binimetinib · Array Biopharma Inc · NDA 210498
Mektovi
Earliest generic entry, as listed
18 Oct 2033
Blocked by patent: US 9562016, US 9598376, US 9980944.
Listed patents · 7 unexpired
9 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 9562016 | drug substance, drug product · sets the listed date | 18 Oct 2033 |
| US 9598376 | use U-2330 · sets the listed date | 18 Oct 2033 |
| US 9980944 | use U-2334 · sets the listed date | 18 Oct 2033 |
| US 9314464 | use U-2332, U-3737 | 4 Jul 2031 |
| US 9314464 listing row | use U-2332 | 4 Jul 2031 |
| US 9314464 listing row | use U-3737 | 4 Jul 2031 |
| US 10005761 | use U-2331, U-3737 | 27 Aug 2030 |
| US 10005761 listing row | use U-2331 | 27 Aug 2030 |
| US 10005761 listing row | use U-3737 | 27 Aug 2030 |
| US 9850229 | use U-2333 | 27 Aug 2030 |
| US 7777050 | drug substance, drug product | 13 Mar 2027 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
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
- Generic tentatively approved · ANDA 217678, Alembic Pharms Ltd · 210498-001Tentative approval 18 Jun 2026Detected 25 Oct 2026Historical import
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 210498 · 001 · RLD | tablet, oral | 15MG | 18 Oct 2033 |
Expired or delisted (1)
- I-928 · 11 Oct 2026