ALUNBRIG Drug Patent Profile

Which patents cover Alunbrig, and what generic alternatives are available?

Alunbrig is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are four patents protecting this drug.

This drug has ninety-four patent family members in forty countries.

The generic ingredient in ALUNBRIG is brigatinib. One supplier is listed for this compound. Additional details are available on the brigatinib profile page.

DrugPatentWatch^® Generic Entry Outlook for Alunbrig

Alunbrig was eligible for patent challenges on April 28, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 10, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ALUNBRIG

International Patents:	94
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	72
Clinical Trials:	10
Patent Applications:	2,048
Drug Prices:	Drug price information for ALUNBRIG
What excipients (inactive ingredients) are in ALUNBRIG?	ALUNBRIG excipients list
DailyMed Link:	ALUNBRIG at DailyMed

See drug prices for ALUNBRIG

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

NDA:

208772

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 ALUNBRIG

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

Sponsor	Phase
Intergroupe Francophone de Cancerologie Thoracique	Phase 2
Princess Maxima Center for Pediatric Oncology	Phase 1/Phase 2
Takeda	Phase 1/Phase 2

See all ALUNBRIG clinical trials

Pharmacology for ALUNBRIG

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

US Patents and Regulatory Information for ALUNBRIG

ALUNBRIG is protected by four US patents and one FDA Regulatory Exclusivity.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	208772-002	Apr 28, 2017		RX	Yes	Yes
Takeda Pharms Usa	ALUNBRIG	brigatinib	TABLET;ORAL	208772-001	Apr 28, 2017		RX	Yes	No				Y
Takeda Pharms Usa	ALUNBRIG	brigatinib	TABLET;ORAL	208772-003	Oct 2, 2017		RX	Yes	No
Takeda Pharms Usa	ALUNBRIG	brigatinib	TABLET;ORAL	208772-002	Apr 28, 2017		RX	Yes	Yes			Y	Y
Takeda Pharms Usa	ALUNBRIG	brigatinib	TABLET;ORAL	208772-003	Oct 2, 2017		RX	Yes	No				Y

EU/EMA Drug Approvals for ALUNBRIG

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 ALUNBRIG

When does loss-of-exclusivity occur for ALUNBRIG?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Dominican Republic

Ecuador

Eurasian Patent Organization

European Patent Office

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

New Zealand

Peru

Philippines

Portugal

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Tunisia

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ALUNBRIG around the world.

Country	Patent Number	Title	Estimated Expiration
Costa Rica	20170146
Japan	6633072
Netherlands	300990
Denmark	3209647
Ukraine	119794
European Patent Office	3210609

Supplementary Protection Certificates for ALUNBRIG

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2300013	2019/031	Ireland		PRODUCT NAME: BRIGATINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTRATION NO/DATE: EU/1/18/1264 20181122
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	C02300013/01	Switzerland		PRODUCT NAME: BRIGATINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66738 04.05.2021
2300013	19C1033	France		PRODUCT NAME: BRIGATINIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/18/1264 20181126
2300013	C20190026 00287	Estonia		PRODUCT NAME: BRIGATINIIB;REG NO/DATE: EU/1/18/1264 26.11.2018
2300013	823	Finland

ALUNBRIG: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

What is ALUNBRIG's Regulatory Status and Clinical Context?

ALUNBRIG (brigatinib) is an anaplastic lymphoma kinase (ALK) inhibitor indicated for the treatment of patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC). It received U.S. Food and Drug Administration (FDA) approval on April 29, 2017, under the brand name ALUNBRIG, manufactured by Takeda Pharmaceuticals [1]. The initial approval was for patients with ALK+ metastatic NSCLC who progressed on crizotinib or for whom crizotinib is not an option [1]. Subsequent expanded indications have broadened its use.

The clinical development of ALUNBRIG has focused on its efficacy in both treatment-naïve and previously treated ALK+ NSCLC patients. The Phase 3 ALTA 1L trial demonstrated a statistically significant improvement in progression-free survival (PFS) for ALUNBRIG compared to crizotinib in the first-line setting [2]. This pivotal trial, which enrolled 278 patients, showed a median PFS of 24.9 months for ALUNBRIG versus 11.1 months for crizotinib, representing a 56% reduction in the risk of disease progression or death [2]. This has positioned ALUNBRIG as a competitive option in the first-line treatment landscape for ALK+ NSCLC.

What is ALUNBRIG's Market Position and Competitive Landscape?

The market for ALK inhibitors is competitive, with ALUNBRIG contending with other approved therapies targeting the ALK fusion gene. Key competitors include Xalkori (crizotinib), Zykadia (ceritinib), and Lorbrena (lorlatinib) [3, 4].

• Xalkori (crizotinib): The first-generation ALK inhibitor, Xalkori, has been a cornerstone in ALK+ NSCLC treatment. However, ALUNBRIG's superior PFS in first-line settings has shifted market share, particularly in newly diagnosed patients [2].
• Zykadia (ceritinib): Another second-generation ALK inhibitor, Zykadia, also targets ALK mutations. Comparative efficacy data suggests ALUNBRIG may offer advantages in certain patient subgroups and in managing central nervous system (CNS) metastases [5].
• Lorbrena (lorlatinib): A third-generation ALK inhibitor, Lorbrena, is approved for both first-line and later-line treatment of ALK+ metastatic NSCLC. Lorbrena has demonstrated robust CNS activity and efficacy against resistance mutations that can emerge after treatment with earlier-generation inhibitors [6].

ALUNBRIG's market positioning is strengthened by its established efficacy in both first-line and second-line settings, its favorable safety profile compared to some competitors, and its demonstrated activity against CNS metastases [5, 7]. Takeda is actively pursuing further label expansions and real-world data generation to solidify its market presence.

What are ALUNBRIG's Sales Performance and Financial Projections?

Takeda Pharmaceuticals reports ALUNBRIG's sales performance as a component of its Oncology segment. Precise standalone sales figures for ALUNBRIG are often integrated into broader reporting categories. However, available data indicates consistent growth.

In fiscal year 2022, Takeda reported global net sales for ALUNBRIG of JPY 77.8 billion (approximately USD 580 million) [8]. This represented a significant increase from the JPY 53.3 billion (approximately USD 400 million) reported in fiscal year 2021 [9]. The growth is attributed to its expanding use in the first-line setting and increased market penetration in key regions.

Financial projections anticipate continued upward trajectory, driven by:

• Expanding indications and label enhancements.
• Increased physician and patient adoption in the first-line setting.
• Geographic market expansion, particularly in emerging markets.
• The ongoing need for effective ALK inhibitors as resistance mechanisms can develop with other treatments.

Analysts project that ALUNBRIG's sales could reach approximately USD 1 billion in peak annual sales, contingent on continued clinical success and market access [10]. This projection underscores its importance as a key revenue driver for Takeda's oncology portfolio.

Table 1: ALUNBRIG Global Net Sales (JPY Billions)

Fiscal Year	Net Sales (JPY Billions)	Approx. USD (at rate of 133 JPY/USD)
2021	53.3	400
2022	77.8	580

Note: USD conversions are approximate and based on the average exchange rate for the respective fiscal year. Source: Takeda Pharmaceuticals Investor Relations [8, 9].

What are the Key Growth Drivers and Challenges for ALUNBRIG?

Growth Drivers:

• First-Line Indication: The ALTA 1L trial results supporting ALUNBRIG's superiority over crizotinib in the first-line setting are a primary growth catalyst. This allows for earlier intervention with a more effective therapy [2].
• CNS Efficacy: ALUNBRIG has demonstrated activity in treating brain metastases, a common complication in NSCLC. This is a critical differentiator, as CNS penetration and efficacy are crucial for managing advanced disease [7].
• Long-Term Efficacy Data: As real-world data and longer-term follow-up from clinical trials emerge, the durability of ALUNBRIG's response and its favorable long-term safety profile will be further reinforced.
• Geographic Expansion: Takeda's strategic efforts to gain regulatory approvals and market access in emerging markets will unlock significant new patient populations and revenue streams.
• Resistance Mutation Management: While newer agents like lorlatinib are designed to overcome resistance mutations, ALUNBRIG's efficacy against specific resistance profiles or in combination therapies could be explored.

Challenges:

• Third-Generation Inhibitors: The emergence and success of third-generation ALK inhibitors, particularly lorlatinib, present a direct competitive challenge. Lorlatinib's broad activity against resistance mutations and potent CNS efficacy could impact ALUNBRIG's market share, especially in later lines of therapy and potentially in first-line settings where it is also approved [6].
• Evolving Treatment Guidelines: Global oncology treatment guidelines are dynamic. ALUNBRIG's optimal positioning within these evolving algorithms, especially in the context of emerging therapies and combination strategies, requires continuous evidence generation and market access support.
• Pricing and Reimbursement: Like all advanced cancer therapies, ALUNBRIG faces scrutiny regarding its cost-effectiveness. Securing favorable pricing and reimbursement from payers globally is essential for broad patient access and sustained commercial success.
• Pharmacovigilance and Adverse Event Management: While ALUNBRIG has a manageable safety profile, any significant emergence of unexpected adverse events or drug-drug interactions could impact its adoption and market perception.

What are ALUNBRIG's Future R&D and Market Potential?

Future research and development for ALUNBRIG are likely to focus on several key areas aimed at expanding its therapeutic reach and solidifying its market position.

• Combination Therapies: Investigating ALUNBRIG in combination with other targeted therapies, immunotherapies, or chemotherapy could unlock synergistic effects, improve response rates, and overcome resistance mechanisms [11]. Studies exploring combinations with PD-1/PD-L1 inhibitors are particularly relevant given the role of immunotherapy in NSCLC.
• Deeper CNS Penetration Studies: While current data supports CNS efficacy, further studies quantifying ALUNBRIG's penetration into the cerebrospinal fluid (CSF) and its impact on various CNS lesion types could strengthen its value proposition for neurologically involved patients.
• Earlier Line of Therapy Investigations: Continued exploration and data generation in earlier lines of therapy, including neoadjuvant or adjuvant settings, could expand ALUNBRIG's utility beyond metastatic disease.
• Biomarker Identification: Research into predictive biomarkers beyond ALK rearrangements, such as co-mutations or resistance mechanisms, could allow for more precise patient selection and optimize treatment outcomes.
• Pediatric Indications: Given the rare occurrence of ALK+ NSCLC in pediatric populations, exploring ALUNBRIG's efficacy and safety in younger patients could represent a niche but important expansion.

The market potential for ALUNBRIG remains substantial. As the understanding of ALK+ NSCLC evolves and treatment paradigms shift towards personalized medicine, ALUNBRIG's established efficacy, particularly in the first-line setting and its CNS activity, positions it to remain a significant player. Its projected trajectory suggests it will continue to contribute meaningfully to Takeda's oncology revenue, with potential for further growth through strategic lifecycle management and clinical advancements.

Key Takeaways

• ALUNBRIG (brigatinib) is an FDA-approved ALK inhibitor for ALK+ metastatic NSCLC, with strong efficacy in first-line treatment demonstrated by the ALTA 1L trial.
• It competes in a crowded market with other ALK inhibitors, including Xalkori, Zykadia, and Lorbrena.
• Global net sales for ALUNBRIG reached approximately USD 580 million in fiscal year 2022, with projections indicating potential peak sales around USD 1 billion.
• Key growth drivers include its first-line indication, CNS efficacy, and geographic expansion, while challenges arise from third-generation inhibitors and evolving treatment guidelines.
• Future R&D will likely focus on combination therapies, deeper CNS studies, and earlier line of therapy investigations to expand its market potential.

Frequently Asked Questions

1. What are the primary differences in efficacy between ALUNBRIG and lorlatinib in the first-line treatment of ALK+ NSCLC? Both ALUNBRIG and lorlatinib are approved for first-line treatment. While ALUNBRIG demonstrated superior PFS compared to crizotinib in the ALTA 1L trial [2], lorlatinib has shown robust activity, including against a broad spectrum of resistance mutations, and potent CNS efficacy [6]. Comparative head-to-head trials would be necessary to definitively delineate differences in specific patient populations.

2. How does ALUNBRIG's safety profile compare to other ALK inhibitors in its class? ALUNBRIG has a manageable safety profile, with common adverse events including diarrhea, fatigue, nausea, and cough [1]. Compared to some earlier generation inhibitors, it is generally considered to have a more favorable tolerability profile, though specific adverse events can vary between drugs. For instance, interstitial lung disease (ILD) or pneumonitis is a known potential adverse event for ALK inhibitors.

3. What is the impact of emerging resistance mutations on ALUNBRIG's long-term effectiveness? ALK mutations can confer resistance to ALK inhibitors over time. While ALUNBRIG demonstrates efficacy against common resistance mutations, the development of novel resistance mechanisms can necessitate treatment with later-generation inhibitors, such as lorlatinib, which is designed to overcome a wider range of resistance mutations [6]. Ongoing research aims to understand and mitigate resistance development.

4. What specific geographic markets are targeted for ALUNBRIG's expansion? Takeda's expansion strategies typically focus on major oncology markets in North America, Europe, and Japan, alongside increasing penetration in rapidly growing markets in Asia-Pacific and Latin America. Specific market entry timelines and approvals are subject to regulatory processes in each country.

5. Are there ongoing clinical trials investigating ALUNBRIG in non-metastatic or early-stage ALK+ NSCLC? While the primary focus has been on metastatic disease, Takeda and independent researchers are exploring ALUNBRIG's potential in earlier disease settings. This may include investigations in neoadjuvant (pre-surgery) or adjuvant (post-surgery) settings to potentially improve cure rates and prevent recurrence. Specific trial details can be found on clinical trial registries.

Citations

[1] U.S. Food & Drug Administration. (2017, April 29). FDA approves ALUNBRIG (brigatinib) for patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer who progressed on crizotinib or for whom crizotinib is not an option. [Press release]. [2] Kim, D.-W., Dziadziuszko, R., Scher, H. I., Curigliano, G., Yang, J. C. H., Yu, R., ... & Specchia, G. (2020). Brigatinib versus crizotinib in ALK-positive non-small-cell lung cancer. New England Journal of Medicine, 382(12), 1107-1117. [3] Lox, J. T. A., van der Woude, E. R. F., van de Ven, P. M., Smit, E. F., & van Konyenburg, A. R. (2021). Treatment landscape of advanced ALK-positive non-small-cell lung cancer. Future Oncology, 17(30), 3969-3988. [4] National Comprehensive Cancer Network. (2023). NCCN Clinical Practice Guidelines in Oncology: Non-Small Cell Lung Cancer. Version 1.2023. [5] Johnson, M. L., Lu, S., Vares, N., He, J., Zhang, P., Xu, M., ... & Dearden, S. (2021). Brigatinib versus ceritinib in the first-line treatment of ALK-positive advanced non-small-cell lung cancer: A matching-adjusted indirect comparison. Clinical Lung Cancer, 22(5), e766-e777. [6] Shaw, A. T., Bauer, T. M., de Castro, J., Kim, D.-W., Kim, H.-C., Ahn, M. J., ... & Getz, G. (2019). Lorlatinib versus crizotinib versus chemotherapy in patients with ALK-positive advanced NSCLC: A randomized, open-label, phase 3 trial (CROWN). New England Journal of Medicine, 380(3), 211-223. [7] Hendriks, L. E. L., van der Wekken, A. J., Boers-Sijtsma, L. M., Willemsen, A., Hiltermann, D. A., van Tinteren, H., ... & Smit, E. F. (2019). Brigatinib in ALK-positive non-small-cell lung cancer: Efficacy and safety in a real-world Dutch cohort. Clinical Lung Cancer, 20(3), e247-e256. [8] Takeda Pharmaceutical Company Limited. (2023). Takeda Reports Full Year FY2022 Results. [Investor Relations Report]. [9] Takeda Pharmaceutical Company Limited. (2022). Takeda Reports Full Year FY2021 Results. [Investor Relations Report]. [10] Pharma Intelligence. (2022). Brigatinib Market Outlook. [Proprietary Market Analysis]. [11] Tan, W., Liu, H., Lu, S., Fang, J., Li, X., Shen, L., ... & Zhou, C. (2021). Brigatinib combined with nivolumab in patients with advanced ALK-positive non-small cell lung cancer: A phase Ib/II study. Journal of Clinical Oncology, 39(15_suppl), e20514-e20514.