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Last Updated: December 24, 2024

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KISQALI Drug Patent Profile


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Which patents cover Kisqali, and what generic alternatives are available?

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-four 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

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Drug patent expirations by year for KISQALI
Drug Prices for KISQALI

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for KISQALI
Generic Entry Date for KISQALI*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
University of Michigan Rogel Cancer CenterPhase 1
AstraZenecaPhase 1/Phase 2
Nationwide Children's HospitalPhase 2

See all KISQALI clinical trials

Pharmacology for KISQALI
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 two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of KISQALI is ⤷  Subscribe.

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 8,324,225 ⤷  Subscribe Y Y ⤷  Subscribe
Novartis KISQALI FEMARA CO-PACK (COPACKAGED) letrozole; ribociclib succinate TABLET;ORAL 209935-001 May 4, 2017 RX Yes Yes 9,868,739 ⤷  Subscribe ⤷  Subscribe
Novartis KISQALI FEMARA CO-PACK (COPACKAGED) letrozole; ribociclib succinate TABLET;ORAL 209935-001 May 4, 2017 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Novartis KISQALI ribociclib succinate TABLET;ORAL 209092-001 Mar 13, 2017 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Novartis KISQALI ribociclib succinate TABLET;ORAL 209092-001 Mar 13, 2017 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

Patent: 4257
Patent: TABLETA DE RIBOCICLIB
Estimated Expiration: ⤷  Subscribe

Australia

Patent: 16248017
Patent: Ribociclib tablet
Estimated Expiration: ⤷  Subscribe

Patent: 19201929
Patent: Ribociclib tablet
Estimated Expiration: ⤷  Subscribe

Patent: 20250190
Patent: Ribociclib tablet
Estimated Expiration: ⤷  Subscribe

Patent: 22215155
Patent: Ribociclib tablet
Estimated Expiration: ⤷  Subscribe

Brazil

Patent: 2017021283
Patent: comprimido de ribociclib
Estimated Expiration: ⤷  Subscribe

Canada

Patent: 82425
Patent: COMPRIME DE RIBOCICLIB (RIBOCICLIB TABLET)
Estimated Expiration: ⤷  Subscribe

Chile

Patent: 17002593
Patent: Tableta de ribociclib.
Estimated Expiration: ⤷  Subscribe

China

Patent: 7530292
Patent: 瑞博西尼片剂 (Ribociclib tablet)
Estimated Expiration: ⤷  Subscribe

Patent: 5554257
Patent: 瑞博西尼片剂 (Ribociclib tablet)
Estimated Expiration: ⤷  Subscribe

Colombia

Patent: 17010510
Patent: Tableta de ribociclib
Estimated Expiration: ⤷  Subscribe

Croatia

Patent: 0230053
Estimated Expiration: ⤷  Subscribe

Denmark

Patent: 83058
Estimated Expiration: ⤷  Subscribe

Ecuador

Patent: 17075052
Patent: Tableta de Ribociclib
Estimated Expiration: ⤷  Subscribe

Eurasian Patent Organization

Patent: 1792290
Patent: ТАБЛЕТКА, СОДЕРЖАЩАЯ РИБОЦИКЛИБ
Estimated Expiration: ⤷  Subscribe

European Patent Office

Patent: 83058
Patent: COMPRIMÉ DE RIBOCICLIB (RIBOCICLIB TABLET)
Estimated Expiration: ⤷  Subscribe

Patent: 97530
Patent: COMPRIMÉ DE RIBOCICLIB (RIBOCICLIB TABLET)
Estimated Expiration: ⤷  Subscribe

Finland

Patent: 83058
Estimated Expiration: ⤷  Subscribe

Hungary

Patent: 61213
Estimated Expiration: ⤷  Subscribe

Japan

Patent: 18514523
Patent: リボシクリブ錠剤
Estimated Expiration: ⤷  Subscribe

Mexico

Patent: 17013350
Patent: COMPRIMIDO DE RIBOCICLIB. (RIBOCICLIB TABLET.)
Estimated Expiration: ⤷  Subscribe

Peru

Patent: 180035
Patent: TABLETA DE RIBOCICLIB
Estimated Expiration: ⤷  Subscribe

Philippines

Patent: 017501820
Patent: RIBOCICLIB TABLET
Estimated Expiration: ⤷  Subscribe

Poland

Patent: 83058
Estimated Expiration: ⤷  Subscribe

Portugal

Patent: 83058
Estimated Expiration: ⤷  Subscribe

Singapore

Patent: 201708084P
Patent: RIBOCICLIB TABLET
Estimated Expiration: ⤷  Subscribe

Slovenia

Patent: 83058
Estimated Expiration: ⤷  Subscribe

South Korea

Patent: 170137101
Patent: 리보시클립 정제
Estimated Expiration: ⤷  Subscribe

Spain

Patent: 38261
Estimated Expiration: ⤷  Subscribe

Taiwan

Patent: 1642864
Patent: RIBOCICLIB tablet
Estimated Expiration: ⤷  Subscribe

Tunisia

Patent: 17000422
Patent: RIBOCICLIB TABLET
Estimated Expiration: ⤷  Subscribe

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
Israel 195086 תרכובות פירולופירימידין ושימושיהן (Pyrrolopyrimidine compounds and their uses) ⤷  Subscribe
Argentina 108179 COMPUESTOS DE PIRROLO[2,3-D]PIRIMIDINA Y SUS USOS PARA EL TRATAMIENTO DE DIVERSOS TIPOS DE CÁNCER POR MEDIO DE LA MODULACIÓN DE LA ACTIVIDAD DE LA CINASA DE PROTEÍNA TIROSINA ⤷  Subscribe
Georgia, Republic of P20115283 PYRROLOPYRIMIDINE COMPOUNDS AND THEIR USES ⤷  Subscribe
San Marino AP200800069 Composti pirrolopirimidinici e loro usi ⤷  Subscribe
Peru 20080263 COMPUESTOS DE PIRROLO-PIRIMIDINA Y SUS USOS ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for KISQALI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2331547 2017/060 Ireland ⤷  Subscribe PRODUCT NAME: RIBOCICLIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/17/1221 20170824
2331547 17C1059 France ⤷  Subscribe PRODUCT NAME: RIBOCICLIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/17/1221 20170824
2331547 2017C/052 Belgium ⤷  Subscribe PRODUCT NAME: KISQALI - RIBOCOCLIB; AUTHORISATION NUMBER AND DATE: EU/1/17/1221 20170824
2331547 664 Finland ⤷  Subscribe
2331547 PA2017039 Lithuania ⤷  Subscribe PRODUCT NAME: RIBOCIKLIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/17/1221 20170822
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

KISQALI Market Analysis and Financial Projection Experimental

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

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