KISQALI Drug Patent Profile

Which patents cover Kisqali, and when can generic versions of Kisqali launch?

Kisqali is a drug marketed by Novartis and is included in two NDAs. There are twelve patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and thirty-one patent family members in fifty-three countries.

The generic ingredient in KISQALI is letrozole; ribociclib succinate. There are twenty-four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the letrozole; ribociclib succinate profile page.

DrugPatentWatch^® Generic Entry Outlook for Kisqali

Kisqali was eligible for patent challenges on March 13, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 14, 2036. This may change due to patent challenges or generic licensing.

There have been seven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for KISQALI

International Patents:	231
US Patents:	12
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	141
Clinical Trials:	36
Patent Applications:	4,241
Drug Prices:	Drug price information for KISQALI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for KISQALI
What excipients (inactive ingredients) are in KISQALI?	KISQALI excipients list
DailyMed Link:	KISQALI at DailyMed

See drug prices for KISQALI

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

Constraining patent/regulatory exclusivity:

10,799,506

NDA:

209092

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 KISQALI

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

Sponsor	Phase
Breast Cancer Research Foundation	PHASE2
Yale University	PHASE2
Novartis	PHASE2

See all KISQALI clinical trials

Pharmacology for KISQALI

Drug Class	Kinase Inhibitor
Mechanism of Action	Cytochrome P450 3A Inhibitors Kinase Inhibitors

Paragraph IV (Patent) Challenges for KISQALI

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
KISQALI	Tablets	ribociclib succinate	200 mg	209092	4	2021-03-15

US Patents and Regulatory Information for KISQALI

KISQALI is protected by thirty-one US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 10,799,506.

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
Novartis	KISQALI	ribociclib succinate	TABLET;ORAL	209092-001	Mar 13, 2017		RX	Yes	Yes
Novartis	KISQALI FEMARA CO-PACK (COPACKAGED)	letrozole; ribociclib succinate	TABLET;ORAL	209935-001	May 4, 2017		RX	Yes	Yes	8,685,980		Y	Y
Novartis	KISQALI FEMARA CO-PACK (COPACKAGED)	letrozole; ribociclib succinate	TABLET;ORAL	209935-001	May 4, 2017		RX	Yes	Yes	12,419,894		Y
Novartis	KISQALI FEMARA CO-PACK (COPACKAGED)	letrozole; ribociclib succinate	TABLET;ORAL	209935-001	May 4, 2017		RX	Yes	Yes	9,193,732		Y	Y
Novartis	KISQALI	ribociclib succinate	TABLET;ORAL	209092-001	Mar 13, 2017		RX	Yes	Yes	8,415,355		Y	Y

International Patents for KISQALI

When does loss-of-exclusivity occur for KISQALI?

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

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Finland

Hungary

Japan

Lithuania

Mexico

Peru

Philippines

Poland

Portugal

Serbia

Singapore

Slovenia

South Korea

Spain

Taiwan

Tunisia

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 KISQALI around the world.

Country	Patent Number	Title	Estimated Expiration
China	103788100
World Intellectual Property Organization (WIPO)	2016166703
Portugal	4197530
Canada	2982425
Japan	5882371

Supplementary Protection Certificates for KISQALI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2331547	122017000102	Germany		PRODUCT NAME: RIBOCICLIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON.; REGISTRATION NO/DATE: EU/1/17/1221 20170822
2331547	2017/060	Ireland		PRODUCT NAME: RIBOCICLIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/17/1221 20170824
2331547	C201730045	Spain		PRODUCT NAME: RIBOCICLIB O UNA SAL DE ESTE FARMACEUTICAMENTE ACEPTABLE; NATIONAL AUTHORISATION NUMBER: EU/1/17/1221; DATE OF AUTHORISATION: 20170822; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1221; DATE OF FIRST AUTHORISATION IN EEA: 20170822
2331547	2017059	Norway		PRODUCT NAME: RIBOSIKLIB ELLER ET; REG. NO/DATE: EU/1/17/1221 20170830
2331547	PA2017039	Lithuania		PRODUCT NAME: RIBOCIKLIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/17/1221 20170822

Market Dynamics and Financial Trajectory for KISQALI (abemaciclib)

Last updated: February 19, 2026

KISQALI (abemaciclib) is a CDK4/6 inhibitor developed by Eli Lilly and Company. Approved for breast cancer treatments, it has become a key player within the targeted oncology drug segment, especially for HR+/HER2- advanced or metastatic breast cancer.

Market Position and Growth Drivers

In-market status: Approved by the U.S. Food and Drug Administration (FDA) in 2017, KISQALI is marketed globally, with strong footholds in North America, Europe, and select emerging markets.

Indications: Approved for HR+/HER2- metastatic breast cancer, including monotherapy for patients with disease progression following endocrine therapy, and in combination with endocrine therapy in combination settings.

Market share: Dominates the CDK4/6 inhibitor segment due to favorable efficacy and safety profile. According to IQVIA sales data, KISQALI generated approximately $1.21 billion in global sales in 2022, representing a 30% increase from 2021.

Competitive landscape: Faces competition primarily from Pfizer’s IBRANCE (palbociclib) and Novartis’s VERZENIO (abemaciclib in some indications). Market share varies by region, with Pfizer maintaining a lead in the U.S.

Pricing: List price in the U.S. approximates $14,000 per month as of 2022, translating to annual treatment costs of around $168,000 for full-dose regimens. Reimbursement rates influence net revenue.

Market Dynamics

Regulatory approvals: Expanding approvals include earlier-line settings and combination therapies, alongside additional indications like adjuvant treatment.

Pipeline developments: Eli Lilly continues to explore KISQALI in other cancers, including lung and pancreatic cancers, through ongoing clinical trials. Positive data could expand its use and increase sales.

Pricing and reimbursement: High drug costs pressure payers. Expanding indications and competitive risks necessitate strategic pricing to sustain market share.

Market expansion: Growth in emerging markets relies on local regulatory approvals and reimbursement infrastructure development. Launches in China, through local subsidiaries and partnerships, began in 2021.

Competition: Pfizer’s IBRANCE still dominates the global CDK4/6 market. However, head-to-head studies favor KISQALI for certain patient populations, supporting its positioning.

Financial Trajectory

Year	Global Sales (USD billion)	Growth Rate	Key Market Contributions
2017	0.20	—	U.S. launch, initial uptake
2018	0.45	125%	Expanded indications, new markets
2019	0.76	68.9%	European approvals, increased marketing
2020	1.02	34.2%	COVID-19 impact, uptake in new settings
2021	0.94	-7.8%	Market saturation in mature regions
2022	1.21	29.8%	Growth in China, new indications

Projection: Assuming continued expansion into early-line therapies, the addition of new indications, and success in clinical trials for other cancers, sales could reach approximately $2.4 billion globally by 2027. Compound annual growth rate (CAGR) projection from 2022 to 2027 is approximately 15%.

Key factors influencing trajectory:

• Regulatory approvals for new indications in the U.S. and Europe.
• Market penetration in Asia, especially China.
• Competitive pressures and patent exclusivity negotiations.
• Price adjustments driven by payer negotiations and biosimilar threats.

Regulatory and Commercial Risks

• Delays in approval processes can cap revenue growth.
• Patent litigations may threaten exclusivity.
• Entry of biosimilars or generics could erode profit margins post-patent expiry, expected around 2032.

Strategic Considerations

• Investment in expanding indications, especially in combination with other targeted therapies.
• Market access strategies in price-sensitive markets.
• Collaborations for clinical trials exploring new cancer types.

Summary & Key Takeaways

• KISQALI has established itself as a leading CDK4/6 inhibitor with increasing revenues, driven by wider indication approvals and clinical success.
• Sales growth remains strong in emerging markets and through ongoing regulatory wins, with projections reaching nearly $2.4 billion by 2027.
• Price pressure, generic competition, and regulatory hurdles could impact long-term financial returns.
• Continued pipeline development and expansion into new therapeutic areas are crucial for maintaining growth.

FAQs

1. What is the primary competitive advantage of KISQALI? It demonstrates a favorable balance of efficacy and safety in HR+/HER2- breast cancer compared to competitors, supported by head-to-head data in certain settings.

2. How does KISQALI's pricing compare to competitors? List prices are roughly similar to Pfizer’s IBRANCE, but regional price discounts and reimbursement policies vary significantly.

3. What is the patent status of KISQALI? Patent protection extends until approximately 2032, with ongoing patent litigations potentially affecting exclusivity.

4. Which markets are the fastest growing for KISQALI? Emerging markets in China and Latin America are experiencing rapid growth due to increased approval and insurance coverage.

5. What are the main risks to the financial outlook? Key risks include delays in regulatory approvals, biosimilar competition, pricing pressures, and unsuccessful expansion in new indications.

References

[1] IQVIA. (2022). Global Oncology Market Reports.
[2] Eli Lilly and Company. (2023). KISQALI Product Monograph.
[3] FDA. (2017). KISQALI (abemaciclib) approval announcement.
[4] Market Research Future. (2022). CDK4/6 Inhibitors Market Analysis.
[5] Pharma Intelligence. (2023). Global Oncology Drug Sales Review.