FDA Orange Book
Is there a generic for Augtyro?
Augtyro contains repotrectinib. 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 Augtyro (repotrectinib). The Orange Book shows its last listed patent expires July 24, 2036 and its last listed exclusivity ends June 13, 2031.
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Augtyro products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 160MG | Marketed (Rx) | None | 0 | None |
| capsule, oral | 40MG | Marketed (Rx) | None | 0 | None |
NDA 218213, held by BRISTOL MYERS SQUIBB CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Augtyro patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| RE50634 | January 23, 2035 | Drug substance, Drug product | None | 218213 |
| 10294242 | July 5, 2036 | Drug substance | None | 218213 |
| 12187739 | July 5, 2036 | Drug product | None | 218213 |
| 12310968 | July 20, 2036 | Method of use | U-3755 | 218213 |
| 11452725 | July 24, 2036 | Method of use | U-3961 | 218213 |
| 11452725 | July 24, 2036 | Method of use | U-3755 | 218213 |
Augtyro exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | November 15, 2028 | 218213 |
| ODE-455 | Orphan drug exclusivity | November 15, 2030 | 218213 |
| ODE* | See the Orange Book exclusivity code list | November 15, 2030 | 218213 |
| ODE-483 | Orphan drug exclusivity | June 13, 2031 | 218213 |
Augtyro NDC codes
Questions
Is there a generic for Augtyro?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Augtyro (repotrectinib). The Orange Book shows its last listed patent expires July 24, 2036 and its last listed exclusivity ends June 13, 2031.
What is the generic name for Augtyro?
The active ingredient in Augtyro is repotrectinib, per the FDA Orange Book.
When does the Augtyro patent expire?
The last patent listed for Augtyro in the Orange Book expires July 24, 2036. 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.