abemaciclib · Eli Lilly And Co · NDA 208716
Verzenio
Earliest generic entry, as listed · earliest of 4 marketed strengths
28 Sep 2031
Blocked by patent: US 7855211.
Listed patents · 1 unexpired
5 Orange Book listing rows for 1 patent. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 7855211 | drug substance, drug product, use U-1981, U-2135, U-3242, U-3265, U-3546 | 28 Sep 2031 |
| US 7855211 listing row | drug substance, drug product, use U-1981 · sets the listed date | 28 Sep 2031 |
| US 7855211 listing row | drug substance, drug product, use U-2135 · sets the listed date | 28 Sep 2031 |
| US 7855211 listing row | drug substance, drug product, use U-3242 · sets the listed date | 28 Sep 2031 |
| US 7855211 listing row | drug substance, drug product, use U-3265 · sets the listed date | 28 Sep 2031 |
| US 7855211 listing row | drug substance, drug product, use U-3546 · sets the listed date | 28 Sep 2031 |
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 220238, Qilu Pharmaceutical Co., Ltd. · 208716-001Tentative approval 6 Nov 2025Detected 25 Oct 2026Historical import
Products covered · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 208716 · 001 · RLD | tablet, oral | 50MG | 28 Sep 2031 |
| 208716 · 002 · RLD | tablet, oral | 100MG | 28 Sep 2031 |
| 208716 · 003 · RLD | tablet, oral | 150MG | 28 Sep 2031 |
| 208716 · 004 · RLD | tablet, oral | 200MG | 28 Sep 2031 |