030 | Method of use | U-2784 | 211192 |
| 10610125 | June 21, 2030 | Method of use | U-2785 | 211192 |
| 10610125 | June 21, 2030 | Method of use | U-3385 | 211192 |
| 9850277 | January 18, 2033 | Drug substance, Drug product | U-2534 | 211192 |
| 9850277 | January 18, 2033 | Drug substance, Drug product | U-2350 | 211192 |
| 9850277 | January 18, 2033 | Drug substance, Drug product | U-2533 | 211192 |
| 9850277 | January 18, 2033 | Drug substance, Drug product | U-3742 | 211192 |
| 10717764 | January 18, 2033 | Method of use | U-3215 | 211192 |
| 11667673 | January 18, 2033 | Method of use | U-3742 | 211192 |
| 9850277 | January 18, 2033 | Drug substance, Drug product | U-3386 | 211192 |
| 9850277 | January 18, 2033 | Drug substance, Drug product | U-3213 | 211192 |
| 9474779 | August 19, 2033 | Drug substance, Drug product | U-2534 | 211192 |
| 9474779 | August 19, 2033 | Drug substance, Drug product | U-2533 | 211192 |
| 9474779 | August 19, 2033 | Drug substance, Drug product | U-2350 | 211192 |
| 9474779 | August 19, 2033 | Drug substance, Drug product | U-3742 | 211192 |
| 9474779 | August 19, 2033 | Drug substance, Drug product | U-3386 | 211192 |
| 9474779 | August 19, 2033 | Drug substance, Drug product | U-3213 | 211192 |
| 9968595 | March 13, 2035 | Drug product | U-2534 | 211192 |
| 9968595 | March 13, 2035 | Drug product | U-2533 | 211192 |
| 9968595 | March 13, 2035 | Drug product | U-2351 | 211192 |
| 10799490 | March 13, 2035 | Drug product | U-3384 | 211192 |
| 9968595 | March 13, 2035 | Drug product | U-3384 | 211192 |
| 10799490 | March 13, 2035 | Drug product | U-2981 | 211192 |
| 10799490 | March 13, 2035 | Drug product | U-2982 | 211192 |
| 10449184 | March 13, 2035 | Drug product | None | 211192 |
| 10653710 | October 18, 2036 | Method of use | U-3387 | 211192 |
| 10980788 | June 7, 2039 | Method of use | U-3214 | 211192 |
| 10980788 | June 7, 2039 | Method of use | U-3743 | 211192 |
| 10980788 | June 7, 2039 | Method of use | U-3383 | 211192 |
| 10980788 | June 7, 2039 | Method of use | U-3112 | 211192 |
| 10980788 | June 7, 2039 | Method of use | U-3113 | 211192 |
Tibsovo exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-242 | Orphan drug exclusivity | May 2, 2026 | 211192 |
| I-924 | New indication | October 24, 2026 | 211192 |
| ODE-368 | Orphan drug exclusivity | August 25, 2028 | 211192 |
| ODE-447 | Orphan drug exclusivity | October 24, 2030 | 211192 |
Tibsovo NDC codes
Questions
Is there a generic for Tibsovo?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Tibsovo (ivosidenib). The Orange Book shows its last listed patent expires June 7, 2039 and its last listed exclusivity ends October 24, 2030.
What is the generic name for Tibsovo?
The active ingredient in Tibsovo is ivosidenib, per the FDA Orange Book.
When does the Tibsovo patent expire?
The last patent listed for Tibsovo in the Orange Book expires June 7, 2039. 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.