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283173?50?2,?Rucaparib: The Latest News | ANQING CHICO PHARMACEUTICAL CO., LTD.

Abstract

Rucaparib (Rubraca®) is an oral PARP?1/2 inhibitor, initially developed through Newcastle University/Agouron by Clovis Oncology, and now commercialized by Pharma&. First approved in December 2016 by the FDA for BRCA?mutated advanced ovarian cancer, its label expanded in April 2018 to maintenance therapy, and in May 2020 to include BRCA?mutated metastatic castration?resistant prostate cancer (mCRPC). It recently gained first-line ovarian cancer maintenance approval in the EU/UK in late 2023/early 2024. Global sales grew from an estimated USD?350?million in 2020 to USD?550?million in 2023, with projected 2024 revenues around USD?620?million. As part of the expanding PARP inhibitor market, rucaparib faces competition from olaparib, niraparib, talazoparib, and growing generic API demand. Ongoing pipeline expansion and label extensions underpin future growth.

Keywords

Rucaparib; Rubraca; PARP inhibitor; ovarian cancer; prostate cancer; global sales; market competition; generics; Pharma&; ATHENA?MONO

1. Introduction

Rucaparib inhibits PARP enzymes involved in cancer cell DNA repair, particularly effective in BRCA?mutated and platinum?sensitive ovarian cancers, as well as mCRPC with BRCA alterations?

2. Chemical & Physicochemical Properties

• CAS: 283173?50?2

• Formula: C??H??FN?O

• Molecular Weight: 323.36

• Appearance: Yellow solid

• Melting Point: 187–189?°C; Boiling Point: ~625?°C

• Density: ~1.281?g/cm³

• Solubility: Slight in DMSO/methanol; pKa ~14.1?

3. Research & Development

Rucaparib originated from Newcastle University/Agouron and was developed by Clovis Oncology. Clovis later divested it to Pharma& amid bankruptcy in 2023?. Key phase III trials include ARIEL3/4 and ATHENA-MONO supporting first-line label expansion.

4. Regulatory Approval Timeline

• Dec 19, 2016 (FDA): Accelerated approval for BRCA?mutated advanced ovarian cancer?.

• Apr 6, 2018 (FDA): Approved for maintenance therapy in recurrent platinum-sensitive ovarian cancer?.

• May 15, 2020 (FDA): Accelerated approval for BRCA-mutated mCRPC.

• Nov 20, 2023 (EC) & Jan 2024 (UK MHRA): First-line maintenance in advanced ovarian cancer regardless of BRCA status (ATHENA-MONO)?.

5. Global Sales & Market Performance

Estimated Annual Rucaparib Sales (USD Millions)

• Strong uptake post-label expansion; 2023 global annual sales reached approximately USD?550?M.

• 2024 projected growth (~12%) due to first-line approval in major markets?(verifiedmarketreports.com).

6. Global API & Generics Market

• The global Finished API market is expanding; North America and Europe lead in demand.

• China/APAC markets show fast growth; API forecasted to reach ~USD?350?M by 2033.

7. Competition & Generics

• Competing PARP inhibitors: olaparib, niraparib, talazoparib.

• Rucaparib offers broad indication across ovarian and prostate cancers.

• Patent expiry around 2028–2029 may trigger generic competition for API/tablets.

8. Other News & Pipeline

• ATHENA-MONO trial triggered EU/UK first-line approvals?.

• Clovis Oncology’s bankruptcy led to the licensing out of Rubraca to Pharma&?.

• Combination with new agents, expansion into non-oncology DNA repair vulnerabilities anticipated.

9. Outlook

• PARP inhibitor market forecast to reach ~USD?6.3?B in 2024 with 8.7% CAGR to 2034.

• Rucaparib poised for continued growth with expanded labels.

• Generic competition post-patent expiry may affect pricing, especially in generics-ready markets.

References

• Chemical properties & mechanism (de.wikipedia.org)

• FDA approvals & trial data

• Sales & API market data (fda.gov)

• Regulatory expansion news

• Commercial transition news

Active Pharmaceutical Ingredient

283173-50-2,Rucaparib,(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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