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1613220?15?7,?Niraparib Tosylate Monohydrate (MK?4827): The Latest News | ANQING CHICO PHARMACEUTICAL CO., LTD.

Abstract

Niraparib (Zejula®, MK?4827) is a once-daily oral PARP inhibitor first approved in March?2017 (US) and November?2017 (EU) for maintenance treatment in ovarian cancer. Developed by Tesaro (now part of GSK), it selectively inhibits PARP?1 and PARP?2, interfering with DNA repair. Approvals have expanded to first-line and platinum-sensitive maintenance settings. Global sales rose from approximately US$539?M in 2020 to an estimated US$720?M in 2023, with US$810?M projected for 2024. Niraparib maintains a solid share in the PARP market but now faces competition from other inhibitors and branded combination products like Akeega. Patent expiry around 2028 may trigger generic entry. Recent news includes strategic royalty rulings and expanded combinations.

Keywords

Niraparib; PARP inhibitor; ovarian cancer; global sales; market competition; Akeega; patent

1. Introduction

Niraparib inhibits PARP?1/2, inducing synthetic lethality in tumor cells, especially those with DNA repair deficiencies. It gained swift approval following strong NOVA Phase III results in recurrent ovarian cancer?.

2. Chemical & Physicochemical Properties

• CAS:?1613220?15?7

• Synonym: MK?4827 (niraparib tosylate monohydrate)

• Formula: C??H??N?O?S

• MRW: 492.59

• Appearance: White to off-white solid

• Solubility: High in DMSO; moderate in ethanol.

3. Research & Development

Originally discovered by Merck, licensed to Tesaro in 2012. Key clinical trials:

• NOVA (germline and non?germline BRCA recurrent ovarian cancer)

• PRIME and others expanding first-line maintenance?

4. Regulatory Approvals

• US FDA: March?27,?2017 – maintenance after platinum response

• EU EMA: November?16,?2017

• Expanded to first-line maintenance (Apr?2020) and HRD-positive settings, including mCRPC combo approval for Akeega (Aug?2023)

5. Market Performance

Annual Global Sales (Rough Estimates, USD million)

1 Based on GSK’s 2022 Q1 data: £339?M (~US$539?M) (dataintelo.com, finance.ifeng.com).
2 Growth tracking between 2020–2023 suggests approximately +13% CAGR. Additional forecast data supports ~US$810?M in 2024?.

In 2023, North America led (~45%), followed by Europe (25%) and Asia?Pacific (20%)?(verifiedmarketreports.com).

6. Competition & Generics

• Competing PARP inhibitors: olaparib, rucaparib, talazoparib.

• Market share supported by combination labels like Akeega (niraparib + abiraterone), EU/US approvals in Aug?2023?

• Patent protection expected until ~2028; generic entry after likely to pressure pricing?.

7. Other Related News

• Patent Rule: GSK required to pay royalties to AstraZeneca for Zejula sales based on a ruling?

• Market Growth: PARP inhibitor market valued at ~US$6.3?Bn in 2024, growing at ~8.7% CAGR; niraparib is a key player

8. Outlook & Forecast

• Overall PARP inhibitors expected to reach US$16?Bn by 2034?

• Niraparib sales continue robustly, but future forces include:

  • First-line indication expansion

  • Jan combination therapy uptake

  • Patent expiry and generics entry post-2028

References

• Regulatory and clinical data?

• Sales and market data (GSK reports, forecasts)?

• Market valuations and competition?

Active Pharmaceutical Ingredient

1613220-15-7,Niraparib Tosylate Monohydrate,(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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