FDA Orange Book
Is there a generic for Retevmo?
Retevmo contains selpercatinib. 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 Retevmo (selpercatinib). The Orange Book shows its last listed patent expires April 10, 2039 and its last listed exclusivity ends November 29, 2031.
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Retevmo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 40MG | Marketed (Rx) | None | 0 | None |
| capsule, oral | 80MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 120MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 160MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 40MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 80MG | Marketed (Rx) | None | 0 | None |
NDA 213246, 218160, held by ELI LILLY AND CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Retevmo patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10172851 | October 10, 2037 | Method of use | U-3450 | 213246 |
| 10137124 | October 10, 2037 | Method of use | U-3450 | 213246 |
| 10137124 | October 10, 2037 | Method of use | U-3949 | 213246 |
| 10137124 | October 10, 2037 | Method of use | U-3950 | 213246 |
| 10137124 | October 10, 2037 | Method of use | U-3951 | 213246 |
| 10172851 | October 10, 2037 | Method of use | U-3949 | 213246 |
| 10172851 | October 10, 2037 | Method of use | U-3950 | 213246 |
| 10172851 | October 10, 2037 | Method of use | U-3951 | 213246 |
| 10112942 | October 10, 2037 | Drug substance, Drug product | None | 213246 |
| 10112942*PED | April 10, 2038 | Method of use | None | 213246 |
| 10137124*PED | April 10, 2038 | Method of use | None | 213246 |
| 10172851*PED | April 10, 2038 | Method of use | None | 213246 |
| 12138250 | October 10, 2038 | Method of use | U-3949 | 213246 |
| 12138250 | October 10, 2038 | Method of use | U-3951 | 213246 |
| 12138250 | October 10, 2038 | Method of use | U-3950 | 213246 |
| 12138250 | October 10, 2038 | Method of use | U-3450 | 213246 |
| 10584124 | October 10, 2038 | Drug substance | U-3450 | 213246 |
| 10786489 | October 10, 2038 | Drug product | U-3450 | 213246 |
| 10584124 | October 10, 2038 | Drug substance | U-3949 | 213246 |
| 10584124 | October 10, 2038 | Drug substance | U-3950 | 213246 |
| 10584124 | October 10, 2038 | Drug substance | U-3951 | 213246 |
| 10786489 | October 10, 2038 | Drug product | U-3949 | 213246 |
| 10786489 | October 10, 2038 | Drug product | U-3951 | 213246 |
| 10786489 | October 10, 2038 | Drug product | U-3950 | 213246 |
| 12138250*PED | April 10, 2039 | Method of use | None | 213246 |
| 10786489*PED | April 10, 2039 | Method of use | None | 213246 |
| 10584124*PED | April 10, 2039 | Method of use | None | 213246 |
Retevmo exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-301 | Orphan drug exclusivity | May 8, 2027 | 213246 |
| ODE-302 | Orphan drug exclusivity | May 8, 2027 | 213246 |
| ODE-303 | Orphan drug exclusivity | May 8, 2027 | 213246 |
| ODE* | See the Orange Book exclusivity code list | May 8, 2027 | 218160 |
| NPP | New patient population | May 29, 2027 | 213246 |
| M-311 | Miscellaneous | September 27, 2027 | 213246 |
| M-312 | Miscellaneous | September 27, 2027 | 213246 |
| PED | Pediatric exclusivity | November 8, 2027 | 213246 |
| PED | Pediatric exclusivity | November 29, 2027 | 213246 |
| PED | Pediatric exclusivity | March 27, 2028 | 213246 |
| ODE-409 | Orphan drug exclusivity | September 21, 2029 | 213246 |
| ODE-412 | Orphan drug exclusivity | September 21, 2029 | 213246 |
| ODE* | See the Orange Book exclusivity code list | September 21, 2029 | 218160 |
| PED | Pediatric exclusivity | March 21, 2030 | 213246 |
| ODE-484 | Orphan drug exclusivity | May 29, 2031 | 213246 |
| ODE-485 | Orphan drug exclusivity | May 29, 2031 | 213246 |
| ODE-487 | Orphan drug exclusivity | May 29, 2031 | 213246 |
| ODE* | See the Orange Book exclusivity code list | May 29, 2031 | 218160 |
| PED | Pediatric exclusivity | November 29, 2031 | 213246 |
Retevmo NDC codes
Questions
Is there a generic for Retevmo?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Retevmo (selpercatinib). The Orange Book shows its last listed patent expires April 10, 2039 and its last listed exclusivity ends November 29, 2031.
What is the generic name for Retevmo?
The active ingredient in Retevmo is selpercatinib, per the FDA Orange Book.
When does the Retevmo patent expire?
The last patent listed for Retevmo in the Orange Book expires April 10, 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.