FDA Orange Book
Is there a generic for Vitrakvi?
Vitrakvi contains larotrectinib. 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 Vitrakvi (larotrectinib). The Orange Book shows its last listed patent expires May 16, 2037.
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Vitrakvi products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 100MG BASE | Marketed (Rx) | None | 0 | None |
| capsule, oral | EQ 25MG BASE | Marketed (Rx) | None | 0 | None |
| solution, oral | EQ 20MG BASE/ML | Marketed (Rx) | None | 0 | None |
NDA 210861, 211710, held by BAYER HEALTHCARE PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Vitrakvi patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10047097 | October 21, 2029 | Method of use | U-2474 | 210861 |
| 8865698 | October 21, 2029 | Method of use | U-2469 | 210861 |
| 10005783 | October 21, 2029 | Method of use | U-2472 | 210861 |
| 9447104 | October 21, 2029 | Method of use | U-2470 | 210861 |
| 9676783 | October 21, 2029 | Method of use | U-2469 | 210861 |
| 10774085 | October 21, 2029 | Method of use | U-2470 | 210861 |
| 9127013 | October 21, 2029 | Drug substance, Drug product | None | 210861 |
| 8513263 | December 23, 2029 | Drug substance, Drug product | None | 210861 |
| 9782414 | November 16, 2035 | Method of use | U-2475 | 210861 |
| 10285993 | November 16, 2035 | Method of use | U-2470 | 210861 |
| 10813936 | November 16, 2035 | Method of use | U-2987 | 210861 |
| 10172861 | November 16, 2035 | Drug substance, Drug product | None | 210861 |
| 9782414 | November 16, 2035 | Method of use | U-2471 | 211710 |
| 10799505 | August 15, 2036 | Drug substance, Drug product | None | 210861 |
| 10045991 | April 4, 2037 | Method of use | U-2473 | 211710 |
| 11484535 | April 4, 2037 | Method of use | U-2470 | 211710 |
| 11191766 | April 4, 2037 | Method of use | U-2471 | 211710 |
| 10668072 | April 4, 2037 | Drug product | None | 211710 |
| 10137127 | April 4, 2037 | Drug product | None | 211710 |
| 11974998 | May 16, 2037 | Method of use | U-4124 | 210861 |
| 11337967 | May 16, 2037 | Method of use | U-4123 | 210861 |
Vitrakvi NDC codes
Questions
Is there a generic for Vitrakvi?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Vitrakvi (larotrectinib). The Orange Book shows its last listed patent expires May 16, 2037.
What is the generic name for Vitrakvi?
The active ingredient in Vitrakvi is larotrectinib, per the FDA Orange Book.
When does the Vitrakvi patent expire?
The last patent listed for Vitrakvi in the Orange Book expires May 16, 2037. 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.