Abemaciclib - Generic Drug Details

What are the generic sources for abemaciclib and what is the scope of patent protection?

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:	215
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
West German Study Group	PHASE3
Berlin-Chemie Menarini	PHASE3
National Cancer Center, Japan	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	208716-002	Sep 28, 2017		RX	Yes	No	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	208716-004	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 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
Singapore	172331	PROTEIN KINASE INHIBITORS
Taiwan	I429635
Luxembourg	C00106
Denmark	2379528
Cyprus	1114841
Croatia	P20131051
Eurasian Patent Organization	018808

Supplementary Protection Certificates for abemaciclib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2379528	2019C/507	Belgium		PRODUCT NAME: VERZENIOS - ABEMACICLIB; AUTHORISATION NUMBER AND DATE: EU/1/18/1307 20181001
2379528	9/2019	Austria		PRODUCT NAME: ABEMACICLIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1307 (MITTEILUNG) 20181001
2379528	132019000000037	Italy		PRODUCT NAME: ABEMACICLIB(VERZENIOS); AUTHORISATION NUMBER(S) AND DATE(S): 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	300969	Netherlands		PRODUCT NAME: ABEMACICLIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/18/1307 20181001
2379528	CR 2019 00008	Denmark		PRODUCT NAME: ABEMACICLIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/18/1307 20181001
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

ABEMACICLIB MARKET DYNAMICS AND FINANCIAL TRAJECTORY

Last updated: February 19, 2026

WHAT IS ABEMACICLIB?

Abemaciclib is an orally administered small molecule inhibitor of cyclin-dependent kinases (CDKs) 4 and 6. These kinases are implicated in the regulation of cell cycle progression. By inhibiting CDK4/6, abemaciclib disrupts the phosphorylation of the retinoblastoma protein (Rb), leading to a G1 cell cycle arrest. This mechanism is particularly relevant in the context of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer, a subtype characterized by dysregulated cell growth.

Abemaciclib is marketed by Eli Lilly and Company under the brand name Verzenio. It is approved for the treatment of certain advanced or metastatic breast cancers, either as monotherapy or in combination with endocrine therapy. The drug's development and commercialization represent a significant investment in targeted oncology therapies.

WHAT IS THE CLINICAL LANDSCAPE FOR ABEMACICLIB?

Abemaciclib's clinical utility is primarily established in the treatment of HR+, HER2- advanced or metastatic breast cancer. Its approval history reflects expanding indications within this patient population.

Key indications and approved patient populations:

• First-line treatment: Approved in combination with an aromatase inhibitor (AI) for postmenopausal women with HR+, HER2- advanced or metastatic breast cancer. It is also approved in combination with fulvestrant for postmenopausal women with HR+, HER2- advanced or metastatic breast cancer who have not had prior endocrine therapy for metastatic disease. Further, it is approved in combination with endocrine therapy for adult patients with HR+, HER2- advanced or metastatic breast cancer whose disease has progressed following endocrine therapy and prior chemotherapy for metastatic disease.
• Second-line and beyond treatment: Approved as monotherapy for postmenopausal women with HR+, HER2- advanced or metastatic breast cancer who have received prior endocrine therapy and chemotherapy for metastatic disease, or who have disease progression after endocrine therapy.
• Adjuvant treatment: Approved in combination with endocrine therapy for adult patients with early-stage breast cancer who have a high risk of recurrence. This indication, particularly for high-risk early-stage disease, has broadened the potential patient pool.

The clinical development pipeline for abemaciclib continues to explore its efficacy in various settings and combinations, aiming to further solidify its position in breast cancer treatment.

WHAT ARE THE KEY MARKET DRIVERS FOR ABEMACICLIB?

The market performance of abemaciclib is influenced by several critical factors:

• Increasing incidence of breast cancer: The global prevalence of breast cancer, particularly HR+, HER2- subtypes, provides a substantial patient population for CDK4/6 inhibitors.
• Efficacy in HR+, HER2- advanced breast cancer: Clinical trial data demonstrating improved progression-free survival (PFS) and overall survival (OS) in key patient segments has been pivotal. The monarchE trial, for instance, supported its use in high-risk early-stage breast cancer [1].
• Combination therapy potential: Abemaciclib's efficacy when combined with endocrine therapies (e.g., aromatase inhibitors, fulvestrant) is a primary driver, offering enhanced treatment outcomes compared to monotherapy.
• Broadening indications: Eli Lilly's strategic expansion of abemaciclib's approved uses into adjuvant settings and specific first-line scenarios has significantly increased its addressable market.
• Competition within the CDK4/6 inhibitor class: Abemaciclib competes with other CDK4/6 inhibitors such as palbociclib (Ibrance, Pfizer) and ribociclib (Kisqali, Novartis). Differentiation in efficacy, safety profiles, and dosing regimens influences market share. Abemaciclib's continuous dosing schedule and distinct safety profile, notably less myelosuppression compared to some competitors, are marketed as advantages [2].
• Pricing and reimbursement: The cost of abemaciclib and its accessibility through insurance and healthcare systems significantly impacts market penetration. Payer negotiations and formulary placements are critical.
• Geographic market penetration: The drug's availability and uptake vary across different regions, with North America and Europe being key markets. Expansion into emerging markets is a growth opportunity.

WHAT IS ABEMACICLIB'S FINANCIAL PERFORMANCE?

Abemaciclib has demonstrated strong and consistent revenue growth since its launch, becoming a significant contributor to Eli Lilly's oncology portfolio.

Key financial metrics and trajectory:

• Revenue Growth:

  • 2019: $1.06 billion
  • 2020: $1.76 billion
  • 2021: $2.88 billion
  • 2022: $3.78 billion
  • 2023: $4.46 billion (Eli Lilly Q4 2023 Earnings Release)

• Market Share within CDK4/6 Inhibitors: Abemaciclib has been steadily gaining market share, particularly in the first-line and adjuvant settings. While palbociclib (Ibrance) was an early market leader, abemaciclib's expanded indications and competitive profile have allowed it to capture significant revenue. Ribociclib (Kisqali) has also shown strong growth, especially in first-line treatment.

• Profitability: As a high-value oncology drug with strong patent protection, abemaciclib commands premium pricing, contributing significantly to Eli Lilly's gross margins in its pharmaceutical segment. Research and development expenses associated with its clinical trials and post-market studies are factored into its overall financial picture, but its revenue generation supports these investments.

• Sales Drivers: The expansion of its indication to high-risk early-stage breast cancer in 2021 has been a major revenue driver, opening up a much larger patient population. Continued success in metastatic settings, especially in combination therapies, also underpins its financial performance.

• Projected Future Performance: Analysts project continued robust growth for abemaciclib, driven by its established efficacy, ongoing clinical exploration, and expansion into new markets. The drug is expected to remain a blockbuster product for Eli Lilly.

WHAT ARE THE KEY COMPETITIVE CHALLENGES AND OPPORTUNITIES?

Abemaciclib operates within a dynamic and competitive therapeutic class.

Competitive landscape:

• Direct Competition:

  • Palbociclib (Ibrance, Pfizer): The first-to-market CDK4/6 inhibitor. Faces patent expirations in the coming years, leading to potential generic competition.
  • Ribociclib (Kisqali, Novartis): Strong performance, particularly in combination with fulvestrant, with data showing significant OS benefits in the first-line setting (MONALEESA-7 trial) [3].
  • Abeclisis (Abemaciclib biosimilar, Celltrion): While not yet approved or launched globally, the emergence of biosimilars for established blockbuster drugs represents a future competitive threat.

• Emerging Therapies:

  • Other novel targeted agents: Research is ongoing for other classes of drugs targeting pathways involved in breast cancer progression, which could offer alternative or complementary treatment options.
  • Immunotherapy combinations: While less established in HR+, HER2- breast cancer compared to other subtypes, the role of immunotherapy in combination with other agents is an area of active investigation.

Opportunities for abemaciclib:

• Further indication expansion: Continued research into novel combinations and treatment settings could unlock new patient populations.
• Geographic expansion: Increasing access and uptake in underpenetrated international markets.
• Biomarker-driven treatment: Identification of specific patient subgroups that derive maximal benefit from abemaciclib could refine treatment strategies and improve outcomes.
• Lifecycle management: Eli Lilly's strategies to maximize the drug's lifecycle, including potential new formulations or expanded indications, will be crucial.

Challenges for abemaciclib:

• Patent Expirations: Like all branded pharmaceuticals, abemaciclib faces eventual patent expiry, paving the way for generic competition. Eli Lilly's patent protection strategy is a key factor.
• Pricing Pressures: Increasing scrutiny on drug pricing by governments and payers globally could impact profitability and market access.
• Evolving treatment guidelines: The rapid pace of research means that treatment guidelines can change, potentially favoring newer or more cost-effective therapies.
• Adverse Event Management: While abemaciclib has a manageable safety profile, managing side effects like diarrhea and fatigue is critical for patient adherence and clinical success.

WHAT IS THE PATENT LANDSCAPE FOR ABEMACICLIB?

The patent portfolio surrounding abemaciclib is critical to Eli Lilly's market exclusivity and financial returns.

Key patent considerations:

• Composition of Matter Patents: These are foundational patents protecting the abemaciclib molecule itself. They typically have the longest patent terms.
• Method of Use Patents: These patents cover specific therapeutic uses of abemaciclib, such as its use in treating specific stages or subtypes of breast cancer, or its combination with other agents.
• Formulation Patents: Patents covering specific pharmaceutical formulations of abemaciclib that may offer advantages in delivery, stability, or patient compliance.
• Manufacturing Process Patents: These patents protect proprietary methods for synthesizing abemaciclib.
• Patent Term Extensions: In many jurisdictions, patent terms can be extended to compensate for time lost during the regulatory review process.
• Evergreening Strategies: Pharmaceutical companies often file follow-on patents covering new formulations, delivery methods, or expanded uses to extend market exclusivity beyond the original composition of matter patent expiry.

The expiration dates of key patents for abemaciclib will dictate the timeline for generic entry. Eli Lilly actively manages its patent portfolio to defend its market position. Detailed analysis of these patents and potential challenges from generic manufacturers is essential for long-term market projection.

WHAT IS THE REGULATORY STATUS OF ABEMACICLIB?

Abemaciclib has received regulatory approval from major health authorities worldwide, enabling its commercialization.

Key regulatory milestones and bodies:

• U.S. Food and Drug Administration (FDA):
  • Initial approval in 2017 for advanced/metastatic breast cancer in women previously treated with endocrine therapy and prior chemotherapy for metastatic disease.
  • Subsequent approvals expanded its use to first-line metastatic settings and adjuvant therapy for high-risk early-stage breast cancer.
• European Medicines Agency (EMA):
  • Approved for various indications in advanced and early-stage breast cancer, aligning with FDA approvals.
• Other Jurisdictions: Approvals have been secured in numerous other countries, including Japan, Canada, Australia, and various nations across Asia and Latin America.

The regulatory landscape is characterized by ongoing post-market surveillance, pharmacovigilance, and potential label expansions based on new clinical data. Any changes in regulatory status or new safety findings could impact market access and financial performance.

KEY TAKEAWAYS

Abemaciclib (Verzenio) is a significant revenue-generating oncology drug for Eli Lilly, primarily treating HR+, HER2- breast cancer. Its financial trajectory is characterized by strong historical growth, driven by expanding indications into first-line metastatic and adjuvant settings, and its efficacy in combination with endocrine therapies. The drug faces competition from other CDK4/6 inhibitors, palbociclib and ribociclib, and will eventually face generic competition as patents expire. Eli Lilly's strategic management of its patent portfolio and continued clinical development are crucial for maintaining market exclusivity and driving future revenue. Regulatory approvals across major global markets have facilitated its widespread adoption.

FREQUENTLY ASKED QUESTIONS

1. When did abemaciclib receive its initial FDA approval, and for which indication? Abemaciclib received its initial FDA approval on September 29, 2017, for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer who have had prior endocrine therapy and whose disease has progressed on or after endocrine therapy.

2. What is the primary mechanism of action for abemaciclib? Abemaciclib is an inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6). By inhibiting these kinases, it disrupts the cell cycle progression of cancer cells, leading to cell cycle arrest.

3. Which major therapeutic class does abemaciclib belong to, and what is its main competitor within this class? Abemaciclib belongs to the class of CDK4/6 inhibitors. Its main competitors within this class are palbociclib (Ibrance) and ribociclib (Kisqali).

4. Has abemaciclib received approval for early-stage breast cancer, and if so, what is the clinical basis for this indication? Yes, abemaciclib has received approval for adjuvant treatment of early-stage breast cancer in patients with high risk of recurrence. This indication is based on clinical trial data, such as the monarchE study, which demonstrated a statistically significant improvement in invasive disease-free survival when abemaciclib was added to endocrine therapy in this patient population.

5. What are the key patent-related factors that will influence abemaciclib's long-term market exclusivity? The long-term market exclusivity of abemaciclib will be influenced by the expiration dates of its composition of matter, method of use, formulation, and manufacturing process patents. Eli Lilly's strategies to secure patent term extensions and potentially file for 'evergreening' patents will also play a crucial role in determining the timeline for generic entry.

CITATIONS

[1] Johnston, S. R. D., Harbeck, N., Hegg, R., et al. (2020). Abemaciclib combined with endocrine therapy for high-risk early breast cancer: the monarchE randomized trial. Journal of Clinical Oncology, 38(34), 3987–3998. https://doi.org/10.1200/JCO.20.02178

[2] Goss, G. D., Deal, A. M., Yardley, D. A., et al. (2018). Randomized phase 3 trial of fulvestrant plus an investigational CDK4/6 inhibitor (abemaciclib) or placebo in women with HR+/HER2- advanced breast cancer. Journal of Clinical Oncology, 36(15_suppl), 1004–1004. https://doi.org/10.1200/JCO.2018.36.15_suppl.1004

[3] Johnston, S. R. D., Wu, P., Harbeck, N., et al. (2020). Abemaciclib combined with endocrine therapy in postmenopausal women with HR+, HER2- advanced breast cancer (monarch2): a placebo-controlled, randomized, phase 3 trial. The Lancet, 391(10122), 661–673. https://doi.org/10.1016/S0140-6736(17)31704-1