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, US 7855211, US 7855211, US 7855211, US 7855211.

Listed patents · 5 unexpired

PatentClaimsExpires
US 7855211substance, product, use U-213528 Sep 2031
US 7855211substance, product, use U-198128 Sep 2031
US 7855211substance, product, use U-354628 Sep 2031
US 7855211substance, product, use U-326528 Sep 2031
US 7855211substance, product, use U-324228 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

  • 25 Oct 2026Generic tentatively approved · 208716-001

Products covered · 4

NDA · productFormStrengthListed expiry
208716 · 001 · RLDtablet, oral50MG28 Sep 2031
208716 · 002 · RLDtablet, oral100MG28 Sep 2031
208716 · 003 · RLDtablet, oral150MG28 Sep 2031
208716 · 004 · RLDtablet, oral200MG28 Sep 2031