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Last Updated: December 22, 2024

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KISQALI FEMARA CO-PACK (COPACKAGED) Drug Patent Profile


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Which patents cover Kisqali Femara Co-pack (copackaged), and when can generic versions of Kisqali Femara Co-pack (copackaged) launch?

Kisqali Femara Co-pack (copackaged) is a drug marketed by Novartis and is included in one NDA. 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 FEMARA CO-PACK (COPACKAGED) 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 Femara Co-pack (copackaged)

Kisqali Femara Co-pack (copackaged) 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 FEMARA CO-PACK (COPACKAGED)
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for KISQALI FEMARA CO-PACK (COPACKAGED)
Generic Entry Date for KISQALI FEMARA CO-PACK (COPACKAGED)*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET, 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.

Paragraph IV (Patent) Challenges for KISQALI FEMARA CO-PACK (COPACKAGED)
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
KISQALI FEMARA CO-PACK (COPACKAGED) Tablets letrozole; ribociclib succinate 200 mg and 2.5 mg 209935 4 2021-03-15

US Patents and Regulatory Information for KISQALI FEMARA CO-PACK (COPACKAGED)

KISQALI FEMARA CO-PACK (COPACKAGED) is protected by fifteen US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of KISQALI FEMARA CO-PACK (COPACKAGED) 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 8,962,630 ⤷  Subscribe ⤷  Subscribe
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 ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Novartis KISQALI FEMARA CO-PACK (COPACKAGED) letrozole; ribociclib succinate TABLET;ORAL 209935-001 May 4, 2017 RX Yes Yes 8,685,980 ⤷  Subscribe Y Y ⤷  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 FEMARA CO-PACK (COPACKAGED)

When does loss-of-exclusivity occur for KISQALI FEMARA CO-PACK (COPACKAGED)?

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 FEMARA CO-PACK (COPACKAGED) around the world.

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2007140222 ⤷  Subscribe
Russian Federation 2013126112 СОЛЬ (СОЛИ) ДИМЕТИЛАМИДА 7-ЦИКЛОПЕНТИЛ-2-(5-ПИПЕРАЗИН-1-ИЛ-ПИРИДИН-2-ИЛАМИНО)-7Н-ПИРРОЛО[2,3-d]ПИРИМИДИН-6-КАРБОНОВОЙ КИСЛОТЫ И СПОСОБЫ ИХ ПОЛУЧЕНИЯ ⤷  Subscribe
South Korea 20110052713 PYRROLOPYRIMIDINE COMPOUNDS AS CDK INHIBITORS ⤷  Subscribe
Australia 2011326620 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 ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for KISQALI FEMARA CO-PACK (COPACKAGED)

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 291 26-2017 Slovakia ⤷  Subscribe PRODUCT NAME: RIBOCIKLIB VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/17/1221 20170824
2331547 CR 2017 00060 Denmark ⤷  Subscribe PRODUCT NAME: RIBOCICLIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

KISQALI FEMARA CO-PACK (COPACKAGED) Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the KISQALI FEMARA CO-PACK

Introduction

The KISQALI FEMARA CO-PACK, a innovative combination of ribociclib (Kisqali) and letrozole (Femara), has marked a significant milestone in the treatment of hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in postmenopausal women. Here, we delve into the market dynamics and financial trajectory of this groundbreaking co-packaged therapy.

Regulatory Approval and Market Entry

The FDA approval of the KISQALI FEMARA CO-PACK in May 2017 was a pivotal moment, making it the first and only combination pack of two prescription products for advanced breast cancer[1][2][5].

Market Need and Target Population

The co-pack addresses a critical need in the treatment of HR+/HER2- advanced or metastatic breast cancer, a common subtype of breast cancer. This combination therapy is specifically designed for postmenopausal women, a demographic that often faces significant challenges in managing this condition.

Convenience and Cost Efficiency

One of the key market drivers for the KISQALI FEMARA CO-PACK is its convenience and cost efficiency. Patients can obtain a full 28-day cycle of both medications in one package with a single prescription and a single co-pay, which is the same cost as Kisqali alone[1][2][3].

Dosage and Administration

The co-pack is designed to simplify the treatment regimen. Kisqali is taken at a dose of 600 mg (three 200 mg tablets) once daily for 21 consecutive days, followed by 7 days off, while Femara is taken continuously at 2.5 mg once daily throughout the 28-day cycle[4][5].

Financial Impact on Patients

The co-packaging reduces the financial burden on patients by eliminating the need for separate prescriptions and co-pays for each medication. This is particularly beneficial for patients who may face high out-of-pocket costs for their treatments[1][3].

Market Competition

In the market for breast cancer treatments, the KISQALI FEMARA CO-PACK stands out due to its unique combination and convenience. However, it competes with other endocrine therapies and targeted treatments. The co-pack's advantage lies in its streamlined administration and cost-effectiveness, which can influence prescribing decisions by healthcare providers[2].

Revenue Potential

The approval and subsequent market entry of the KISQALI FEMARA CO-PACK have significant revenue implications for Novartis. Given the high prevalence of HR+/HER2- breast cancer and the preference for convenient, cost-effective treatments, the co-pack is poised to generate substantial revenue. The fact that the cost remains the same as Kisqali alone further enhances its market appeal and potential for increased sales[1][3].

Financial Assistance and Savings Programs

To further support patients, Novartis offers financial assistance and savings programs for Kisqali and the co-pack. These programs help mitigate the financial burden, making the treatment more accessible to a broader patient population[3].

Clinical Trials and Efficacy

The efficacy of the KISQALI FEMARA CO-PACK is backed by clinical trials such as MONALEESA-2 and MONALEESA-7, which demonstrated improved progression-free survival in patients with HR+/HER2- advanced breast cancer. These positive outcomes have bolstered the market confidence in this combination therapy[5].

Safety and Adverse Reactions

While the co-pack offers significant benefits, it also comes with potential side effects such as severe cutaneous adverse reactions, QT interval prolongation, hepatobiliary toxicity, and neutropenia. Monitoring and dose adjustments are crucial to manage these risks, which can impact patient compliance and overall market dynamics[5].

Future Outlook and Expansion

The success of the KISQALI FEMARA CO-PACK could pave the way for similar combination therapies in other cancer types. Novartis's commitment to innovative treatment solutions suggests a continued focus on developing and marketing such therapies, potentially expanding their market share and revenue streams.

Key Takeaways

  • Convenience and Cost Efficiency: The co-pack offers a single prescription and co-pay, simplifying treatment and reducing costs.
  • Market Need: Addresses a significant need in HR+/HER2- advanced or metastatic breast cancer treatment.
  • Revenue Potential: Poised to generate substantial revenue due to its unique combination and market appeal.
  • Financial Assistance: Supported by financial assistance and savings programs to enhance accessibility.
  • Clinical Efficacy: Backed by positive clinical trial outcomes.
  • Safety Monitoring: Requires careful monitoring and dose adjustments to manage potential side effects.

FAQs

  1. What is the KISQALI FEMARA CO-PACK used for?

    • The KISQALI FEMARA CO-PACK is used as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer[1][5].
  2. How is the KISQALI FEMARA CO-PACK administered?

    • The co-pack is administered orally with or without food. Kisqali is taken at 600 mg once daily for 21 days followed by 7 days off, while Femara is taken continuously at 2.5 mg once daily throughout the 28-day cycle[4][5].
  3. What are the potential side effects of the KISQALI FEMARA CO-PACK?

    • Potential side effects include severe cutaneous adverse reactions, QT interval prolongation, hepatobiliary toxicity, and neutropenia. Regular monitoring and dose adjustments are necessary to manage these risks[5].
  4. Is the KISQALI FEMARA CO-PACK more expensive than taking Kisqali and Femara separately?

    • No, the co-pack is available at the same cost as Kisqali alone, with the added benefit of a single prescription and co-pay[1][2][3].
  5. Are there any financial assistance programs available for the KISQALI FEMARA CO-PACK?

    • Yes, Novartis offers financial assistance and savings programs to help patients afford the treatment[3].

Cited Sources:

  1. Novartis. "Novartis receives FDA approval for first-of-its-kind Kisqali® Femara® Co-Pack for initial treatment of HR+/HER2- advanced or metastatic breast cancer." May 8, 2017.
  2. OncLive. "FDA Approves Co-Packaging of Ribociclib With Letrozole for Metastatic Breast Cancer." May 9, 2017.
  3. Medical News Today. "Kisqali and cost: Financial assistance options, savings, more."
  4. FDA. "KISQALI FEMARA CO-PACK (ribociclib tablets; letrozole tablets)." 2021.
  5. FDA. "KISQALI FEMARA CO-PACK - accessdata.fda.gov." 2023.

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