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 ten patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and eighty-nine 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:	189
US Patents:	10
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
Novartis	PHASE2
Breast Cancer Research Foundation	PHASE2
Yale University	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 twenty-eight 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 FEMARA CO-PACK (COPACKAGED)	letrozole; ribociclib succinate	TABLET;ORAL	209935-001	May 4, 2017		RX	Yes	Yes	10,799,506		Y
Novartis	KISQALI FEMARA CO-PACK (COPACKAGED)	letrozole; ribociclib succinate	TABLET;ORAL	209935-001	May 4, 2017		RX	Yes	Yes	9,868,739
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	8,324,225		Y	Y
Novartis	KISQALI	ribociclib succinate	TABLET;ORAL	209092-001	Mar 13, 2017		RX	Yes	Yes

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

Mexico

Peru

Philippines

Poland

Portugal

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
Malaysia	164274	SALT(S) OF 7-CYCLOPENTYL-2-(5-PIPERAZIN-1-YL-PYRIDIN-2-YLAMINO)-7H-PYRROLO[2,3-D]PYRIMIDINE-6-CARBOXYLIC ACID DIMETHYLAMIDE AND PROCESSES OF MAKING THEREOF
European Patent Office	2638030	SEL SUCCINAT DU DIMETHYLAMIDE DE L'ACIDE 7-CYCLOPENTYL-2-(5-PIPERAZIN-1-YLPYRIDIN-2-YLAMINO)-7H-PYRROLO[2,3-D]PYRIMIDINE-6-CARBOXYLIQUE ET LEURS PROCEDES DE FABRICATION (SUCCINATE SALT OF 7-CYCLOPENTYL-2 -(5-PIPERAZIN-1-YL-PYRIDIN-2-YLAMINO)-7H-PYRROLO[2,3-D]PYRIMIDINE-6-CARBOXYLIC ACID DIMETHYLAMIDE AND PROCESSES OF MAKING THEREOF)
Tunisia	2017000422
Philippines	12017501820
Eurasian Patent Organization	201100355	ПИРРОЛОПИРИМИДИНЫ И ИХ ПРИМЕНЕНИЕ

Supplementary Protection Certificates for Kisqali

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2331547	SPC/GB17/074	United Kingdom		PRODUCT NAME: RIBOCICLIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/17/1221/001-012 20170824; UK PLGB 00101/1100 20170824
2331547	C20170039 00245	Estonia		PRODUCT NAME: RIBOTSIKLIIB;REG NO/DATE: EU/1/17/1221 24.08.2017
2331547	CR 2017 00060	Denmark		PRODUCT NAME: RIBOCICLIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/17/1221 20170824
2331547	122017000102	Germany		PRODUCT NAME: RIBOCICLIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON.; REGISTRATION NO/DATE: EU/1/17/1221 20170822
2331547	2017059	Norway		PRODUCT NAME: RIBOSIKLIB ELLER ET; REG. NO/DATE: EU/1/17/1221 20170830

Market Dynamics and Financial Trajectory for KISQALI (Ribociclib)

Last updated: August 30, 2025

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Introduction

KISQALI (ribociclib) has emerged as a significant player in the targeted oncology space, particularly in the treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer. Developed by Novartis, KISQALI’s market entry aligns with contemporary trends favoring personalized cancer therapy. Analyzing the market dynamics and financial trajectory offers insights into its commercial potential, competitive landscape, and future growth.

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Market Overview and Therapeutic Landscape

The global breast cancer therapeutics market was valued at approximately USD 13.2 billion in 2022 and is projected to reach USD 20.5 billion by 2030, reflecting a compound annual growth rate (CAGR) of around 6%. The rise stems from increased prevalence, advancements in targeted therapies, and a shift toward personalized treatment approaches [1].

KISQALI, as a selective CDK4/6 inhibitor, addresses a critical unmet need in HR+/HER2- breast cancer—a subgroup representing about 70% of breast cancer cases worldwide. Previously, treatment options were limited; thus, the drug's approval and subsequent adoption significantly influence its commercial trajectory.

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Market Dynamics Influencing KISQALI

1. Competitive Landscape

KISQALI’s primary competitors include Pfizer’s IBRANCE (palbociclib), Eli Lilly’s Verzenio (abi­raciclib), and recently, AstraZeneca’s Enhertu (trastuzumab deruxtecan) in various breast cancer niches. Among these, IBRANCE remains the market leader, owing to its earlier market entry and robust clinical data.

However, KISQALI has demonstrated non-inferiority in pivotal trials and benefits from once-daily dosing and a favorable side-effect profile, providing competitive advantages. The patent expiration timelines for key competitors influence KISQALI’s market share expansion and generic exposure.

2. Regulatory Approvals and Label Expansion

Since its initial approval in 2017 for postmenopausal women with HR+/HER2- advanced breast cancer, KISQALI has gained approvals for additional indications, including:

• First-line Setting: Approved in combination with an aromatase inhibitor.
• Adjuvant & Early Breast Cancer: Pending data could expand its scope.
• Male Breast Cancer Treatment: Emerging evidence may broaden use.

These approvals enhance KISQALI’s addressable market, with regulatory bodies like the FDA, EMA, and other regional authorities playing pivotal roles.

3. Market Penetration and Adoption

Physician acceptance hinges on clinical efficacy, safety profile, and convenience. KISQALI’s once-daily, oral administration enhances patient adherence. Moreover, real-world data and comparative effectiveness studies reinforce its utility, leading to increasing prescriptions.

4. Pricing, Reimbursement, and Market Access

KISQALI commands premium pricing aligned with innovative oncology agents. Negotiations with healthcare payers, especially in cost-conscious markets, can influence its uptake. Novartis’s strategy involves demonstrating value through clinical benefits and pharmacoeconomic analyses to secure favorable reimbursement decisions.

5. Clinical Development Pipeline and Upcoming Data

Ongoing trials exploring combination regimens, biomarkers for response prediction, and new indications will shape the future pipeline. Positive phase III results can serve as catalysts for deferring market saturation and fostering new revenue streams.

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Financial Trajectory and Revenue Forecast

1. Revenue Performance and Growth Drivers

KISQALI’s sales demonstrated rapid growth following its launch, reaching USD 1.2 billion globally in 2021, according to Novartis reports, with further gains anticipated driven by:

• Expansion into earlier lines of therapy.
• Increased adoption in developed markets (U.S., EU).
• Emerging markets gaining approval.
• Lifecycle management via new combinations.

2. Market Penetration & Forecasts

Analysts project KISQALI’s CAGR of approximately 10-12% over the next five years, driven by:

• Broader regulatory approvals.
• Competitive differentiation favoring its safety profile.
• Increased pipeline approvals and companion diagnostics.

These factors could elevate annual sales to upwards of USD 2.5 billion by 2027, with some estimates reaching USD 3 billion depending on market access success and pipeline progress [2].

3. Cost Structure and R&D Investment

Novartis continues investing in R&D to sustain pipeline growth and extend KISQALI’s indications. Cost efficiencies and strategic collaborations are pivotal to sustaining healthy margins amidst mounting competition.

4. Risks and Challenges

Market penetration could face hurdles from:

• Patent cliffs and biosimilar entry for existing competitors.
• Pricing pressures from payers.
• Emergence of novel therapeutic modalities, such as antibody-drug conjugates and immunotherapies.

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Regulatory and Market Risks

Regulatory delays or unfavorable trial outcomes could threaten expansion plans. Additionally, shifting healthcare policies and reimbursement landscapes—particularly in cost-sensitive nations—pose risks to revenue growth.

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Conclusion

KISQALI’s success hinges on a confluence of escalating clinical adoption, pipeline advancements, strategic market access, and competitive positioning. While current trajectory indicates robust growth, market pressures and competitive dynamics necessitate continual innovation and strategic agility from Novartis.

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Key Takeaways

• Market Size & Growth: KISQALI is positioned in a rapidly expanding segment of breast cancer therapy, with projections indicating sustained double-digit growth.
• Competitive Edge: Its favorable efficacy and side-effect profile support continued adoption despite strong competition.
• Pipeline & Indications Expansion: Regulatory approvals for additional indications will be primary growth catalysts.
• Market Access & Pricing: Premium pricing strategies require continuous demonstration of value to optimize reimbursement scenarios.
• Risks & Challenges: Patent expiration, biosimilars, and evolving treatment paradigms remain key risks that may impact long-term revenues.

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FAQs

1. What factors contribute to KISQALI’s market competitiveness?
Its oral administration, demonstrated efficacy, favorable safety profile, and expanding regulatory approvals underpin its competitive position against other CDK4/6 inhibitors.

2. How does KISQALI’s clinical trial data influence its market trajectory?
Positive trial outcomes, especially in first-line settings and combination therapies, bolster clinician confidence and regulatory approval prospects, driving sales growth.

3. What is the outlook for KISQALI in emerging markets?
Regulatory approvals and price negotiations in markets like China, India, and Latin America are anticipated to expand volume sales, though market penetration may be slower due to access barriers.

4. How might biosimilar entrants impact KISQALI?
While biosimilars typically enter biologic markets, the potential for generic or biosimilar competitors post-patent expiry could pressure prices and market share.

5. What are the strategic moves for Novartis to sustain KISQALI’s growth?
Continued pipeline development, expanding indications, improving access strategies, and building collaborations for combination therapies are key strategies.

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Sources

1. GlobalData. "Breast Cancer Therapeutics Market Analysis." 2022.
2. Novartis Annual Report 2022.
3. EvaluatePharma. "KISQALI Market Forecasts." 2023.