KISQALI FEMARA CO-PACK (COPACKAGED) Drug Patent Profile

When do Kisqali Femara Co-pack (copackaged) patents expire, 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-seven 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

Summary for KISQALI FEMARA CO-PACK (COPACKAGED)

International Patents:	187
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for KISQALI FEMARA CO-PACK (COPACKAGED)
DailyMed Link:	KISQALI FEMARA CO-PACK (COPACKAGED) at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for KISQALI FEMARA CO-PACK (COPACKAGED)

NDA:

209935

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 one FDA Regulatory Exclusivity.

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
Novartis	KISQALI FEMARA CO-PACK (COPACKAGED)	letrozole; ribociclib succinate	TABLET;ORAL	209935-001	May 4, 2017		RX	Yes	Yes			Y	Y
Novartis	KISQALI FEMARA CO-PACK (COPACKAGED)	letrozole; ribociclib succinate	TABLET;ORAL	209935-001	May 4, 2017		RX	Yes	Yes
Novartis	KISQALI FEMARA CO-PACK (COPACKAGED)	letrozole; ribociclib succinate	TABLET;ORAL	209935-001	May 4, 2017		RX	Yes	Yes			Y	Y
Novartis	KISQALI FEMARA CO-PACK (COPACKAGED)	letrozole; ribociclib succinate	TABLET;ORAL	209935-001	May 4, 2017		RX	Yes	Yes
Novartis	KISQALI FEMARA CO-PACK (COPACKAGED)	letrozole; ribociclib succinate	TABLET;ORAL	209935-001	May 4, 2017		RX	Yes	Yes

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

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 FEMARA CO-PACK (COPACKAGED) around the world.

Country	Patent Number	Title	Estimated Expiration
Cuba	24062	COMPUESTOS DE PIRROLOPIRIMIDINA COMO INHIBIDORES CDK
Ecuador	SP17075052	Tableta de Ribociclib
Japan	5882371
Portugal	3283058
Taiwan	I398252
Ukraine	103628	ПІРОЛОПІРИМІДИНИ ТА ЇХ ЗАСТОСУВАННЯ[ПИРРОЛОПИРИМИДИНЫ И ИХ ПРИМЕНЕНИЕ (PYRROLOPYRIMIDINE COMPOUNDS AND USE THEREOF)

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

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2331547	2017/060	Ireland		PRODUCT NAME: RIBOCICLIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/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
0236940	97C0053	Belgium		PRODUCT NAME: LETROZOLE; NAT. REGISTRATION NO/DATE: 206 IS 241 F 3 19970616; FIRST REGISTRATION: FR 341 474.2 1996072
2331547	C20170039 00245	Estonia		PRODUCT NAME: RIBOTSIKLIIB;REG NO/DATE: EU/1/17/1221 24.08.2017
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	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

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.