VERZENIO Drug Patent Profile

When do Verzenio patents expire, and when can generic versions of Verzenio launch?

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.

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:	83
Clinical Trials:	42
Patent Applications:	602
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

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/004302 Early 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
Eurasian Patent Organization	018808
Mexico	2011006757	INHIBIDORES DE PROTEINA CINASA. (PROTEIN KINASE INHIBITORS.)
Slovenia	2379528

Supplementary Protection Certificates for VERZENIO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2379528	9/2019	Austria		PRODUCT NAME: ABEMACICLIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1307 (MITTEILUNG) 20181001
2379528	C02379528/01	Switzerland		PRODUCT NAME: ABEMACICLIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66833 21.05.2019
2379528	C201930017	Spain		PRODUCT NAME: ABEMACICLIB O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/18/1307; DATE OF AUTHORISATION: 20180927; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1307; DATE OF FIRST AUTHORISATION IN EEA: 20180927

Market Dynamics and Financial Trajectory for VERZENIO

Introduction

VERZENIO, a CDK4/6 inhibitor developed by Eli Lilly, has been making significant strides in the treatment of breast cancer, particularly in the HR+/HER2- subtype. Here, we delve into the market dynamics and financial trajectory of this drug, highlighting its growth, challenges, and future prospects.

Mechanism of Action and Clinical Use

VERZENIO works by inhibiting the CDK4 and CDK6 enzymes, which are crucial for cell cycle progression. This mechanism is particularly effective in treating HR+/HER2- breast cancer, where the drug has shown promising results in reducing cancer recurrence and improving patient outcomes[3].

Market Share and Competition

In the kinase inhibitor class for breast cancer, Pfizer's Ibrance has traditionally held a strong lead. However, VERZENIO has been steadily gaining market share. As of recent reports, VERZENIO's market share in metastatic breast cancer has increased from 12% to 20%, with projections suggesting it could reach 28% by 2024[1].

Regulatory Milestones

VERZENIO received FDA approval in 2017 for the treatment of metastatic breast cancer. A significant milestone came in 2021 when it was approved as an adjuvant therapy for high-risk HR+/HER2- early breast cancer, following data showing a 25.3% reduction in cancer recurrence risk[1].

Financial Performance

Quarterly and Annual Sales

In Q3 2024, worldwide VERZENIO revenue increased by 32% to $1.37 billion, with U.S. revenue rising by 28% to $878.8 million. This growth is part of a broader trend, with Q2 2024 seeing a 44% increase in worldwide revenue to $1.33 billion and a 46% increase in U.S. revenue to $861.4 million[2][5].

Year-over-Year Growth

VERZENIO's sales have shown robust year-over-year growth. In the first quarter of 2024, sales reached $1.05 billion, a 40% increase from the previous year, although slightly below analyst expectations[4].

Market Forecast

Analysts project significant growth for VERZENIO, with Bernstein analysts predicting sales to reach $4.6 billion by 2024, surpassing consensus Wall Street estimates of $3.2 billion. This forecast is driven by the drug's success in early breast cancer and its growing market share in metastatic breast cancer[1].

Challenges and Setbacks

Despite its success, VERZENIO has faced some setbacks. The phase 3 CYCLONE-3 trial, which tested VERZENIO in combination with other therapies for metastatic hormone-sensitive prostate cancer, was terminated due to an interim analysis showing the combination was unlikely to outperform existing treatments[4].

Competitive Landscape

The market for ER+/HER2- breast cancer is competitive, with emerging therapies expected to challenge VERZENIO's dominance. However, VERZENIO's strong clinical data and expanding indications position it favorably against competitors like Pfizer's Ibrance[3].

Global Market Impact

The global market for breast cancer treatments is expected to grow due to increasing healthcare spending and extensive research. VERZENIO is well-positioned to benefit from this growth, especially with its approval in early breast cancer and its strong performance in metastatic cases[3].

Financial Impact on Eli Lilly

VERZENIO is one of the key growth drivers for Eli Lilly, along with other products like Mounjaro and Zepbound. The drug's revenue growth has contributed significantly to Lilly's overall financial performance, with the company reporting a 20% increase in worldwide revenue in Q3 2024, driven in part by VERZENIO's strong sales[2].

Gross Margin and Research Expenses

The favorable product mix and higher realized prices for VERZENIO have contributed to an increase in Eli Lilly's gross margin. However, the company has also seen an increase in research and development expenses, reflecting continued investments in its early and late-stage portfolio[2].

Future Prospects

Given its strong clinical data and expanding market share, VERZENIO is expected to continue its upward trajectory. The drug's potential in other cancer types and its ongoing research activities suggest further growth opportunities. Here is a quote from Bernstein analyst Ronny Gal, highlighting the drug's potential:

"Lilly is showing success with arguing for differentiation from Ibrance, and the growth will continue when the drug gains approval" in early breast cancer[1].

Key Takeaways

• Market Share Growth: VERZENIO has been gaining market share in metastatic breast cancer and is projected to reach 28% by 2024.
• Financial Performance: The drug has seen significant year-over-year growth, with Q3 2024 revenue increasing by 32% to $1.37 billion.
• Regulatory Milestones: Approved as an adjuvant therapy for high-risk HR+/HER2- early breast cancer, with a 25.3% reduction in cancer recurrence risk.
• Challenges: Faced setbacks in the CYCLONE-3 trial but remains a key growth driver for Eli Lilly.
• Future Prospects: Expected to continue growing due to strong clinical data and expanding indications.

FAQs

What is VERZENIO used for?

VERZENIO is used for the treatment of HR+/HER2- breast cancer, both in metastatic and early stages.

How has VERZENIO's market share evolved?

VERZENIO's market share in metastatic breast cancer has increased from 12% to 20% and is projected to reach 28% by 2024.

What are the financial projections for VERZENIO?

Analysts project VERZENIO sales to reach $4.6 billion by 2024, significantly higher than consensus estimates.

What challenges has VERZENIO faced?

VERZENIO faced a setback with the termination of the phase 3 CYCLONE-3 trial for metastatic hormone-sensitive prostate cancer.

How does VERZENIO compare to its competitors?

VERZENIO is gaining ground against competitors like Pfizer's Ibrance, thanks to its strong clinical data and expanding indications.

Sources

1. FiercePharma: "Look for Eli Lilly's Verzenio to hit $4.6B, thanks to early breast cancer win: analyst"
2. BioSpace: "Lilly reports Q3 2024 financial results highlighted by strong volume-driven revenue growth from new products"
3. ResearchAndMarkets: "United States VERZENIO Drug Insight and Market Forecast"
4. FiercePharma: "Lilly's growth drivers, Verzenio and Jardiance, suffer setbacks"
5. Eli Lilly Investor Relations: "Lilly Reports Q2 2024 Financial Results, Raises Full-Year Revenue Guidance"