763113‑22‑0, Olaparib: The Latest News | ANQING CHICO PHARMACEUTICAL CO., LTD.

Abstract

Olaparib (CAS 763113‑22‑0), marketed as Lynparza, is a pioneering PARP inhibitor originally discovered by KuDOS and later developed by AstraZeneca in collaboration with Merck. Since its first approval in the US and EU in December 2014 for germline BRCA-mutated ovarian cancer, approvals have expanded to multiple cancer types including breast, prostate, pancreatic, and endometrial cancers. Global revenues have grown from estimated $2.0 billion in 2020 to about $2.3 billion in 2023, with full-year 2024 sales projected around $2.6 billion. Olaparib remains the dominant PARP inhibitor (86% market share in 2024), but upcoming generics and newer PARP agents present competitive challenges. Continued label expansions and strong API demand position it for sustained growth.

Keywords: Olaparib, Lynparza, PARP inhibitor, BRCA, global sales, generics, drug development

1. Introduction

Olaparib selectively inhibits PARP-1/2/3, disrupting DNA repair pathways essential in BRCA-mutated cancers. It marked the first approval in its class (PARP inhibitor) and revolutionized targeted therapy in oncology.

2. Chemical & Physicochemical Properties

• CAS: 763113‑22‑0

• Formula: C₂₄H₂₃FN₄O₃

• Molecular Weight: 434.46

• Appearance: White solid

• Density: ~1.43 g/cm³

• Solubility: DMSO: 33 mg/mL; Ethanol: 1.7 mg/mL

• pKa: ~12.07

• Storage: −20 °C (en.wikipedia.org, zh.wikipedia.org)

3. Research & Development

Developed by KuDOS Pharmaceuticals (UK), acquired by AstraZeneca in 2006. Co-developed with Merck from 2017 with multiple indication expansions across cancer types . Key trials demonstrated significant progression-free survival benefits in ovarian, breast, prostate, and pancreatic cancers .

4. Regulatory Timeline

• December 2014: FDA & EMA approvals for gBRCA-mutated ovarian cancer.

• 2017–2020: Expanded approvals:

  • 2017: maintenance therapy in recurrent ovarian cancer

  • 2018: HER2-negative gBRCA breast cancer

  • 2021: prostate cancer in China (NMPA conditional approval) .

5. Market Performance & Speculative Sales

• In 2023, the global olaparib market reached approximately US$2.3 billion (dataintelo.com).

• As first-in-class, olaparib holds ~86.2% market share in the PARP inhibitor sector in 2024 (futuremarketinsights.com).

• The API market for olaparib stood at ~US$928 M in 2023, with projected growth to ~US$2.5 B by 2030 (reports.valuates.com).

6. Market Competition & Generics

• Olaparib remains the leading PARP inhibitor, though rucaparib, niraparib, talazoparib, and upcoming agents vie for market share .

• US patent protection extends through 2028; generic erosion expected thereafter .

• API demand drives production by companies such as Reddy’s, Sun Pharma, and ScinoPharm, especially in APAC regions .

7. Ongoing Research & Related News

• Label expansions continue in endometrial and pancreatic cancers .

• AstraZeneca and Merck-O announced strategic collaboration in 2017 to enhance combination strategies.

• Reports indicate imminent readouts from Clovis and Pfizer in prostate cancer that may challenge olaparib’s dominance.

8. Outlook & Forecast

• The olaparib market is projected to reach US$4.8 B in 2024, continuing to grow to ~US$7.2 B by 2031 .

• Sustained growth driven by first-in-class advantage, strong pipeline, and APAC demand.

• Patents expiring in 2028 could trigger price competition from generics, although AstraZeneca’s global reach and branding are likely to support continued uptake.

References

1. Chemical properties, CAS, solubility, approved indications

2. Regulatory history & indications

3. Market data (2023–2024) and market share

4. API market data (onclive.com)

5. Competition and future generics

6. Strategic partnerships and ongoing trials

Active Pharmaceutical Ingredient

763113-22-0,Olaparib,(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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