avutometinib potassium; defactinib hydrochloride · Verastem Inc · NDA 219616
Avmapki Fakzynja Co-Pack (Copackaged)
Earliest generic entry, as listed
29 Dec 2042
Blocked by patent: US 11873296, US 12509450.
Listed patents · 7 unexpired
8 Orange Book listing rows for 7 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 11873296 | drug product, use U-4196 · sets the listed date | 29 Dec 2042 |
| US 12509450 | drug product · sets the listed date | 29 Dec 2042 |
| US 11517573 | use U-4196, U-4205 | 11 Sep 2040 |
| US 11517573 listing row | use U-4196 | 11 Sep 2040 |
| US 11517573 listing row | use U-4205 | 11 Sep 2040 |
| US 11400090 | use U-4196 | 29 Oct 2038 |
| US 7928109 | drug substance, drug product | 21 Aug 2029 |
| US 8247411 | drug substance, drug product | 17 Apr 2028 |
| US 7897792 | drug substance, drug product | 9 Feb 2027 |
Exclusivities · 2 unexpired
| ODE-525 | orphan drug (7 years) | 8 May 2032 |
| NCE | new chemical entity (5 years) | 8 May 2030 |
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 219616 · 001 · RLD | capsule, tablet, oral | EQ 0.8MG BASE;EQ 200MG BASE | 29 Dec 2042 |