lenvatinib mesylate · Eisai Inc · NDA 206947
Lenvima
Earliest generic entry, as listed · earliest of 2 marketed strengths
15 Nov 2038
Blocked by patent: US 12226409 (pediatric extension).
Listed patents · 9 unexpired
18 Orange Book listing rows for 9 patents, including 9 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 12226409 | use U-4146 | 15 Nov 2038 |
| US 12226409 listing row | use U-4146 | 15 May 2038 |
| US 12226409 listing row | pediatric extension · sets the listed date | 15 Nov 2038 |
| US 12083112 | use U-3996, U-3997 | 3 Sep 2036 |
| US 12083112 listing row | use U-3996 | 3 Mar 2036 |
| US 12083112 listing row | use U-3997 | 3 Mar 2036 |
| US 12083112 listing row | pediatric extension | 3 Sep 2036 |
| US 11090386 | use U-3519 | 23 Aug 2036 |
| US 11090386 listing row | use U-3519 | 23 Feb 2036 |
| US 11090386 listing row | pediatric extension | 23 Aug 2036 |
| US 10259791 | drug substance | 26 Feb 2036 |
| US 10259791 listing row | drug substance | 26 Aug 2035 |
| US 10259791 listing row | pediatric extension | 26 Feb 2036 |
| US 10407393 | drug substance | 26 Feb 2036 |
| US 10407393 listing row | drug substance | 26 Aug 2035 |
| US 10407393 listing row | pediatric extension | 26 Feb 2036 |
| US 11186547 | drug substance | 26 Feb 2036 |
| US 11186547 listing row | drug substance | 26 Aug 2035 |
| US 11186547 listing row | pediatric extension | 26 Feb 2036 |
| US 12508313 | drug product | 4 Apr 2031 |
| US 12508313 listing row | drug product | 4 Oct 2030 |
| US 12508313 listing row | pediatric extension | 4 Apr 2031 |
| US 9006256 | use U-1695 | 27 Jan 2028 |
| US 9006256 listing row | use U-1695 | 27 Jul 2027 |
| US 9006256 listing row | pediatric extension | 27 Jan 2028 |
| US 7612208 | pediatric extension | 19 Mar 2027 |
Exclusivities · 2 unexpired
| PED | pediatric (6 months added) | 3 Oct 2027 |
| M-14 | miscellaneous (3 years) | 3 Apr 2027 |
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 · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 206947 · 001 · RLD | capsule, oral | EQ 4MG BASE | 15 Nov 2038 |
| 206947 · 002 · RLD | capsule, oral | EQ 10MG BASE | 15 Nov 2038 |
Expired or delisted (5)
- US 7612208 · substance, product · 19 Sep 2026
- US 7253286 · — · 24 Apr 2026
- US 7253286 · substance, product · 24 Oct 2025
- PED · 15 Feb 2026
- ODE-196 · 15 Aug 2025