eslicarbazepine acetate · Sumitomo Pharma Am · NDA 022416
Aptiom
Earliest generic entry, as listed · earliest of 4 marketed strengths
24 Aug 2032
Blocked by patent: US 9750747, US 9750747. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 6 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9750747 | use U-2121 | 24 Aug 2032 |
| US 9750747 | use U-2041 | 24 Aug 2032 |
| US 8372431 | product | 17 Apr 2030 |
| US 10912781 | product | 23 Oct 2028 |
| US 9566244 | product | 23 Oct 2028 |
| US 9763954 | use U-2123 | 13 Sep 2028 |
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
- 25 Oct 2026Generic approved · 022416-0013 Nov 2025
- 25 Oct 2026Generic approved · 022416-0015 Aug 2026
Products covered · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022416 · 001 · RLD | tablet, oral | 200MG | 24 Aug 2032 |
| 022416 · 002 · RLD | tablet, oral | 400MG | 24 Aug 2032 |
| 022416 · 003 · RLD | tablet, oral | 600MG | 24 Aug 2032 |
| 022416 · 004 · RLD | tablet, oral | 800MG | 24 Aug 2032 |
Expired or delisted (2)
- US 9206135 · substance · 21 Apr 2026
- US 9643929 · product · 21 Apr 2026