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

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

105 trials from ClinicalTrials.gov — 10 recruiting, 23 active, 41 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
(CLONEVO): Cell cycLe inhbitiON to Target the EVolution of UrOthelial Cancer NCT03837821	Early Phase 1	Active	Weill Medical College of Cornell University	20	2019-02-05 → 2026-12
Fulvestrant Plus Abemaciclib in Women With Advanced Low Grade Serous Carcinoma NCT03531645	Phase 2	Active	M.D. Anderson Cancer Center	18	2019-08-13 → 2027-09-30
Abemaciclib in Patients with Oligodendroglioma NCT03969706	Phase 2	Active	Stephen Bagley, MD, MSCE	10	2019-05-15 → 2027-05-15
A Study of Abemaciclib (LY2835219) in Participants With Non-Small Cell Lung Cancer or Breast Cancer NCT02779751	Phase 1	Active	Eli Lilly and Company	100	2016-11-14 → 2026-12
A Study of Abemaciclib in Recurrent Glioblastoma NCT02981940	Phase 2	Active	Dana-Farber Cancer Institute	45	2017-02-09 → 2026-06-30
A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer NCT02246621	Phase 3	Active	Eli Lilly and Company	493	2014-11-06 → 2026-12
Endocrine Therapy Plus CDK4/6 in First or Second Line for Hormone (SONIA) Receptor Positive Advanced Breast Cancer NCT03425838	Phase 3	Active	Borstkanker Onderzoek Groep	1,050	2017-11-09 → 2028-12
Testing the Addition of Copanlisib to Usual Treatment (Fulvestrant and Abemaciclib) in Metastatic Breast Cancer NCT03939897	Phase 1	Active	National Cancer Institute (NCI)	24	2020-06-17 → 2026-08-14
A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer or Endometrial Cancer NCT04188548	Phase 1	Active	Eli Lilly and Company	379	2019-12-10 → 2027-12
A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer NCT02763566	Phase 3	Active	Eli Lilly and Company	463	2016-12-05 → 2028-03

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

VA Federal Supply Schedule

Government-negotiated contract prices | 8 NDCs (4 FSS, 4 Big4)

Lowest Price

$2848.37

Highest Price

$3692.73

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00002-4483-54VERZENIO 50MG TAB	$3692.73	FSS	Eli Lilly & Company	09/28/2030
00002-4483-54VERZENIO 50MG TAB	$2848.37	Big4	Eli Lilly & Company	09/28/2030
00002-4815-54VERZENIO 100MG TAB	$3692.73	FSS	Eli Lilly & Company	09/28/2030
00002-4815-54VERZENIO 100MG TAB	$2855.36	Big4	Eli Lilly & Company	09/28/2030
00002-6216-54VERZENIO 200MG TAB	$3692.73	FSS	Eli Lilly & Company	09/28/2030
00002-6216-54VERZENIO 200MG TAB	$2874.52	Big4	Eli Lilly & Company	09/28/2030
00002-5337-54VERZENIO 150MG TAB	$3692.73	FSS	Eli Lilly & Company	09/28/2030
00002-5337-54VERZENIO 150MG TAB	$2853.88	Big4	Eli Lilly & Company	09/28/2030

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Verzenio (2024)

Total Spending

$1.1B

Total Claims

71,933

Beneficiaries

11,239

Avg Cost/Unit

$268.49

Spending Trend

$216.6M(2019)→$286.2M(2020)→$324.6M(2021)→$474.2M(2022)→$756.9M(2023)→$1.1B(2024)

YoY Change:-2.4%

5yr CAGR:+4.1%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain15 active DMFs

14 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

GRANULES INDIA LTDABEMACICLIB

DMF 436622026

EGIS PHARMACEUTICALS PLCABEMACICLIB USP

DMF 436802026

SICHUAN ELIXIR PHARMACEUTICAL CO LTDABEMACICLIB

DMF 438702026

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) · 4 use codes

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