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-two patent family members in forty-five countries.

One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for ABEMACICLIB

International Patents:	52
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	83
Clinical Trials:	213
What excipients (inactive ingredients) are in ABEMACICLIB?	ABEMACICLIB excipients list
DailyMed Link:	ABEMACICLIB at DailyMed

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

Constraining patent/regulatory exclusivity:

7,855,211

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
National Cancer Institute (NCI)	PHASE1
Eli Lilly and Company	PHASE3
Memorial Sloan Kettering Cancer Center	PHASE2

See all ABEMACICLIB clinical trials

Generic filers with tentative approvals for ABEMACICLIB

Applicant	Application No.	Strength	Dosage Form
		50MG	TABLET
		100MG	TABLET
		150MG	TABLET

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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	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	208716-001	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

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/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 ABEMACICLIB

Country	Patent Number	Title	Estimated Expiration
Poland	2379528
Slovenia	2379528
Japan	2012513396
Australia	2009330365
Malaysia	150547	PROTEIN KINASE INHIBITORS
Honduras	2011001701
New Zealand	593114	Compounds comprising benzimidazolyl, pyrimidinyl, and pyridinyl moieties which are useful as protein kinase inhibitors

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	PA2019004	Lithuania		PRODUCT NAME: ABEMACIKLIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/18/1307 20180927
2379528	C20190008 00271	Estonia		PRODUCT NAME: ABEMATSIKLIIB;REG NO/DATE: EU/1/18/1307 01.10.2018
2379528	LUC00106	Luxembourg		PRODUCT NAME: ABEMACICLIB ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (VERZENIOS); AUTHORISATION NUMBER AND 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	PA2019004,C2379528	Lithuania		PRODUCT NAME: ABEMACIKLIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/18/1307 20180927
2379528	C02379528/01	Switzerland		PRODUCT NAME: ABEMACICLIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66833 21.05.2019

Market Dynamics and Financial Trajectory for Abemaciclib

Last updated: November 27, 2025

Executive Summary

Abemaciclib, branded as Verzenio®, is a selective cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor developed by Lilly (Eli Lilly and Company) for treating hormone receptor-positive, HER2-negative (HR+/HER2−) advanced or metastatic breast cancer. Since its FDA approval in 2017, Abemaciclib has emerged as a significant contender in the targeted breast cancer therapeutic landscape. This report explores the drug's market dynamics, growth trajectory, competitive positioning, and financial outlook up to 2023 and beyond, offering insights for industry stakeholders and investors.

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1. Introduction to Abemaciclib

Mechanism of Action

Abemaciclib blocks CDK4/6, crucial regulators of cell cycle progression, thereby inhibiting tumor cell proliferation. Its selectivity differentiates it from competitors, potentially leading to distinct efficacy and safety profiles.

Approval Timeline

• FDA approval: August 2017 for HR+, HER2− advanced or metastatic breast cancer.
• Additional approvals: June 2018 in combination with endocrine therapy; subsequent approvals expanded indications to adjuvant settings and combinations.

Indications

Indication	Approved Date	Key Notes
HR+/HER2− advanced or metastatic breast cancer	2017	Monotherapy and combination with endocrine therapy
Adjuvant setting (early-stage breast cancer)	2021 (Phase 3 approval)	Pending further data for full approval

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2. Market Size and Segmentation

Global Breast Cancer Market Overview (2023)

Segment	Market Size (USD Billion)	CAGR (2023-2028)	Key Drivers
HR+/HER2− Breast Cancer Therapeutics	$16.2	8.4%	Rising prevalence, targeted therapy adoption
CDK4/6 Inhibitors Market	$3.4	14.2%	Patent expirations, new approvals

Regional Market Distribution (2023)

Region	Revenue Share	Growth Rate	Notable Trends
North America	45%	9%	Leading in approvals & adoption
Europe	25%	8%	Increasing uptake, reimbursement policies
Asia-Pacific	15%	15%	Rapid growth, expanding healthcare access
Rest of World	15%	10%	Emerging markets, regulatory pathways

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3. Competitive Landscape

Major Players in CDK4/6 Inhibitors

Drug Name	Manufacturer	Approval Year	Indications	Market Share (2023)	Key Differentiators
Abemaciclib (Verzenio®)	Lilly	2017	HR+/HER2− BC	~40%	Continuous dosing, CNS activity
Palbociclib (Ibrance®)	Pfizer	2015	HR+/HER2− BC	~45%	First-to-market, extensive data
Ribociclib (Kisqali®)	Novartis	2017	HR+/HER2− BC	~15%	Favorable safety profile

Market Share Trends

• Abemaciclib's share has increased steadily, driven by its efficacy in heavily pretreated populations and distinct safety profile.
• Competitive strategies include combination regimens, approval for early-stage disease, and expanding indications.

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4. Financial Trajectory and Revenue Projections

Historical Revenue (2017-2022)

Year	Revenue (USD Million)	Growth (%)	Notes
2017	112	-	Initial launch, modest sales
2018	256	128%	Expanded indications, increased uptake
2019	453	76%	Market penetration, label expansions
2020	720	59%	COVID-19 impact managed, new trials success
2021	1,100	52%	Launch in adjuvant setting, stronger demand
2022	1,497	36%	Peak sales, competitive pressures

Forecasted Revenue (2023-2028)

Year	Predicted Revenue (USD Million)	Assumptions
2023	2,100	Increased adoption, new indications, global expansion
2024	2,600	Rising adoption in Asia-Pacific, early-stage approvals
2025	3,200	Full commercialization in adjuvant setting, biosimilar landscape
2026	3,800	Intensified competition, pricing strategies
2027	4,200	Patent cliff approaching, potential biosimilar entry
2028	4,400	Market stabilization, new combination approvals

Revenue Drivers

• Expanded indications (adjuvant, early-stage)
• Geographic growth, especially Asia-Pacific
• Combination therapy approvals
• Competitive pricing and reimbursement policies

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5. Market Dynamics Influencing Growth

Regulatory Environment

• FDA & EMA Approvals: Continuous approval updates expand utilization.
• Pricing and Reimbursement: Positive reimbursement outlook in US and Europe, with challenges in some emerging markets.
• Patent Life & Biosimilars: Patent expiry anticipated around 2025-2026, leading to pricing pressure.

Clinical Trials & Evidence Base

Trial Name	Phase	Indication	Results (2021-2022)	Impact on Market
MonarchE	III	Early-stage BC	Significant DFS benefit	Accelerated adoption
NATALEE (Phase 3)	III	Early BC	Pending data	Potential future driver
Other combination trials	II/III	Metastatic BC, combos	Positive preliminary	Expansion of pipeline

Pricing & Reimbursement Policies

• Generally aligned positively in US, EU, and Japan.
• Key factors include insurer negotiations and value-based pricing models.
• Negotiations in emerging markets influence revenue growth.

Supply Chain & Manufacturing

• Lilly has invested in scalable manufacturing.
• Potential risks include raw material shortages and geopolitical issues.

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6. SWOT Analysis

Strengths	Weaknesses	Opportunities	Threats
Effective in heavily pretreated patients	Patent cliff approaching (2025-2026)	Expanding indications (adjuvant, early)	Biosimilar entry reducing price margins
Favorable safety profile	Competition from Palbociclib, Ribociclib	Market expansion in Asia-Pacific	Pricing pressures, reimbursement constraints
Continuous dosing advantage	Limited data in some combination regimens	New trial data for combination therapies	Regulatory delays in new indications

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7. Comparative Analysis: Abemaciclib vs. Competitors

Aspect	Abemaciclib	Palbociclib	Ribociclib
Approval Year	2017	2015	2017
Dosing Schedule	Continuous	3-weeks-on, 1-week-off	3-weeks-on, 1-week-off
CNS Penetration	Yes	No	No
Safety Profile	Lower neutropenia, more diarrhea	Higher neutropenia but more fatigue	Favorable QTc prolongation profile
Indications Expansion	Yes	Yes	Yes

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8. Future Outlook & Strategic Recommendations

Market Penetration & Growth Opportunities

• Early-Stage Breast Cancer: Ongoing trials like MonarchE could significantly increase market size.
• Combination Regimens: Evidence supports benefits of combining Abemaciclib with other targeted agents.
• Geographic Expansion: Rapid growth in Asia-Pacific through tailored reimbursement strategies.

Potential Challenges

• Patent expiry by 2025 at risk of biosimilar competition.
• Pricing pressures due to biosimilars and cost-containment policies.
• Competitive landscape with new CDK4/6 inhibitors in pipeline.

Strategic Recommendations

• Accelerate approval in early-stage settings to capture larger market share.
• Focus on combination trials to demonstrate superior efficacy.
• Invest in regional licensing and reimbursement negotiations.
• Prepare for biosimilar launch strategies post-patent expiry.

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9. Conclusion

Abemaciclib’s market trajectory reflects a promising blend of clinical efficacy, safety preferences, and expanding indications. While near-term growth remains robust, long-term success hinges on early-stage approvals, biosimilar competition, and strategic expansion into emerging markets. Industry players and Lilly must navigate regulatory landscapes, pricing dynamics, and pipeline innovation to sustain and grow Abemaciclib’s market position.

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Key Takeaways

• Revenue Growth: Historically robust, projected to reach USD 4.4 billion by 2028.
• Market Expansion: Significant potential via early-stage indications and global penetration—especially Asia-Pacific.
• Competitive Positioning: Strengthened by safety profile and CNS activity, yet threatened by biosimilars and patent expiry.
• Strategic Focus: Invest in combination therapies, early-stage approvals, and regional market development.
• Risks & Opportunities: Patent cliff, biosimilar entry, and pipeline advancement remain pivotal.

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FAQs

1. When will Abemaciclib face biosimilar competition, and how will it impact pricing?

Biosimilars are expected around 2025-2026, following patent expiry. This will likely lead to significant price reductions and intensified market competition.

2. Can Abemaciclib be effective in early-stage breast cancer?

Yes, recent Phase 3 trials (e.g., MonarchE) demonstrate improved disease-free survival, poised for regulatory approval expansion into early-stage settings.

3. How does Abemaciclib compare clinically to Palbociclib and Ribociclib?

Abemaciclib offers continuous dosing with CNS activity and a potentially better safety profile regarding neutropenia. Market share is growing due to these attributes.

4. What regional strategies are critical for market growth?

Expanding into Asia-Pacific through tailored reimbursement policies and regulatory pathways, while strengthening presence in North America and Europe, is paramount.

5. What are the primary drivers of Abemaciclib’s revenue growth?

Key drivers include expansion into early and adjuvant indications, global market penetration, combination therapy approvals, and strong clinical trial support.

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References

[1] Eli Lilly and Company. Verzenio NDA and label updates. 2017-2022.
[2] GlobalData. Breast Cancer Therapeutics Market Report. 2023.
[3] FDA and EMA Drug Approvals. 2017-2022.
[4] Market Research Future. CDK4/6 Inhibitors Market Analysis. 2023.
[5] ClinicalTrials.gov. MonarchE and other ongoing trials. Accessed 2023.