Viewing data from:

VERZENIO

NDA

ABEMACICLIB | N208716 | ELI LILLY AND CO

4 strengths1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

2027

2028

2029

2030

2031

2032

Today

7855211

Sep. 28, 2031

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
Eli Lilly and Company v. Cipla Ltd. et al 1:2026cv00691 1 patentANDA 221201abemaciclib	D. Del.	2026-06-12	Active	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

4 trials from ClinicalTrials.gov — 4 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Cyclin-Dependent Kinase (CDK)4/6 Inhibitor Abemaciclib for Neurofibromatosis Type I (NF1) Related Atypical Neurofibromas NCT04750928	Phase 1/2	Recruiting	National Cancer Institute (NCI)	55	2021-11-29 → 2029-12-31
CB-103 With Either Lenvatinib or Abemaciclib in Patients With NOTCH ACC NCT05774899	Phase 1/2	Recruiting	Glenn J. Hanna	32	2023-06-01 → 2028-06-01
A Study of Abemaciclib and Cabozantinib in People With Clear Cell Renal Cell Carcinoma (ccRCC)NCT06835972	Phase 1/2	Recruiting	Memorial Sloan Kettering Cancer Center	43	2025-02-14 → 2027-02
Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI)NCT06169371	Phase 4	Recruiting	University of Illinois at Chicago	50	2023-12-28 → 2030-11

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Verzenio (2023)

Total Spending

$756.9M

Total Claims

50,481

Beneficiaries

8,217

Avg Cost/Unit

$275.07

Spending Trend

$216.6M(2019)→$286.2M(2020)→$324.6M(2021)→$474.2M(2022)→$756.9M(2023)

YoY Change:+6.3%

5yr CAGR:+6.3%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain12 active DMFs

11 active API suppliers hold Drug Master Files for this ingredient.

MSN LABORATORIES PRIVATE LTDABEMACICLIB

DMF 347142020

SHANDONG ANHONG PHARMACEUTICAL CO LTDABEMACICLIB

DMF 403152024

MSN LABORATORIES PRIVATE LTDABEMACICLIB

DMF 406122024

DR REDDYS LABORATORIES LTDABEMACICLIB

DMF 407992024

FORMOSA LABORATORIES INCABEMACICLIB

DMF 412502025

HETERO LABS LTDABEMACICLIB

DMF 413952025

CHANGZHOU PHARMACEUTICAL FACTORYABEMACICLIB

DMF 414802025

SCINOPHARM TAIWAN LTDABEMACICLIB

DMF 418702025

PORTON PHARMA SOLUTIONS LTDABEMACICLIB DRUG SUBSTANCE (NON-STERILE)

DMF 419032025

CIPLA LTDABEMACICLIB

DMF 424822025

ZAKLADY FARMACEUTYCZNE POLPHARMA SAABEMACICLIB

DMF 429902025

BEIJING HOPE PHARMACEUTICAL CO LTDABEMACICLIB

DMF 432392025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

11 letters from Drugs@FDA

Date	Submission	Document
Feb 28, 2025	SUPPL -19	View Letter (PDF)
Nov 14, 2024	SUPPL -17	View Letter (PDF)
Mar 6, 2023	SUPPL -10	View Letter (PDF)
Mar 6, 2023	SUPPL -11	View Letter (PDF)
Oct 14, 2021	SUPPL -7	View Letter (PDF)
Oct 14, 2021	SUPPL -6	View Letter (PDF)
Oct 14, 2021	SUPPL -8	View Letter (PDF)
Apr 1, 2020	SUPPL -4	View Letter (PDF)
Sep 9, 2019	SUPPL -3	View Letter (PDF)
Aug 20, 2018	SUPPL -1	View Letter (PDF)
Sep 28, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 50MG

RLD

1 patent0 exclusivities▴

TABLET;ORAL | Approved: Sep 28, 2017

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7855211	Sep 28, 2031	—	Yes	Yes		—

#002 — 100MG

RLD

1 patent0 exclusivities▾

TABLET;ORAL | Approved: Sep 28, 2017

#003 — 150MG

RLD

1 patent0 exclusivities▾

TABLET;ORAL | Approved: Sep 28, 2017

#004 — 200MG

RLD

1 patent0 exclusivities▾

TABLET;ORAL | Approved: Sep 28, 2017