ABEMACICLIB - Generic Drug Details

What are the generic drug sources for abemaciclib and what is the scope of freedom to operate?

Abemaciclib is the generic ingredient in one branded drug marketed by Eli Lilly And Co and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Abemaciclib has fifty-one patent family members in forty-five countries.

One supplier is listed for this compound.

Summary for ABEMACICLIB

International Patents:	51
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	83
Clinical Trials:	184
Patent Applications:	1,930
What excipients (inactive ingredients) are in ABEMACICLIB?	ABEMACICLIB excipients list
DailyMed Link:	ABEMACICLIB at DailyMed

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

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 ABEMACICLIB

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

Sponsor	Phase
Breast Cancer Research Foundation	Phase 2
Mridula George, MD	Phase 1
University of Illinois at Chicago	Phase 4

See all ABEMACICLIB clinical trials

Pharmacology for ABEMACICLIB

Drug Class	Kinase Inhibitor
Mechanism of Action	Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ABEMACICLIB

L01EF	Cyclin-dependent kinase (CDK) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for ABEMACICLIB

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	208716-003	Sep 28, 2017		RX	Yes	No			Y	Y
Eli Lilly And Co	VERZENIO	abemaciclib	TABLET;ORAL	208716-004	Sep 28, 2017		RX	Yes	Yes			Y	Y
Eli Lilly And Co	VERZENIO	abemaciclib	TABLET;ORAL	208716-001	Sep 28, 2017		RX	Yes	No			Y	Y
Eli Lilly And Co	VERZENIO	abemaciclib	TABLET;ORAL	208716-004	Sep 28, 2017		RX	Yes	Yes
Eli Lilly And Co	VERZENIO	abemaciclib	TABLET;ORAL	208716-001	Sep 28, 2017		RX	Yes	No

EU/EMA Drug Approvals for ABEMACICLIB

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 ABEMACICLIB

Country	Patent Number	Title	Estimated Expiration
Costa Rica	20110343	INHIBIDORES DE PROTEÍNA CINASA
Ecuador	SP11011157	INHIBIDORES DE PROTEÍNA CINASA
Japan	5417453
Cyprus	1114841
Japan	2012513396

Supplementary Protection Certificates for ABEMACICLIB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2379528	CA 2019 00008	Denmark		PRODUCT NAME: ABEMACICLIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/18/1307 20181001
2379528	1990013-3	Sweden		PRODUCT NAME: ABEMACICLIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/18/1307 20181001
2379528	132019000000037	Italy		PRODUCT NAME: ABEMACICLIB(VERZENIOS); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1307, 20181001
2379528	PA2019004	Lithuania		PRODUCT NAME: ABEMACIKLIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/18/1307 20180927
2379528	LUC00106	Luxembourg		PRODUCT NAME: ABEMACICLIB ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (VERZENIOS); AUTHORISATION NUMBER AND DATE: EU/1/18/1307 20181001

ABEMACICLIB Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ABEMACICLIB

Introduction

ABEMACICLIB, marketed under the brand name VERZENIO, is a CDK4/6 inhibitor developed by Eli Lilly and Company. It has been a significant player in the treatment of breast cancer, particularly in the hormone receptor-positive (HR+), HER2-negative (HER2-) subtype. Here, we delve into the market dynamics and financial trajectory of ABEMACLIB, highlighting its growth, challenges, and future prospects.

Mechanism of Action and Clinical Use

ABEMACICLIB 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[2].

Market Size and Forecast

The global ABEMACICLIB market is valued at USD 1.28 billion in 2023 and is projected to reach USD 5.27 billion by 2030, growing at a Compound Annual Growth Rate (CAGR) of 29.91% during the forecast period 2024-2030. This robust growth is driven by several key factors[1].

Global Market Drivers

Increased Breast Cancer Incidence

The rising incidence of breast cancer, especially in postmenopausal women, has significantly impacted the market for ABEMACICLIB. The need for advanced therapeutic alternatives is fueling the demand for this drug[1].

Regulatory Approvals and Combination Therapies

Regulatory approvals for new applications or in combination with other medications can substantially boost market growth. For instance, the approval of ABEMACICLIB as an adjuvant therapy for high-risk HR+/HER2- early breast cancer has expanded its market potential[2].

Patient Advocacy and Awareness

Patients' increased knowledge of breast cancer and the availability of cutting-edge treatments, along with the activities of patient advocacy organizations, are driving the demand for ABEMACICLIB[1].

Healthcare Infrastructure and Access

Greater accessibility of ABEMACICLIB to a broader patient population, especially in emerging nations, is a key driver of market growth. Favorable health insurance and reimbursement policies also play a crucial role in making the drug more accessible[1].

Research and Development

Ongoing studies into breast cancer treatments may uncover new applications or drug combinations for ABEMACICLIB, further accelerating market expansion. Positive clinical trial findings, particularly those showing the treatment's effectiveness in various patient populations, significantly influence the market potential[1].

Global Market Restraints

High Treatment Cost

Like other targeted cancer medicines, ABEMACICLIB is expensive, making it less accessible in areas with limited health insurance coverage or where patients must bear a significant portion of the costs themselves[1].

Competition

The presence of other CDK4/6 inhibitors such as ribociclib and palbociclib leads to price competition and may reduce ABEMACICLIB's market share. The upcoming expiration of ABEMACICLIB's patents in 2031 could also lead to generic competition, driving down costs and reducing the brand-name drug's market share[1][2].

Healthcare Infrastructure Limitations

Weak healthcare systems or insufficient access to specialized cancer treatment facilities in some regions can limit the use of ABEMACICLIB. Reimbursement issues and market saturation in developed economies where most eligible patients are already on similar medications are additional restraints[1].

Clinical Trial Outcomes and Resistance

Unfavorable clinical trial outcomes or the emergence of resistance and tolerance to ABEMACICLIB over time can negatively impact its business. The COVID-19 pandemic has also disrupted healthcare systems and supply chains, affecting the availability and distribution of the drug[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].

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[2].

Market Forecast

Analysts predict significant growth for VERZENIO, with Bernstein analysts forecasting 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[2].

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.

Combination Therapies

The Phase 1b data for the combination of vepdegestrant and ABEMACICLIB shows promising efficacy, with a 62.5% clinical benefit rate and 26.7% overall response rate. This combination therapy could further expand the market potential of ABEMACICLIB[5].

Regulatory Milestones

Approved as an adjuvant therapy for high-risk HR+/HER2- early breast cancer, ABEMACICLIB has demonstrated a 25.3% reduction in cancer recurrence risk. Such regulatory milestones are crucial for its market growth[2].

Differentiation and Market Share

As noted by Bernstein analyst Ronny Gal, "Lilly is showing success with arguing for differentiation from Ibrance, and the growth will continue when the drug gains approval" in early breast cancer. This differentiation strategy is key to maintaining and growing its market share[2].

Key Players

The major players in the global ABEMACICLIB market include Eli Lilly and Company, Novartis AG, Pfizer Inc., AstraZeneca, Celltrion, Inc., Bristol-Myers Squibb Company, Baxter Healthcare Corporation, GlaxoSmithKline plc, Merck & Co., Inc., and Sanofi S.A.[1].

Market Segmentation

The global ABEMACICLIB market is segmented based on indication, distribution channel, combination therapy, and geography. The primary indication is breast cancer, particularly HR+/HER2- advanced or metastatic breast cancer. Geographically, the market is analyzed across North America, Europe, Asia-Pacific, Middle East and Africa, and Latin America[1].

Conclusion

ABEMACICLIB has established itself as a critical component in the treatment of breast cancer, driven by its robust clinical data and expanding market share. Despite facing challenges such as high treatment costs and competition from other CDK4/6 inhibitors, the drug's future prospects look promising due to ongoing research, favorable regulatory milestones, and growing demand.

Key Takeaways

• Market Share Growth: VERZENIO is projected to reach a 28% market share in metastatic breast cancer 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: Faces competition and potential generic entry in 2031.
• Future Prospects: Expected to continue growing due to strong clinical data and expanding indications.

FAQs

What is the current market size of ABEMACICLIB?

The global ABEMACICLIB market size is valued at USD 1.28 billion in 2023[1].

What is the projected growth rate of the ABEMACICLIB market?

The market is projected to grow at a CAGR of 29.91% from 2024 to 2030[1].

What are the primary drivers of the ABEMACICLIB market?

The primary drivers include increased breast cancer incidence, regulatory approvals for new applications, patient advocacy, and favorable healthcare infrastructure and access[1].

Who are the major players in the ABEMACICLIB market?

Major players include Eli Lilly and Company, Novartis AG, Pfizer Inc., AstraZeneca, and others[1].

When are the patents for ABEMACICLIB set to expire?

The earliest date for generic entry will be September 28, 2031[2].

What are the potential future applications of ABEMACICLIB?

The drug has potential in other cancer types and is being researched in combination therapies, such as with vepdegestrant[5].

Sources

1. Verified Market Research: Abemaciclib Market Size, Trends, Share, Growth & Forecast.
2. Drug Patent Watch: When do the patents on VERZENIO expire, and when will generic entry occur?
3. Research Nester: CDK4/6 Inhibitor Drugs Market Size & Share | Growth Forecasts 2036.
4. Market Research Intellect: Global abemaciclib market size and forecast.
5. Stock Titan: Arvinas and Pfizer Announce Initial Phase 1b Data from the TACTIVE-U Trial.