BRIGATINIB - Generic Drug Details

What are the generic 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.

One supplier is listed for this compound.

Summary for BRIGATINIB

International Patents:	94
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	72
Clinical Trials:	35
Patent Applications:	5,311
What excipients (inactive ingredients) are in BRIGATINIB?	BRIGATINIB excipients list
DailyMed Link:	BRIGATINIB at DailyMed

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

Constraining patent/regulatory exclusivity:

10,385,078

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.

Recent Clinical Trials for BRIGATINIB

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Guangdong Association of Clinical Trials	PHASE3
University Health Network, Toronto	PHASE2
M.D. Anderson Cancer Center	PHASE2

See all BRIGATINIB clinical trials

Pharmacology for BRIGATINIB

Drug Class	Kinase Inhibitor
Mechanism of Action	Cytochrome P450 3A Inducers Tyrosine Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for BRIGATINIB

L01ED	Anaplastic lymphoma kinase (ALK) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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	208772-002	Apr 28, 2017		RX	Yes	No	10,385,078		Y	Y
Takeda Pharms Usa	ALUNBRIG	brigatinib	TABLET;ORAL	208772-002	Apr 28, 2017		RX	Yes	No	9,012,462			Y
Takeda Pharms Usa	ALUNBRIG	brigatinib	TABLET;ORAL	208772-002	Apr 28, 2017		RX	Yes	No	9,273,077
Takeda Pharms Usa	ALUNBRIG	brigatinib	TABLET;ORAL	208772-002	Apr 28, 2017		RX	Yes	No	9,611,283

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
China	111825717	5-氯-N4-[2-(二甲基磷酰基)苯基]-N2-{2-甲氧基-4-[4-(4-甲基哌嗪-1-基)哌啶-1-基]苯基}嘧啶-2,4-二胺的晶形 (Crystalline forms of 5-chloro-N4-[-2-(dimethylphosphoryl) phenyl]-N2-{2-methoxy-4-[4-(4-methylpiperazin-1-yl) piperidin-1-yl] pyrimidine-2,4-diamine)
South Korea	20160132127	키나아제 억제제로서 포스포러스 유도체 (PHOSPHOROUS DERIVATIVES AS KINASE INHIBITORS)
China	111888368	5-氯-N4-[2-(二甲基磷酰基)苯基]-N2-{2-甲氧基-4-[4-(4-甲基哌嗪-1-基)哌啶-1-基]苯基}嘧啶-2,4-二胺的晶形 (Crystalline forms of 5-chloro-N4-[-2-(dimethylphosphoryl) phenyl]-N2-{2-methoxy-4-[4-(4-methylpiperazin-1-yl) piperidin-1-yl] pyrimidine-2,4-diamine)
China	107108559	5‑氯‑N4‑[2‑(二甲基磷酰基)苯基]‑N2‑{2‑甲氧基‑4‑[4‑(4‑甲基哌嗪‑1‑基)哌啶‑1‑基]嘧啶‑2,4‑二胺的晶形 (Crystalline forms of 5-chloro-n4-[-2-(dimethylphosphoryl) phenyl]-n2-{2-methoxy-4-[4-(4-methylpiperazin-1-yl) piperidin-1-yl] pyrimidine-2,4-diamine)

Supplementary Protection Certificates for BRIGATINIB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2300013	1990030-7	Sweden		PRODUCT NAME: BRIGATINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/18/1264 20181126
2300013	132019000000069	Italy		PRODUCT NAME: BRIGATINIB, O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(ALUNBRIG); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1264, 20181126
2300013	31/2019	Austria		PRODUCT NAME: BRIGATINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1264 (MITTEILUNG) 20181126
2300013	2019C/525	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Brigatinib

Last updated: July 28, 2025

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Introduction

Brigatinib, marketed under the brand name ALUNBRIG, stands as a significant therapeutic agent in the treatment of ALK-positive non-small cell lung cancer (NSCLC). The drug’s emergence responds to a critical unmet need for targeted therapies capable of overcoming resistance mechanisms inherent in earlier-generation ALK inhibitors. This analysis explores the current market landscape, technological innovations, competitive positioning, and projected financial trajectory of brigatinib, essential for industry stakeholders evaluating potential investment, licensing, or strategic alignment options.

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Market Landscape and Drivers

Leading Therapeutic Area: ALK-Positive NSCLC

ALK-positive NSCLC accounts for approximately 3-5% of all lung cancers [1], translating to a sizeable patient population globally, especially in regions with high smoking rates and aging demographics. The therapeutic niche is characterized by rapid diagnosis, personalized treatment protocols, and a high unmet need for agents overcoming resistance to first-line ALK inhibitors.

Key Competitors and Market Share

Brigatinib’s primary competition includes ASP3829 (generic ALK inhibitors like crizotinib, ceritinib, alectinib, and lorlatinib). The drug’s positioning as a second- and third-line therapy is reinforced by clinical data demonstrating superior efficacy in resistant ALK mutations [2]. Market reports project brigatinib to gradually command a growing share within the multi-billion-dollar NSCLC therapeutic market, estimated to reach approximately $20 billion globally by 2030 [3].

Regulatory and Clinical Milestones

The FDA approval of brigatinib in 2017 marked a pivotal milestone. Its approval for ALK-positive metastatic NSCLC, including treatment-naive cases, with subsequent indications expansion, underscores its evolving role. Ongoing Phase III trials seek to further define its position in frontline therapy, potentially broadening market penetration [4].

Pricing and Reimbursement Dynamics

Brigatinib commands a premium pricing tier aligned with targeted oncology agents, often exceeding $10,000 per month per patient. Reimbursement strategies heavily hinge on clinical efficacy, comparative effectiveness, and health technology assessments, especially in cost-sensitive markets like Europe and emerging economies [5].

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Technological and Developmental Trends

Resistance Mechanisms and Next-Generation Design

Resistance mutations such as G1202R diminish the efficacy of earlier ALK inhibitors. Brigatinib’s design allows it to target a broad spectrum of these mutations, maintaining activity where first-generation drugs fail [6]. This technological advantage sustains its competitive edge.

Combination Therapies and Personalized Medicine

Future research explores brigatinib as part of combination regimens with immunotherapies and anti-angiogenic agents. Precision diagnostics employing liquid biopsies are enhancing patient stratification, aligning with the personalized medicine trend that could improve outcomes and increase drug utilization [7].

Novel Formulations and Delivery

The development of optimized formulations could enhance bioavailability and adherence, potentially reducing costs associated with adverse events. Such innovations could extend the drug’s applicability in healthcare settings with resource constraints.

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Financial Trajectory and Market Outlook

Current Revenue Generation

Since its launch, brigatinib’s revenue trajectory reflects steady growth attributed to its increasing acceptance in second-line therapy. Global sales are estimated at approximately $300 million in 2022, with expectations of double-digit growth rates annually, driven by expanded indications and increased physician adoption [8].

Growth Drivers

• Expansion into First-Line Therapy: Results from ongoing Phase III trials could lead to regulatory filings for frontline use, significantly expanding market size.
• Registration in Emerging Markets: Competitive pricing and strategic partnerships could facilitate penetration into markets such as China and India, where NSCLC incidence is high.
• Biomarker-Driven Utilization: Growth in precision diagnostics will enhance patient targeting, optimizing treatment outcomes and healthcare expenditure.

Market Challenges

• Competitive Landscape: The presence of multiple ALK inhibitors necessitates continued clinical differentiation.
• Pricing Pressures: Payer resistance to high-cost targeted therapies may limit revenue in cost-sensitive healthcare systems.
• Resistance and Safety Profiles: Emerging resistance patterns or adverse events could necessitate combination therapies, impacting sales volume.

Long-Term Financial Outlook

Industry projections imply that brigatinib could achieve a compound annual growth rate (CAGR) of approximately 15% over the next five years, reaching revenues exceeding $600 million by 2027. The realization of its full market potential hinges on successful completion of pivotal trials, regulatory approvals, and market access strategies.

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Regulatory and Strategic Considerations

Maximizing financial growth will require proactive engagement with regulatory agencies, ensuring approval pathways for new indications and formulations. Additionally, strategic collaborations with academic institutions and biotech firms can streamline R&D efforts, facilitating innovations that maintain competitive relevance.

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Key Takeaways

• Brigatinib currently occupies a vital niche in the NSCLC treatment landscape, with evolving indications and a solid clinical efficacy profile.
• Market expansion relies on demonstrating superiority over competitors, securing approvals for first-line use, and penetrating emerging markets.
• Continued innovation in combination therapies and formulations enhances its clinical value proposition and market potential.
• Financial growth projections are robust, contingent upon successful clinical milestones, regulatory approvals, and market acceptance.
• Competitive positioning demands vigilant surveillance of resistance patterns, therapeutic advancements, and payer dynamics.

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FAQs

1. What distinguishes brigatinib from other ALK inhibitors?
   Brigatinib exhibits broad activity against a range of ALK resistance mutations, including G1202R, and offers a favorable safety profile, providing a strategic advantage over earlier-generation inhibitors.

2. How might ongoing clinical trials influence brigatinib’s market share?
   Successful results in Phase III trials for frontline therapy could expand its use, increasing sales and potentially positioning brigatinib as a preferred initial therapy for ALK-positive NSCLC.

3. What are the primary challenges to brigatinib’s commercial success?
   Key challenges include intense competition, high pricing pressures, resistance development, and payer reimbursement hurdles across different markets.

4. How does regional market access impact brigatinib’s revenue potential?
   Market access strategies, including pricing negotiations and regulatory approvals within key regions like North America, Europe, and Asia, directly influence revenue growth prospects.

5. What is the role of technological innovation in sustaining brigatinib's market position?
   Innovations in combination therapies, formulation improvements, and diagnostic integration will be pivotal in enhancing efficacy, safety, and patient adherence, sustaining its market relevance.

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References

[1] Siegel, R.L., et al. (2021). Cancer statistics, 2021. CA: A Cancer Journal for Clinicians.
[2] Shaw, A.T., et al. (2019). Brigatinib in ALK-positive non-small-cell lung cancer. NEJM.
[3] Global Market Insights. (2022). Oncology drug market report.
[4] U.S. Food and Drug Administration. (2017). Approval for ALUNBRIG (brigatinib).
[5] Oncology Reimbursement Strategies. (2020). Pricing and access in targeted therapies.
[6] Katayama, R., et al. (2015). G1202R mutation and resistance. Cancer Cell.
[7] Planchard, D., et al. (2018). Precision medicine in lung cancer. Nat. Rev. Clin. Oncol.
[8] IQVIA. (2022). Oncology Market Reports.