FDA Orange Book
Is there a generic for Tepmetko?
Tepmetko contains tepotinib. 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 Tepmetko (tepotinib). The Orange Book shows its last listed patent expires March 19, 2030 and its last listed exclusivity ends February 3, 2028.
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Tepmetko products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 225MG BASE | Marketed (Rx) | None | 0 | None |
NDA 214096, held by EMD SERONO INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Tepmetko patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9284300 | April 29, 2028 | Drug product | None | 214096 |
| 8921357 | May 30, 2028 | Drug substance, Drug product | None | 214096 |
| 8658643 | July 4, 2028 | Method of use | U-3077 | 214096 |
| 9403799 | July 4, 2028 | Method of use | U-3077 | 214096 |
| 9062029 | July 4, 2028 | Drug product | None | 214096 |
| 8927540 | July 21, 2028 | Method of use | U-3078 | 214096 |
| 8329692 | October 30, 2029 | Drug substance, Drug product | None | 214096 |
| 8580781 | March 19, 2030 | Drug substance, Drug product | None | 214096 |
Tepmetko exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | February 3, 2026 | 214096 |
| ODE-325 | Orphan drug exclusivity | February 3, 2028 | 214096 |
Tepmetko NDC codes
Questions
Is there a generic for Tepmetko?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Tepmetko (tepotinib). The Orange Book shows its last listed patent expires March 19, 2030 and its last listed exclusivity ends February 3, 2028.
What is the generic name for Tepmetko?
The active ingredient in Tepmetko is tepotinib, per the FDA Orange Book.
When does the Tepmetko patent expire?
The last patent listed for Tepmetko in the Orange Book expires March 19, 2030. 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.