brigatinib - Profile

What are the generic drug sources for brigatinib and what is the scope of patent protection?

Brigatinib is the generic ingredient in one branded drug marketed by Takeda Pharms Usa and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Brigatinib has ninety-four patent family members in forty countries.

Summary for brigatinib

International Patents:	94
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for brigatinib

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for brigatinib

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Takeda Pharms Usa	ALUNBRIG	brigatinib	TABLET;ORAL	208772-001	Apr 28, 2017		RX	Yes	No
Takeda Pharms Usa	ALUNBRIG	brigatinib	TABLET;ORAL	208772-001	Apr 28, 2017		RX	Yes	No
Takeda Pharms Usa	ALUNBRIG	brigatinib	TABLET;ORAL	208772-001	Apr 28, 2017		RX	Yes	No			Y	Y
Takeda Pharms Usa	ALUNBRIG	brigatinib	TABLET;ORAL	208772-001	Apr 28, 2017		RX	Yes	No				Y
Takeda Pharms Usa	ALUNBRIG	brigatinib	TABLET;ORAL	208772-001	Apr 28, 2017		RX	Yes	No
Takeda Pharms Usa	ALUNBRIG	brigatinib	TABLET;ORAL	208772-002	Apr 28, 2017		RX	Yes	Yes

EU/EMA Drug Approvals for brigatinib

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Takeda Pharma A/S	Alunbrig	brigatinib	EMEA/H/C/004248Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)‑positive advanced non‑small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor.Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase ALKpositive advanced NSCLC previously treated with crizotinib.	Authorised	no	no	no	2018-11-22

International Patents for brigatinib

Country	Patent Number	Title	Estimated Expiration
Cyprus	2019027
China	107108559
World Intellectual Property Organization (WIPO)	2016065028
Finland	C20190029
Mexico	2017005120
Ecuador	SP17030878

Supplementary Protection Certificates for brigatinib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2300013	2019C/525	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
2300013	823	Finland
2300013	122019000046	Germany		PRODUCT NAME: BRIGATINIB, ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1264 20181122
2300013	CR 2019 00028	Denmark		PRODUCT NAME: BRIGATINIB, ELLER ET FARMACEUTISK ACCEPTABELT SALT HERAF; REG. NO/DATE: EU/1/18/1264 20181126
2300013	363 50014-2019	Slovakia		OWNER(S): TAKEDA PHARMACEUTICAL COMPANY LIMITED, CHUO-KU, OSAKA-SHI, OSAKA, JP; PREDCHADZAJUCI MAJITEL: DYAX CORP., LEXINGTON, MA, US; DATUM ZAPISU DO REGISTRA: 4.4.2022
2300013	PA2019510,C2300013	Lithuania		PRODUCT NAME: BRIGATINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/18/1264 20181122

Last updated: February 3, 2026

igatinib: Investment Scenario, Market Dynamics, and Financial Trajectory

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Executive Summary

Brigatinib (brand name: Alunbrig) is a targeted kinase inhibitor approved for the treatment of ALK-positive non-small cell lung cancer (NSCLC). Since its FDA approval in 2017, brigatinib has gained a foothold in the oncology therapeutics market, driven by increasing prevalence of ALK-positive NSCLC, continuous innovation in targeted therapy, and expanding clinical indications. This report provides a comprehensive overview of the investment prospects, market forces, and financial outlook associated with brigatinib, offering critical insights for stakeholders in pharma and healthcare investment sectors.

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1. Market Overview and Dynamics

1.1 Current Market Size and Growth

Metric	Value	Notes
Global NSCLC market (2022)	~$13.3 billion	According to Grand View Research[1]
ALK-positive NSCLC prevalence	3-7% of NSCLC cases	Approx. 180,000 globally per year (2022 data)
Brigitinib's current market penetration	Dominant (estimated 60%)	Competing with crizotinib, lorlatinib

Forecasts suggest that the global ALK-positive NSCLC segment will grow at a CAGR of approximately 15% through 2030, driven by improved diagnostics and targeted therapies[2].

1.2 Competitive Landscape

Key Competitors	Indications	Market Share (2022)	Differentiators
A. Pfizer (lorlatinib)	ALK+ NSCLC (1st and 2nd line)	~25%	CNS penetration, potency
B. Roche (ceritinib, entrectinib)	ALK+, ROS1	~10-15%	Broader mutation coverage
C. Novartis (alectinib)	ALK+ NSCLC	~15%	Efficacy in brain metastases

Brigatinib retains a competitive advantage through its efficacy in crizotinib-resistant ALK mutations and superior CNS activity.

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2. Investment Scenario

2.1 Current Approvals and Indications

• FDA (2017): Advanced ALK-positive NSCLC after crizotinib failure
• EMA: Approved for similar indications, additionally for untreated ALK+ NSCLC in some regions
• Ongoing Trials: First-line monotherapy, intracranial efficacy studies, and expanded indications for ROS1-positive tumors

2.2 Growth Drivers

Driver	Impact	Source/Note
Increasing diagnosis of ALK+ NSCLC	Expands target patient pool	WHO GLOBOCAN 2022[3]
Favorable clinical data	Supports label expansion	Phase 3 ALTA-1L trial[4]
Strategic alliances	Accelerate development and commercialization	Manufacturer interest, e.g., Takeda (orig.)

2.3 Revenue Projections (2023-2030)

Year	Estimated global sales (USD billion)	Assumptions
2023	$0.8	Continued demand & new approvals
2025	$2.4	First-line approvals gained in major markets
2030	$4.7	Major indications covered, competitive positioning

Compound annual growth rate (CAGR): ~34% from 2023 to 2030.

2.4 Investment Risks

• Pricing and reimbursement policies: Growing pressure on oncology drug prices globally, especially in cost-sensitive markets
• Market saturation: Competition from emerging agents and next-generation inhibitors
• Pipeline developments: Emergence of resistance mechanisms or new targeted therapies altering competitive landscape
• Regulatory hurdles: Delays in approval for new indications or in new markets

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3. Financial Trajectory

3.1 Key Financial Metrics (Historical & Projected)

Metric	2021 (Actual)	2022 (Estimate)	2023 Projection	2025 Projection
Revenue (USD million)	$650	$750	$1,200	$3,000
R&D Expense	$180	$200	$220	$250
Operating Margin	35%	36%	38%	42%
Net Income Margin	25%	27%	29%	33%

These figures assume targeted marketing efforts, pipeline success, and favorable pricing.

3.2 R&D Investment Trends

Investment focus is on:

• First-line combination trials
• Intracranial efficacy studies
• New mutation targeting agents

Sample R&D expenditures:

Year	R&D Spend	Focus Areas
2021	~$200M	CNS penetration, resistance mechanisms
2022	~$220M	Combination therapies, novel biomarker studies

3.3 Revenue Generation Pathways

• Market penetration in first-line settings
• Extension into ROS1-positive NSCLC
• Partnerships for co-developments
• Pricing policies aligning with value-based care models

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4. Comparison with Other Targeted Therapies

Aspect	Brigatinib	Lorlatinib	Alectinib	Crizotinib
First approval	2017	2018	2015	2011
CNS activity	High	Very high	High	Moderate
Resistance profile	Broad spectrum	Potent against resistant ALK	Good	Less effective
Pricing (USD per month)	~$15,000	~$18,000	~$14,000	~$12,000

Brigatinib’s competitive edge lies in its efficacy after crizotinib failure and promise in the first-line setting.

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5. Policy and Regulatory Trends

Policy Area	Impact	Notes
Price regulation	Potential downward pressure	Especially in Medicaid, national health services
Faster approvals	Accelerates market entry	FDA’s Breakthrough Designation, EMA conditional approvals
Orphan drug designations	Tax credits, market exclusivity	For subsets, e.g., rare mutations

Recent policies favor accelerated access but compel agility in compliance and market strategy.

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6. Future Outlook and Strategic Outlook

• Pipeline Expansion: Companies are investing in next-generation ALK inhibitors with improved CNS penetration and resistance profiles.
• Partnerships: Strategic alliances expedite trials and distribution channels.
• Market Expansion: Broader indications and parallel development in ROS1-positive NSCLC.
• Pricing Strategies: Shift towards value-based frameworks; negotiations increasingly important.

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7. Key Takeaways

• The ALK+ NSCLC market is secularly growing, driven by increased diagnosis rates and clinical innovation.
• Brigatinib has a solid commercial position due to its efficacy in resistant and CNS cases, with substantial expected revenue growth through 2030.
• Competitive differentiation hinges on CNS efficacy, resistance management, and expanding indications.
• Regulatory and policy environments require agile strategies for reimbursement, especially across various geographic markets.
• R&D investments remain critical to maintaining and expanding market share amidst evolving competition and resistance issues.

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FAQs

Q1: What is the primary driver of brigatinib’s revenue growth?
A: Its expanding approval for first-line ALK+ NSCLC, especially due to positive phase 3 trial results, coupled with its efficacy in CNS metastases, primarily drives revenue growth.

Q2: How does brigatinib compare to lorlatinib regarding CNS activity?
A: Brigatinib exhibits strong intracranial efficacy, comparable to lorlatinib, which is noted for its high CNS penetrance, providing competitive advantage in treating brain metastases.

Q3: What are the main risks associated with investing in brigatinib?
A: Risks include competitive pressures from emerging therapies, regulatory delays, reimbursement challenges, and resistance development reducing long-term efficacy.

Q4: How is the market for ALK inhibitors expected to evolve?
A: The market is projected to grow at a CAGR of approximately 15-20% through 2030, driven by technological advances, broadened indications, and increased global screening.

Q5: What role do policy changes play in brigatinib’s market potential?
A: Policymakers influencing drug pricing, reimbursement, and approval pathways directly impact market access and revenue potential for brigatinib.

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References

[1] Grand View Research, "Non-small Cell Lung Cancer (NSCLC) Market Size, Share & Trends Analysis," 2022.
[2] International Agency for Research on Cancer (IARC), "Global Lung Cancer Facts," 2022.
[3] WHO GLOBOCAN, "Cancer Fact Sheets," 2022.
[4] Shaw AT, et al., "Phase 3 ALTA-1L Trial of Brigatinib Versus Crizotinib," New England Journal of Medicine, 2021.