eslicarbazepine acetate · Sumitomo Pharma Am · NDA 022416
Aptiom
Blocked by patent: US 9750747. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
FDA has approved 2 generic applications (ANDAs) for Aptiom, though its earliest generic-entry date is 24 Aug 2032 as listed. A generic can be approved before that date when it leaves out a patented use (a section viii carve-out), challenges a patent, or settles with the brand company. An approval is not a launch: cliffwatch does not track launches. Approval is not launch
Listed patents · 5 unexpired
6 Orange Book listing rows for 5 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 9750747 | use U-2041, U-2121 | 24 Aug 2032 |
| US 9750747 listing row | use U-2041 · sets the listed date | 24 Aug 2032 |
| US 9750747 listing row | use U-2121 · sets the listed date | 24 Aug 2032 |
| US 8372431 | drug product | 17 Apr 2030 |
| US 10912781 | drug product | 23 Oct 2028 |
| US 9566244 | drug 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
- Generic approved · ANDA 211247, Sph Zhongxi Pharm · 022416-001Approved 3 Nov 2025Detected 25 Oct 2026Historical import
- Generic approved · ANDA 216481, Aurobindo Pharma · 022416-001Approved 5 Aug 2026Detected 25 Oct 2026Historical import
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