1197953‑54‑0, Brigatinib: The Latest News | ANQING CHICO PHARMACEUTICAL CO., LTD.

Abstract

Brigatinib (CAS 1197953‑54‑0) is a potent, next-generation ALK inhibitor originally developed by ARIAD Pharmaceuticals and later acquired by Takeda. Approved in the U.S. in April 2017 for ALK-positive, metastatic non-small cell lung cancer (NSCLC), and expanded to first-line use in May 2020, brigatinib offers improved efficacy, especially in brain metastases. With global sales estimated at $183 million in 2023 and projected around $237 million in 2024, brigatinib faces increasing competition from newer ALK inhibitors and emerging generics. Ongoing trials and new indications continue to drive its clinical utility and market presence.

Keywords

Brigatinib; ALK inhibitor; NSCLC; global sales; market competition; generics; regulatory approval

1. Introduction

Non-small cell lung cancer (NSCLC) driven by ALK rearrangements accounts for ~3–5% of lung cancers. Brigatinib targets ALK with high potency, including brain metastases, and improved safety over earlier inhibitors. This review covers its chemical properties, development, approvals, market performance, and future prospects.

2. Chemical & Physicochemical Properties

• CAS: 1197953‑54‑0

• Formula: C₂₉H₃₉ClN₇O₂P

• Molecular Weight: 584.09

• Appearance: White to off-white solid

• Melting Point: >203 °C (decomposition)

• Boiling Point: ~781.8 °C (predicted)

• Density: ~1.31 g/cm³ (predicted)

• Solubility: 1 mg/mL in heated DMSO

• pKa: 8.14 ± 0.42 (predicted)

3. Research & Development

Initially developed by ARIAD Pharmaceuticals, Brigatinib (Alunbrig®) was acquired by Takeda in 2017. It emerged from the ALTA and ALTA-1L pivotal trials, demonstrating superior progression-free survival (PFS) versus crizotinib, especially in patients with brain metastases.

4. Regulatory Approval Timeline

• U.S. (FDA):

  • April 28, 2017: Approved for ALK-positive metastatic NSCLC after crizotinib failure.

  • May 22, 2020: Expanded to first-line treatment based on ALTA-1L results.

• Approvals in other regions (EU, Japan, China, etc.) followed between 2018–2021 (not detailed here).

5. Global Sales & Market Performance

• 2023:

  • Global tablet sales: US$182.9 million.

  • Chinese market saw ~120 million ¥ (≈US$17 M) contribution to API market, with total API ~$85 M .

• 2024 (Projection):

  • Global tablet market estimated at US$237 million.

  • API and generic formulation volumes expected to grow similarly.

Estimated Annual Sales:

Note: 2020–22 values derived by backcasting from 2023 baseline and typical growth trajectory consistent with CAGR ~6–7% (accessdata.fda.gov).

6. Market Competition & Generics

• Competitors: Ceritinib, alectinib, lorlatinib continue to compete; each is positioned based on efficacy, side-effect profile, and CNS penetration. Brigatinib remains differentiated by brain metastases data.

• Generics: API market (~US$85 M) supports emerging generic formulations, especially in China and developing countries, though branded protection remains strong in major markets.

7. Ongoing Research & Indications

While primarily focused on ALK-positive NSCLC, brigatinib is also undergoing clinical evaluation in combination regimens and for other molecular contexts, aiming to strengthen its therapeutic portfolio.

8. Outlook

• Sales growth projection:

  • Expected CAGR ~6–7%, with revenues rising from US$183 M in 2023 to US$237 M in 2024.

  • API and generic markets further expand geographic access and production volume.

• Market trends:

  • Efficacy in brain metastases keeps brigatinib competitive.

  • Emerging generics may pressure margins, especially outside the U.S./EU.

  • Future label expansions and regional approvals will influence uptake.

References

1. FDA approvals (2017 initial, 2020 frontline expansion)

2. Global tablet sales 2023, estimate 2024

3. API market figures (~US$85 M)

4. Competitive landscape & ongoing research

Active Pharmaceutical Ingredient

1197953-54-0,Brigatinib,(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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