FDA Orange Book
Is there a generic for Rozlytrek?
Rozlytrek contains entrectinib. 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 Rozlytrek (entrectinib). The Orange Book shows its last listed patent expires July 18, 2038 and its last listed exclusivity ends October 20, 2030.
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Rozlytrek products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 100MG | Marketed (Rx) | None | 0 | None |
| capsule, oral | 200MG | Marketed (Rx) | None | 0 | None |
| pellets, oral | 50MG/PACKET | Marketed (Rx) | None | 0 | None |
NDA 212725, 218550, held by GENENTECH INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Rozlytrek patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9616059 | July 8, 2028 | Method of use | U-2618 | 212725 |
| 8673893 | July 8, 2028 | Method of use | U-2618 | 212725 |
| 9255087 | July 8, 2028 | Method of use | U-2618 | 212725 |
| 8673893 | July 8, 2028 | Method of use | U-2617 | 212725 |
| 9255087 | July 8, 2028 | Method of use | U-2617 | 212725 |
| 9029356 | July 8, 2028 | Drug substance, Drug product | None | 212725 |
| 9085558 | July 8, 2028 | Drug product | None | 212725 |
| 8299057 | March 10, 2032 | Drug substance, Drug product | None | 212725 |
| 9649306 | May 22, 2033 | Method of use | U-2618 | 212725 |
| 9649306 | May 22, 2033 | Method of use | U-2617 | 212725 |
| 9085565 | May 22, 2033 | Drug substance, Drug product | None | 212725 |
| 10231965 | February 17, 2035 | Method of use | U-2618 | 212725 |
| 10231965 | February 17, 2035 | Method of use | U-2617 | 212725 |
| 10561651 | February 19, 2035 | Method of use | U-2745 | 212725 |
| 10738037 | May 18, 2037 | Drug substance, Drug product | U-2946 | 212725 |
| 11091469 | May 18, 2037 | Method of use | U-2617 | 212725 |
| 11091469 | May 18, 2037 | Method of use | U-2618 | 212725 |
| 11253515 | July 18, 2038 | Drug product | None | 212725 |
| 10398693 | July 18, 2038 | Drug product | None | 212725 |
Rozlytrek exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-265 | Orphan drug exclusivity | August 15, 2026 | 212725 |
| ODE-313 | Orphan drug exclusivity | August 15, 2026 | 212725 |
| ODE* | See the Orange Book exclusivity code list | August 15, 2026 | 218550 |
| NPP | New patient population | October 20, 2026 | 212725 |
| NP | New product | October 20, 2026 | 218550 |
| ODE-448 | Orphan drug exclusivity | October 20, 2030 | 212725 |
Rozlytrek NDC codes
Questions
Is there a generic for Rozlytrek?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Rozlytrek (entrectinib). The Orange Book shows its last listed patent expires July 18, 2038 and its last listed exclusivity ends October 20, 2030.
What is the generic name for Rozlytrek?
The active ingredient in Rozlytrek is entrectinib, per the FDA Orange Book.
When does the Rozlytrek patent expire?
The last patent listed for Rozlytrek in the Orange Book expires July 18, 2038. 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.