verzenio Drug Patent Profile

Which patents cover Verzenio, and what generic alternatives are available?

Verzenio is a drug marketed by Eli Lilly And Co and is included in one NDA. There is one patent protecting this drug.

This drug has fifty-two patent family members in forty-five countries.

The generic ingredient in VERZENIO is abemaciclib. One supplier is listed for this compound. Additional details are available on the abemaciclib profile page.

DrugPatentWatch^® Generic Entry Outlook for Verzenio

Verzenio was eligible for patent challenges on September 28, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 28, 2031. This may change due to patent challenges or generic licensing.

There is one tentative approval for the generic drug (abemaciclib), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for verzenio

International Patents:	52
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	42
Patent Applications:	2,482
Drug Prices:	Drug price information for verzenio
What excipients (inactive ingredients) are in verzenio?	verzenio excipients list
DailyMed Link:	verzenio at DailyMed

See drug prices for verzenio

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for verzenio

Constraining patent/regulatory exclusivity:

7,855,211

NDA:

208716

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for verzenio

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Breast Cancer Research Foundation	Phase 2
Praful Ravi	Phase 1/Phase 2
Bayer	Phase 1/Phase 2

See all verzenio clinical trials

Pharmacology for verzenio

Drug Class	Kinase Inhibitor
Mechanism of Action	Kinase Inhibitors

US Patents and Regulatory Information for verzenio

verzenio is protected by five US patents.

This potential generic entry date is based on patent 7,855,211.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eli Lilly And Co	VERZENIO	abemaciclib	TABLET;ORAL	208716-001	Sep 28, 2017		RX	Yes	No	7,855,211		Y	Y
Eli Lilly And Co	VERZENIO	abemaciclib	TABLET;ORAL	208716-002	Sep 28, 2017		RX	Yes	No	7,855,211		Y	Y
Eli Lilly And Co	VERZENIO	abemaciclib	TABLET;ORAL	208716-004	Sep 28, 2017		RX	Yes	Yes	7,855,211		Y	Y
Eli Lilly And Co	VERZENIO	abemaciclib	TABLET;ORAL	208716-003	Sep 28, 2017		RX	Yes	No	7,855,211		Y	Y

EU/EMA Drug Approvals for verzenio

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Eli Lilly Nederland B.V.	Verzenios	abemaciclib	EMEA/H/C/004302Early Breast CancerVerzenios in combination with endocrine therapy is indicated for the adjuvant treatment of adult patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, node positive early breast cancer at high risk of recurrence (see section 5.1).In pre or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.Advanced or Metastatic Breast CancerVerzenios is indicated for the treatment of women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy.In pre- or perimenopausal women, the endocrine therapy should be combined with a LHRH agonist.	Authorised	no	no	no	2018-09-26

International Patents for verzenio

When does loss-of-exclusivity occur for verzenio?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Dominican Republic

Ecuador

Eurasian Patent Organization

European Patent Office

Finland

Guatemala

Honduras

Hong Kong

Hungary

Israel

Japan

Jordan

Lithuania

Luxembourg

Malaysia

Mexico

Morocco

Netherlands

New Zealand

Norway

Panama

Peru

Poland

Portugal

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering verzenio around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	5417453
Brazil	PI0924183
Hungary	S1900014
Taiwan	201031653	Protein kinase inhibitors
Croatia	P20131051

Supplementary Protection Certificates for verzenio

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2379528	122019000010	Germany		PRODUCT NAME: ABEMACICLIB; REGISTRATION NO/DATE: EU/1/18/1307 20180927
2379528	PA2019004,C2379528	Lithuania		PRODUCT NAME: ABEMACIKLIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/18/1307 20180927
2379528	300969	Netherlands		PRODUCT NAME: ABEMACICLIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/18/1307 20181001
2379528	SPC/GB19/012	United Kingdom		PRODUCT NAME: ABEMACICLIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/18/1307 20181001; UK PLGB14895/0263 20181001; UK PLGB14895/0264 20181001; UK PLGB14895/0265 20181001
2379528	2019/015	Ireland		PRODUCT NAME: ABEMACICLIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/18/1307 20180927

Market Dynamics and Financial Trajectory of VERZENIO (Abemaciclib)

Last updated: November 7, 2025

Introduction

VERZENIO (abemaciclib), developed and marketed by Eli Lilly and Company, is a CDK4 & 6 inhibitor approved primarily for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer. Since its initial approval in 2017, VERZENIO has established itself within a competitive oncology landscape, characterized by rapid innovation, evolving regulatory standards, and shifting market demands. This report explores the underlying market dynamics influencing VERZENIO's growth trajectory and offers insights into its future financial outlook.

Market Landscape and Competitive Position

Growing Incidence of HR-Positive, HER2-Negative Breast Cancer

The global breast cancer burden continues to escalate, with an estimated 2.3 million new cases worldwide in 2020, of which approximately 70% are HR-positive, HER2-negative subtypes (per GLOBOCAN [1]). This subgroup significantly benefits from CDK4 & 6 inhibitors, underpinning sustained demand for targeted therapies like VERZENIO.

Evolving Treatment Paradigms

The therapeutic landscape for metastatic breast cancer has shifted toward personalized medicine, integrating CDK4 & 6 inhibitors—VERZENIO, Pfizer’s IBRANCE (palbociclib), and Novartis’s Kisqali (ribociclib)—as standard combination treatments with endocrine therapy. Regulatory approvals in earlier lines of therapy, including first-line indications, have expanded the market and enhanced revenue prospects.

Competitive Differentiators

Unlike other CDK4 & 6 inhibitors, VERZENIO exhibits distinctive pharmacologic attributes, including its oral administration, tolerability profile, and activity in certain high-risk populations. However, comparative efficacy data continues to influence physician preferences and formulary decisions. The competitive landscape necessitates continued innovation and robust positioning of VERZENIO.

Market Dynamics Influencing VERZENIO

Regulatory Approvals and Label Expansions

Eli Lilly’s strategic filings have expanded VERZENIO’s indication scope. Notably, in 2019, the FDA approved VERZENIO in combination with endocrine therapy for early-stage HR-positive, HER2-negative, node-positive, high-risk early breast cancer (adjuvant setting), broadening its market [2]. These label expansions substantially enhance revenue potential and market penetration.

Pricing Strategies and Reimbursement Policies

Pricing remains sensitive given the high cost of cancer therapies. Eli Lilly employs value-based pricing, emphasizing clinical benefits and quality-of-life improvements. Reimbursement approvals vary globally, with some markets imposing price caps, influencing access and sales volume.

Patent Landscape and Biosimilar Entry

Patent protections for VERZENIO are pivotal to maintaining exclusivity. As patents approach expiry (~2027), the threat of biosimilars and generics could erode market share unless Eli Lilly innovates through formulation improvements or new indications.

Pipeline Developments and Companion Diagnostics

Ongoing clinical trials examining VERZENIO in other cancers and combination regimens could extend its lifecycle. Additionally, companion diagnostics enable patient stratification, improving efficacy and positioning VERZENIO favorably amidst personalized medicine trends.

Financial Trajectory and Revenue Projections

Historical Revenue Performance

Since its launch, VERZENIO has experienced rapid growth. Eli Lilly reported approximately $1.4 billion USD in sales in 2021, predominantly driven by breast cancer indications. Rapid uptake in the U.S. and Europe contributed substantially, with emerging markets gradually expanding.

Forecasted Growth Drivers

• Market Penetration: Increasing adoption in the adjuvant setting following regulatory approval expands the patient population.
• Indication Expansion: New therapeutic labels and combo regimens in other cancers, such as non-small cell lung cancer (NSCLC), could diversify revenue streams.
• Geographical Expansion: Greater penetration into emerging markets, where breast cancer incidence is rising, and healthcare infrastructure improves.

Projected Financial Outlook (2023–2027)

Analysts anticipate a compound annual growth rate (CAGR) of approximately 10-12% over the next five years, fueled by ongoing adoption, label expansions, and pipeline milestones. Potential patent expiries necessitate strategic diversification to prevent revenue erosion.

Risks and Challenges

• Competitive Market Dynamics: Entrenched rivals with similar efficacy profiles may limit market share. Differentiation relies on clinical outcomes and cost-effectiveness.
• Regulatory Uncertainties: Delays or rejections of label extensions or new indications can impact growth.
• Pricing and Reimbursement Pressures: Market access challenges could suppress revenue growth, especially in cost-sensitive regions.

Strategic Implications for Stakeholders

Pharmaceutical Companies: Heavy investment in clinical trials, companion diagnostics, and global regulatory navigation is essential for maintaining competitive advantage. Developing next-generation inhibitors or combination strategies can sustain growth.

Investors: Monitoring pipeline progress, regulatory milestones, and market penetration metrics is crucial for valuation assessments. Patent timelines will influence long-term strategic positioning.

Healthcare Providers and Payers: Emphasis on value-based care models will heavily influence formulary decisions and reimbursement frameworks.

Conclusion

VERZENIO's market dynamics are shaped by its expanding clinical indications, competitive positioning, and evolving regulatory and reimbursement landscapes. Its financial trajectory appears promising, characterized by sustained growth driven by increased adoption and geographic expansion. However, competitive pressures, patent cliffs, and market access challenges underscore the importance of strategic innovation and diversification for long-term profitability.

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Key Takeaways

• Robust Growth Potential: VERZENIO benefits from increased indications, especially in early breast cancer, and expanding geographic markets.
• Competitive Advantages: Unique pharmacological profile and label expansions differentiate VERZENIO but must be supported by ongoing clinical efficacy.
• Market Risks: Patent expiry, biosimilar competition, and pricing pressures require strategic foresight.
• Pipeline and Innovation: Continued innovation in combination therapies and potential entry into new oncological indications will be pivotal.
• Investment Focus: Stakeholders should closely monitor regulatory milestones, sales data, and competitive moves to optimize decision-making.

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FAQs

1. How does VERZENIO differ from other CDK4 & 6 inhibitors?
VERZENIO exhibits a distinct pharmacokinetic profile, oral dosing schedule, and tolerability, especially in high-risk patient subgroups, distinguishing it from palbociclib and ribociclib. Its activity in tamoxifen-resistant disease also offers strategic advantages.

2. What are the main markets driving VERZENIO’s revenue growth?
Primary growth drivers include the United States and Europe, with emerging markets gradually contributing as access and healthcare infrastructure improve.

3. How do patent expirations impact VERZENIO’s future?
Patent expiration around 2027 could open pathways for biosimilars, potentially reducing revenue unless Eli Lilly innovates or expands indications.

4. What role do companion diagnostics play in VERZENIO’s success?
Companion diagnostics enable precise patient stratification, improving clinical outcomes and fostering personalized treatment plans, thus supporting market adoption.

5. What upcoming developments could influence VERZENIO’s trajectory?
Regulatory approvals for newer indications, pipeline trial results, and additional combination regimens are key developments shaping its future market position.

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References

[1] GLOBOCAN 2020, International Agency for Research on Cancer.
[2] FDA Press Release, 2019. Eli Lilly’s VERZENIO approved for early-stage breast cancer.