FDA Orange Book
Is there a generic for Avmapki Fakzynja Co-pack (copackaged)?
Avmapki Fakzynja Co-pack (copackaged) contains avutometinib and defactinib. 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 Avmapki Fakzynja Co-pack (copackaged) (avutometinib and defactinib). The Orange Book shows its last listed patent expires December 29, 2042 and its last listed exclusivity ends May 8, 2032.
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Avmapki Fakzynja Co-pack (copackaged) products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, tablet, oral | EQ 0.8MG BASE;EQ 200MG BASE | Marketed (Rx) | None | 0 | None |
NDA 219616, held by VERASTEM INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Avmapki Fakzynja Co-pack (copackaged) patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7897792 | February 9, 2027 | Drug substance, Drug product | None | 219616 |
| 8247411 | April 17, 2028 | Drug substance, Drug product | None | 219616 |
| 7928109 | August 21, 2029 | Drug substance, Drug product | None | 219616 |
| 11400090 | October 29, 2038 | Method of use | U-4196 | 219616 |
| 11517573 | September 11, 2040 | Method of use | U-4196 | 219616 |
| 11517573 | September 11, 2040 | Method of use | U-4205 | 219616 |
| 11873296 | December 29, 2042 | Drug product | U-4196 | 219616 |
| 12509450 | December 29, 2042 | Drug product | None | 219616 |
Avmapki Fakzynja Co-pack (copackaged) exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | May 8, 2030 | 219616 |
| ODE-525 | Orphan drug exclusivity | May 8, 2032 | 219616 |
Questions
Is there a generic for Avmapki Fakzynja Co-pack (copackaged)?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Avmapki Fakzynja Co-pack (copackaged) (avutometinib and defactinib). The Orange Book shows its last listed patent expires December 29, 2042 and its last listed exclusivity ends May 8, 2032.
What is the generic name for Avmapki Fakzynja Co-pack (copackaged)?
The active ingredient in Avmapki Fakzynja Co-pack (copackaged) is avutometinib and defactinib, per the FDA Orange Book.
When does the Avmapki Fakzynja Co-pack (copackaged) patent expire?
The last patent listed for Avmapki Fakzynja Co-pack (copackaged) in the Orange Book expires December 29, 2042. 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.