1374639‑75‑4, Ribociclib Succinate: The Latest News | ANQING CHICO PHARMACEUTICAL CO., LTD.

Abstract

Ribociclib (brand name: Kisqali®, succinate salt LEE‑011) is an oral selective CDK4/6 inhibitor developed by Novartis (in partnership with Astex). Approved by the FDA in March 2017 for HR⁺/HER2⁻ advanced breast cancer, it has since received multiple label expansions, including adjuvant indication in early high-risk breast cancer in 2024. Global sales reached approximately US$1.5 billion in 2024, doubling from US$0.8 billion in 2020, with estimates at US$1.0 billion (2021), US$1.2 billion (2022), and US$1.3 billion (2023). As a cornerstone CDK4/6 therapy, ribociclib competes closely with palbociclib and abemaciclib. Patent protection extends into the late 2020s, with generic entry expected thereafter. The API market was valued at US$1.9 billion in 2024. Ongoing phase III trials in earlier breast cancer settings and potential applications in other tumor types will shape its future trajectory.

Keywords

Ribociclib; Kisqali; CDK4/6 inhibitor; breast cancer; global sales; market competition; API; Novartis; patent expiry

1. Introduction

Ribociclib is a potent cyclin-dependent kinase (CDK) 4/6 inhibitor that halts breast cancer cell proliferation. Its key benefits include improved progression-free survival (PFS) and overall survival (OS) when combined with endocrine therapy, demonstrated in the MONALEESA clinical trials .

2. Chemical & Physicochemical Properties

• CAS Number: 1374639‑75‑4

• Synonym: LEE‑011 (ribociclib succinate)

• Formula: C₂₇H₃₆N₈O₅ · H₂SO₄

• Molecular Weight: 552.64

• Appearance: Light beige solid

• Melting Point: >160 °C (decomposition)

• Solubility: Slightly soluble in DMSO and methanol 

• Storage: Refrigerate (2–8 °C)

3. Research & Development

Developed through collaboration between Novartis and Astex Pharmaceuticals, ribociclib underwent pivotal clinical evaluation in the MONALEESA program (MONALEESA-2, 3, and 7), which demonstrated significant OS benefit across varied combinations.

4. Approval Timeline

• March 13, 2017 (FDA): Approved for HR⁺/HER2⁻ advanced/metastatic breast cancer in combination with letrozole .

• August 2017 (EMA): Approved in the EU .

• February 2021 (UK NHS & MHRA): Approved in the UK for pre/perimenopausal women .

• September 17, 2024 (FDA): Expanded for adjuvant use in early-stage high-risk HR⁺/HER2⁻ breast cancer (with letrozole) .

• November 2024 (EC): EU counterpart approval for adjuvant setting .

5. Market Performance & Sales Trends

Estimated Global Sales (USD billions)

• The 2024 market was valued at US$1.5 B, with expected doubling to US$3.5 B by 2033 (verifiedmarketreports.com).

• In 2023, the total CDK4/6 inhibitor market reached US$6.2 B, with ribociclib claiming approximately 24% share (verifiedmarketresearch.com).

• North America leads (~45%), followed by Europe (~30%). Asia–Pacific shows rapid growth (verifiedmarketreports.com).

6. API & Generic Market

• API Market Size (2024): US$1.907 B, with ~264 million tablets produced .

• Growth expected to US$2.806 B by 2033 (~1.6% CAGR) .

• Patent protection likely holds through 2028–2029, delaying generic launch.

7. Competitive Landscape

• Primary competitors: Palbociclib (Ibrance) and Abemaciclib (Verzenio).

• Ribociclib distinguishes itself by consistent OS data and expanded adjuvant use .

• Clinical trials are exploring combinations with PI3K, AKT, and immune-modulatory agents for further differentiation.

8. Recent Developments & Outlook

• Landmark approvals in adjuvant high-risk early breast cancer (FDA & EMA, late 2024) support broadened adoption .

• Market forecasts: Global market estimated at US$1.5 B (2024) and projected at US$3.5 B by 2033 (9.5% CAGR) .

• Future growth drivers: Trial expansion into other solid tumors; continued geographic penetration.

9. Conclusions

Ribociclib has become a mainstay in HR⁺/HER2⁻ breast cancer therapy, with rapid growth from ~US$800 M in 2020 to US$1.5 B in 2024. Ongoing clinical data and expanded indications support a bullish forecast nearing US$3.5 B by 2033. Patent expiry remains a future risk, but current R&D and brand strength position ribociclib favorably in the oncology landscape.

References

1. Chemical, regulatory, clinical details (en.wikipedia.org)

2. Sales and forecast data (verifiedmarketreports.com)

3. API market stats (precisionbusinessinsights.com)

4. Geographic and market share analysis 

Active Pharmaceutical Ingredient

1374639-75-4,Ribociclib Succinate,(chemical grade, purity ≥99.0%) are currently supplied by our company. [Own compliance factory, fully support factory audit] For details, you can call the bottom line to get the latest price of the product!

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