Ribociclib succinate - Generic Drug Details

What are the generic sources for ribociclib succinate and what is the scope of freedom to operate?

Ribociclib succinate is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ribociclib succinate has one hundred and eighty-four patent family members in fifty-three countries.

One supplier is listed for this compound.

Summary for ribociclib succinate

International Patents:	184
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	51
Patent Applications:	89
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ribociclib succinate
DailyMed Link:	ribociclib succinate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ribociclib succinate

Constraining patent/regulatory exclusivity:

10,799,506

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.

Pharmacology for ribociclib succinate

Drug Class	Kinase Inhibitor
Mechanism of Action	Cytochrome P450 3A Inhibitors Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ribociclib succinate

L01EF	Cyclin-dependent kinase (CDK) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for RIBOCICLIB SUCCINATE

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 ribociclib succinate

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	9,416,136
Novartis	KISQALI	ribociclib succinate	TABLET;ORAL	209092-001	Mar 13, 2017		RX	Yes	Yes	9,193,732		Y	Y
Novartis	KISQALI	ribociclib succinate	TABLET;ORAL	209092-001	Mar 13, 2017		RX	Yes	Yes

International Patents for ribociclib succinate

Country	Patent Number	Title	Estimated Expiration
Spain	2623133
Australia	2022215155	Ribociclib tablet
South Korea	101353857

Supplementary Protection Certificates for ribociclib succinate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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

Ribociclib succinate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ribociclib Succinate

Market Overview

Ribociclib succinate, marketed as Kisqali, is a targeted therapy that has revolutionized the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer. The market for ribociclib succinate is characterized by rapid expansion, driven by several key factors.

Market Drivers

Rising Incidence of Breast Cancer

The increasing global incidence of breast cancer, particularly in postmenopausal women, is a primary driver of the ribociclib succinate market. Factors such as aging populations, lifestyle changes, and genetic predispositions contribute to the growing burden of breast cancer, driving the demand for effective treatment options like ribociclib succinate[1][3].

Advancements in Cancer Treatment

The development of targeted therapies like ribociclib succinate represents a significant advancement in cancer treatment. Unlike traditional chemotherapy, these therapies specifically target cancer cells while minimizing damage to healthy tissues, leading to improved treatment outcomes and quality of life for patients[1].

Regulatory Approvals and Combination Therapies

Regulatory approvals for new indications and combination therapies have significantly boosted the market growth of ribociclib succinate. For example, the FDA approval for co-packaging ribociclib with letrozole (Femara) has streamlined treatment regimens and improved patient compliance[2].

Patient Advocacy and Awareness

Increased patient awareness and advocacy for breast cancer screening and treatment have also driven the demand for ribociclib succinate. Patients are more informed about the benefits of targeted therapies, which has led to higher adoption rates[3].

Competitive Landscape

CDK 4/6 Inhibitors

The market for ribociclib succinate is part of a broader landscape that includes other CDK 4/6 inhibitors such as palbociclib and abemaciclib. While these competitors pose a challenge, ribociclib succinate's proven efficacy and favorable safety profile have helped it maintain a strong market position[3].

Market Segmentation

The global ribociclib succinate market is segmented based on indication, distribution channel, treatment line, and geography. The primary indication is advanced breast cancer, particularly in HR-positive, HER2-negative cases. Distribution channels include hospital pharmacies and specialty cancer centers, with some formulations available through retail pharmacies[3][4].

Financial Trajectory

Market Size and Growth

The global ribociclib succinate market is valued at USD 6.2 billion in 2023 and is projected to reach USD 12.5 billion by 2030, growing at a CAGR of 10.16% during the forecast period 2024-2030. This robust growth is driven by increasing adoption, regulatory approvals, and expanding indications[3].

Revenue Projections

The market is expected to experience sustained growth due to ongoing advancements in cancer treatment, increasing adoption of targeted therapies, and rising awareness of breast cancer screening and early detection. Market players who innovate, collaborate, and prioritize patient-centric care are well-positioned to capitalize on these opportunities[1][4].

Regional Analysis

North America and Europe

North America and Europe lead the market, driven by well-established healthcare systems, high diagnosis rates of breast cancer, and early access to innovative therapies. These regions have seen significant adoption of ribociclib succinate due to favorable regulatory environments and strong healthcare infrastructure[1].

Emerging Markets

Emerging economies in Asia-Pacific and Latin America offer growth opportunities due to improving healthcare access and rising awareness of breast cancer screening and treatment. These regions are expected to contribute significantly to the market's future growth[1].

Challenges and Restraints

High Treatment Costs

One of the significant challenges facing the ribociclib succinate market is the high treatment cost. This can make the treatment less accessible, especially in areas with limited health insurance coverage or where patients must pay a substantial portion of the costs out-of-pocket[3].

Adverse Effects and Tolerability Issues

Ribociclib succinate can cause adverse effects such as grade 3/4 neutropenia and leukopenia, which require close monitoring and management. These side effects can impact patient compliance and overall treatment outcomes[2].

Competition and Patent Expiry

The market also faces competition from other CDK 4/6 inhibitors and the impending expiry of ribociclib succinate's patents, which could lead to generic competition and reduce the market share of the brand-name drug[3].

Patient Support and Financial Assistance

Novartis Patient Support

To address the high treatment costs, Novartis offers patient support programs, including financial assistance options. Patients with private insurance may be eligible to pay as little as $0 for ribociclib succinate through the Co-Pay Plus offer, which has an annual benefit limit of $15,000[5].

Key Trends and Future Outlook

Novel Combination Therapies

The market is witnessing a trend towards the development of novel combination therapies and biomarker-driven treatment approaches. Efforts to overcome resistance mechanisms and improve patient outcomes are also driving innovation in this space[1].

Patient-Centric Care and Precision Medicine

There is an increasing focus on patient-centric care, precision medicine, and value-based healthcare models to optimize treatment outcomes and resource utilization. These trends are expected to continue shaping the market in the future[1].

Covid-19 Impact

The Covid-19 pandemic has had a mixed impact on the ribociclib succinate market. While it disrupted healthcare systems and delayed cancer screenings and diagnoses, the long-term impact is expected to be positive as healthcare systems adapt to the new normal and prioritize cancer care[1].

Key Industry Developments

Regulatory Approvals and Clinical Trials

Key industry developments include regulatory approvals for new indications, advancements in combination therapies, and ongoing clinical trials exploring novel treatment strategies. Pharmaceutical companies continue to invest in research and development to enhance the therapeutic potential of ribociclib succinate and address unmet medical needs in cancer care[1].

"Providing physicians a convenient 1-package prescribing option for their patients underscores our commitment to deliver innovative treatment solutions to the metastatic breast cancer community" - Bill Hinshaw, Executive Vice President and US Head of Novartis Oncology[2].

Key Takeaways

• The ribociclib succinate market is driven by the rising incidence of breast cancer, advancements in cancer treatment, and regulatory approvals.
• The market is expected to grow significantly, reaching USD 12.5 billion by 2030.
• High treatment costs and competition from other CDK 4/6 inhibitors are key challenges.
• Patient support programs and financial assistance options are available to make the treatment more accessible.
• The market is trending towards novel combination therapies, patient-centric care, and precision medicine.

Frequently Asked Questions

1. What is ribociclib succinate used for?

Ribociclib succinate is used for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer, particularly in postmenopausal women.

2. What are the key drivers of the ribociclib succinate market?

The key drivers include the rising incidence of breast cancer, advancements in cancer treatment protocols, and regulatory approvals for new indications and combination therapies.

3. How does ribociclib succinate compare to other CDK 4/6 inhibitors?

Ribociclib succinate has a proven efficacy and favorable safety profile, but it faces competition from other CDK 4/6 inhibitors like palbociclib and abemaciclib.

4. What are the main challenges facing the ribociclib succinate market?

High treatment costs, adverse effects, and competition from other CDK 4/6 inhibitors are significant challenges. Additionally, the impending expiry of patents could lead to generic competition.

5. Are there any financial assistance programs available for patients taking ribociclib succinate?

Yes, Novartis offers patient support programs, including financial assistance options, to make the treatment more accessible. Patients with private insurance may be eligible to pay as little as $0 for ribociclib succinate through the Co-Pay Plus offer.

Cited Sources:

1. MarkWide Research: Ribociclib Succinate Market 2024-2032 | Size, Share, Growth.
2. OncLive: FDA Approves Co-Packaging of Ribociclib With Letrozole for Metastatic Breast Cancer.
3. Verified Market Research: Ribociclib Market Size, Trends, Share, Growth & Forecast.
4. Market Research Intellect: Ribociclib Succinate Market Size, Scope And Forecast Report.
5. Novartis: Novartis Patient Support - KISQALI® (ribociclib).