KISQALI Drug Patent Profile

When do Kisqali patents expire, and when can generic versions of Kisqali launch?

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

This drug has one hundred and eighty-seven 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 five 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:	187
US Patents:	9
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	140
Clinical Trials:	35
Patent Applications:	921
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
University of Michigan Rogel Cancer Center	Phase 1
AstraZeneca	Phase 1/Phase 2
Nationwide Children's Hospital	Phase 2

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-seven 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	ribociclib succinate	TABLET;ORAL	209092-001	Mar 13, 2017		RX	Yes	Yes	8,962,630
Novartis	KISQALI	ribociclib succinate	TABLET;ORAL	209092-001	Mar 13, 2017		RX	Yes	Yes	8,415,355		Y	Y
Novartis	KISQALI	ribociclib succinate	TABLET;ORAL	209092-001	Mar 13, 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	12,064,434		Y
Novartis	KISQALI FEMARA CO-PACK (COPACKAGED)	letrozole; ribociclib succinate	TABLET;ORAL	209935-001	May 4, 2017		RX	Yes	Yes	8,962,630
Novartis	KISQALI FEMARA CO-PACK (COPACKAGED)	letrozole; ribociclib succinate	TABLET;ORAL	209935-001	May 4, 2017		RX	Yes	Yes	10,799,506		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

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
Dominican Republic	P2011000057	COMPUESTOS DE PIRROLO-PIRIMIDINA COMO INHIBIDORES DE CDK
Ecuador	SP17075052	Tableta de Ribociclib
Eurasian Patent Organization	016301	ПИРРОЛОПИРИМИДИНЫ И ИХ ПРИМЕНЕНИЕ (PYRROLOPYRIMIDINE COMPOUNDS AND THEIR USES)
New Zealand	572549	PYRROLOPYRIMIDINE COMPOUNDS AND THEIR USES
South Korea	20130140222	PYRROLOPYRIMIDINE COMPOUNDS AS CDK INHIBITORS
Spain	2623133
Tunisia	2011000062	PYRROLOPYRIMIDINE COMPOUNDS OF CDK INHIBITORS

Supplementary Protection Certificates for KISQALI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2331547	1790067-1	Sweden		PRODUCT NAME: RIBOCICLIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REG. NO/DATE: EU/1/17/1221 20170824
2331547	2017/060	Ireland		PRODUCT NAME: RIBOCICLIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/17/1221 20170824
2331547	2017059	Norway		PRODUCT NAME: RIBOSIKLIB ELLER ET; REG. NO/DATE: EU/1/17/1221 20170830
2331547	2017C/052	Belgium		PRODUCT NAME: KISQALI - RIBOCOCLIB; AUTHORISATION NUMBER AND DATE: EU/1/17/1221 20170824
2331547	291 26-2017	Slovakia		PRODUCT NAME: RIBOCIKLIB VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/17/1221 20170824
2331547	664	Finland
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

Market Dynamics and Financial Trajectory for KISQALI (Ribociclib; LEE011)

Introduction to KISQALI

KISQALI, also known as ribociclib (LEE011), is a kinase inhibitor developed by Novartis for the treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Here, we delve into the market dynamics and financial trajectory of this significant drug.

Mechanism of Action and Clinical Use

KISQALI works by inhibiting the CDK4 and CDK6 enzymes, which are crucial for cell cycle progression. When used in combination with antiestrogen therapies such as letrozole or fulvestrant, it has shown increased tumor growth inhibition compared to each drug alone[3][4].

Market Assessment and Forecast

The market for KISQALI in the treatment of ER+ve HER2-ve breast cancer is expected to undergo significant changes due to extensive research and increasing healthcare spending globally. Here are some key points:

• Market Growth: The market scenario for ER+ve HER2-ve breast cancer is set to expand, enabling drug manufacturers to penetrate deeper into the market. This growth is driven by novel therapeutic approaches and increased healthcare spending[1][3][4].
• Competitive Landscape: Other emerging products for ER+ve HER2-ve breast cancer are expected to provide tough competition to KISQALI. Late-stage emerging therapies will significantly impact the market, challenging KISQALI's dominance[1][3][4].
• Forecasted Sales: Detailed market forecasts from 2023 to 2032 indicate a promising trajectory for KISQALI sales. These forecasts will help clients in decision-making regarding their therapeutic portfolios[1][3][4].

Regulatory Milestones and Developmental Activities

• Regulatory Approvals: KISQALI has received several regulatory approvals, including FDA approval and a positive CHMP opinion for HR+/HER2- stage II and III early breast cancer[2].
• Clinical Trials: The drug has undergone extensive clinical trials, with detailed information available on trial interventions, conditions, status, and completion dates. These trials have been pivotal in establishing its efficacy and safety profile[4].
• Development Activities: Continuous research and development activities, including regulatory milestones, are crucial for the current and future development scenario of KISQALI[1][3][4].

Financial Performance of Novartis

Novartis, the manufacturer of KISQALI, has seen significant financial growth driven by the drug's strong performance:

• Sales Growth: In the Q4 2023 financial results, KISQALI showed a sales growth of +75% (constant currency), contributing to Novartis's overall sales growth of +10% (constant currency)[5].
• Operating Income: The strong sales performance of KISQALI, along with other key products like Entresto, Kesimpta, and Pluvicto, has driven Novartis's operating income to increase by +39% (constant currency)[5].
• Net Income and EPS: The net income and EPS have also seen substantial growth, with net income increasing by +62% (constant currency) and EPS growing by +70% (constant currency) to USD 4.13[5].

SWOT Analysis and Analyst Views

• Strengths: KISQALI's strong clinical efficacy, regulatory approvals, and market penetration are key strengths. The drug's ability to inhibit CDK4 and CDK6 enzymes effectively makes it a valuable treatment option[3][4].
• Weaknesses: The emergence of new therapies and potential competition from late-stage emerging therapies are significant challenges. Additionally, the drug's side effects and the need for combination therapy could be drawbacks[1][3][4].
• Opportunities: The expanding market for ER+ve HER2-ve breast cancer treatments and the increasing healthcare spending provide opportunities for growth. Collaborations and licensing agreements can also enhance KISQALI's market position[1][3][4].
• Threats: The competitive landscape, regulatory changes, and patent expirations are potential threats. The launch of new therapies could erode KISQALI's market share if they offer better efficacy or safety profiles[1][3][4].

Late-Stage Emerging Therapies

The market for ER+ve HER2-ve breast cancer is dynamic, with several late-stage emerging therapies under development. These therapies focus on novel approaches to treat and improve the disease condition, posing a significant challenge to KISQALI's market dominance[1][3][4].

Key Takeaways

• Market Expansion: The market for ER+ve HER2-ve breast cancer is expected to expand due to extensive research and increased healthcare spending.
• Regulatory Milestones: KISQALI has received significant regulatory approvals, including FDA approval and positive CHMP opinions.
• Financial Performance: Novartis has seen strong financial growth driven by KISQALI's sales performance.
• Competitive Landscape: Emerging therapies pose a challenge to KISQALI's market position.
• SWOT Analysis: KISQALI has strong clinical efficacy but faces competition from new therapies.

FAQs

What is the mechanism of action of KISQALI?

KISQALI works by inhibiting the CDK4 and CDK6 enzymes, which are crucial for cell cycle progression[3][4].

What are the key regulatory milestones for KISQALI?

KISQALI has received FDA approval and a positive CHMP opinion for HR+/HER2- stage II and III early breast cancer[2].

How has KISQALI contributed to Novartis's financial performance?

KISQALI has shown a sales growth of +75% (constant currency), significantly contributing to Novartis's overall sales and operating income growth[5].

What are the potential challenges to KISQALI's market dominance?

Emerging therapies and late-stage products pose a significant challenge to KISQALI's market position. Regulatory changes and patent expirations are also potential threats[1][3][4].

What is the forecasted market scenario for KISQALI?

The market for KISQALI is expected to grow, with detailed forecasts indicating a promising sales trajectory from 2023 to 2032[1][3][4].

Sources

1. United States KISQALI (Ribociclib; LEE011) Drug Market Insights and Forecasts Report - GlobeNewswire
2. Novartis continues strong momentum in Q3 with 10% sales growth - Novartis
3. KISQALI Drug Insight Market Forecast - DelveInsight
4. KISQALI Drug Insight and Market Forecast – 2032 - MarketResearch.com
5. Novartis Financial Results Q4 2023 - Novartis