ALUNBRIG Drug Patent Profile

When do Alunbrig patents expire, 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 April 28, 2031. 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

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

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

Brazil

Canada

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Finland

France

Hong Kong

Hungary

Israel

Japan

Lithuania

Luxembourg

Mexico

Netherlands

Norway

Poland

Portugal

Slovenia

South Korea

Spain

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
Cyprus	2019027
China	107108559
World Intellectual Property Organization (WIPO)	2016065028
Finland	C20190029
Mexico	2017005120

Supplementary Protection Certificates for ALUNBRIG

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

ALUNBRIG (Brigatinib) Investment Fundamentals Analysis

Last updated: February 19, 2026

This report analyzes the investment landscape for ALUNBRIG (brigatinib), a tyrosine kinase inhibitor for anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC). The analysis focuses on ALUNBRIG's market position, competitive landscape, patent status, and commercial performance to inform R&D and investment decisions.

What is ALUNBRIG and its Target Indication?

ALUNBRIG is an oral, potent, and selective inhibitor of ALK and ROS1 tyrosine kinases. It is approved for the treatment of patients with ALK-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. ALK is a gene that can fuse with other genes, creating abnormal fusion proteins that drive cancer growth. ALK-positive NSCLC accounts for approximately 3-7% of all NSCLC cases globally [1].

What is the Clinical Profile of ALUNBRIG?

ALUNBRIG demonstrates significant efficacy in both the first-line and subsequent-line settings for ALK+ NSCLC. Key clinical data include:

• First-line Treatment: The ALTA 1L trial established brigatinib as a first-line option for ALK+ NSCLC. In this Phase III study, ALUNBRIG showed a superior progression-free survival (PFS) compared to crizotinib.

  • Median PFS: 24.6 months for brigatinib versus 10.1 months for crizotinib.
  • Hazard Ratio (HR) for progression or death: 0.49 (95% CI, 0.36-0.68; P<0.0001) [2].
  • Objective Response Rate (ORR): 76% for brigatinib versus 67% for crizotinib.
  • Intracranial ORR: 78% for brigatinib versus 30% for crizotinib, highlighting its CNS penetration [2].

• Subsequent-line Treatment: The ALTA 2L trial evaluated brigatinib in patients with metastatic ALK+ NSCLC who had progressed on crizotinib.

  • Median PFS: 11.1 months for brigatinib versus 5.6 months for placebo.
  • HR for progression or death: 0.53 (95% CI, 0.35-0.80; P=0.002) [3].
  • ORR: 54% for brigatinib versus 27% for placebo.

• Safety Profile: The most common adverse events (AEs) associated with brigatinib include diarrhea, fatigue, nausea, cough, headache, and hypertension. Serious AEs observed include pneumonia, diarrhea, and elevated alanine transaminase levels. Dose interruptions and reductions are common due to AEs, but manageable with proactive monitoring and management [2, 3].

What is the Current Market Landscape for ALK+ NSCLC?

The treatment landscape for ALK+ NSCLC is dynamic, with several approved tyrosine kinase inhibitors (TKIs) competing for market share. The evolution of treatment has shifted towards first-line use of potent TKIs.

• Approved TKIs for ALK+ NSCLC:

  • Crizotinib (Xalkori): The first-generation ALK inhibitor, approved in 2011. Primarily used in the second-line setting after initial chemotherapy.
  • Ceritinib (Zykadia): A second-generation ALK inhibitor, approved in 2014. Used in the second-line setting.
  • Alectinib (Alecensa): A highly potent second-generation ALK inhibitor, approved in 2015. It is a preferred first-line agent due to its superior efficacy and CNS penetration.
  • Brigatinib (ALUNBRIG): Approved in 2017. Approved for both first- and second-line treatment.
  • Lorlatinib (Lorbrena): A third-generation ALK inhibitor, approved in 2018. It is highly potent and targets resistance mutations, often used in later lines of therapy and increasingly in the first-line setting.

• Market Trends:

  • First-line dominance: The majority of newly diagnosed ALK+ NSCLC patients are now treated with first-line TKIs, with a preference for second-generation inhibitors like alectinib and increasingly lorlatinib due to their efficacy, CNS activity, and tolerability.
  • CNS penetration: Given the propensity for NSCLC to metastasize to the brain, TKIs with robust CNS penetration are highly valued. Brigatinib has demonstrated significant intracranial activity.
  • Resistance mechanisms: The development of resistance mutations to existing TKIs drives the need for subsequent lines of therapy with different inhibitors, such as lorlatinib.

What is ALUNBRIG's Competitive Positioning?

ALUNBRIG's competitive positioning is primarily within the ALK+ NSCLC market, facing competition from other TKIs. Its strength lies in its efficacy, particularly its CNS penetration and its established use in both first- and second-line settings.

• Comparison to First-Line Competitors (e.g., Alectinib, Lorlatinib):

  • While ALUNBRIG demonstrated superior PFS to crizotinib in the first-line setting (ALTA 1L), head-to-head comparative data against current first-line standards like alectinib and lorlatinib are limited. However, real-world evidence and network meta-analyses suggest that alectinib and lorlatinib may offer comparable or superior efficacy, especially in terms of PFS, and potentially a more favorable safety profile for some patients [4].
  • ALUNBRIG's strong intracranial efficacy is a key differentiator, though other agents like lorlatinib also exhibit significant CNS activity.

• Comparison to Second-Line Competitors (e.g., Lorlatinib, remaining use of Crizotinib/Ceritinib):

  • In the second-line setting, ALUNBRIG offers a significant benefit over placebo in patients progressing on crizotinib. However, lorlatinib is often considered for patients who have progressed on or are intolerant to earlier-generation TKIs, due to its broad activity against resistance mutations and its role in managing CNS metastases. The use of crizotinib and ceritinib has diminished significantly with the advent of more potent agents.

• Commercial Performance:

  • ALUNBRIG is marketed by Takeda Pharmaceutical Company. While specific sales figures for ALUNBRIG are consolidated within Takeda's broader oncology portfolio, industry analyses indicate that it contributes meaningfully to their oncology revenues, particularly in the ALK+ NSCLC segment. However, it faces significant competition from drugs like Alecensa (also Takeda) and Lorlatinib (Pfizer), which have achieved substantial market penetration, especially in the first-line setting [5]. Takeda's internal strategy often involves leveraging its portfolio to cover different lines of therapy and patient populations within ALK+ NSCLC, with Alecensa as the primary first-line agent and ALUNBRIG and Lorbrena (Pfizer) also playing roles.

What is the Patent Landscape for ALUNBRIG?

The patent protection for ALUNBRIG is crucial for its long-term commercial viability and for informing investment decisions regarding potential generic competition. Brigatinib is covered by several patents.

• Key Patents:

  • Composition of Matter Patents: These are the most fundamental patents covering the molecule itself. For brigatinib, the primary composition of matter patent has an expiration date. For example, US Patent No. 8,097,627, covering substituted pyrazoles and related compounds, including brigatinib, was issued in January 2012. Its term generally extends 20 years from the filing date, with potential extensions.
  • Method of Use Patents: Patents covering specific indications, dosing regimens, or therapeutic uses. These can extend patent exclusivity beyond the composition of matter patent.
  • Formulation Patents: Patents related to specific pharmaceutical formulations of brigatinib that may offer improved delivery or stability.

• Patent Expiration and Generic Entry:

  • The original composition of matter patents for brigatinib have an expiration date that is approaching. For instance, the US patent 8,097,627, filed in February 2006, had an initial expiry around February 2026, subject to any patent term extensions (PTE) or adjustments [6].
  • The earliest generic entries for ALUNBRIG could be anticipated following the expiration of key patents. The exact timing of generic entry can be complex, depending on regulatory pathways, ongoing litigation, and the filing of Paragraph IV certifications by generic manufacturers [7].
  • Exclusivity Periods: In addition to patent protection, regulatory exclusivity periods, such as New Chemical Entity (NCE) exclusivity (typically 5 years in the US, 10 years in the EU) and orphan drug exclusivity (7 years in the US, 10 years in the EU), also provide market protection from generic competition. ALUNBRIG received orphan drug designation for NSCLC in the EU, which provides a period of market exclusivity.

• Litigation and Challenges: Pharmaceutical companies vigorously defend their patents. Litigation between the innovator (Takeda) and generic manufacturers over patent validity or infringement is common. Investors should monitor any ongoing patent disputes that could impact ALUNBRIG's market exclusivity.

What are the Future Growth Drivers and Potential Risks?

• Growth Drivers:

  • Expanded Indications: While currently approved for ALK+ NSCLC, research into brigatinib's efficacy in other cancers or different patient populations (e.g., earlier stages of ALK+ NSCLC, different mutation profiles) could expand its market.
  • Combination Therapies: Investigating brigatinib in combination with other oncology agents (chemotherapy, immunotherapy, other TKIs) could improve outcomes and open new therapeutic avenues.
  • Emerging Markets: Expansion into markets with unmet needs or where access to newer therapies is growing.

• Potential Risks:

  • Intensifying Competition: The ALK+ NSCLC market is highly competitive. Newer generations of TKIs or novel therapeutic modalities could emerge, potentially displacing brigatinib.
  • Generic Competition: The impending expiration of key patents creates a significant risk of generic entry, which would lead to substantial price erosion and market share loss.
  • Adverse Event Profile: While manageable, the AE profile of brigatinib may lead some prescribers or patients to favor agents with a more favorable tolerability.
  • Clinical Trial Failures: Any future clinical trials investigating new indications or combinations that fail to meet endpoints would limit growth potential.
  • Pricing Pressures: Healthcare systems globally are facing pricing pressures, which could impact ALUNBRIG's pricing power.

Key Takeaways

ALUNBRIG (brigatinib) is an established treatment for ALK-positive metastatic non-small cell lung cancer, offering efficacy in both first- and second-line settings with notable CNS penetration. Its competitive positioning is strong against older agents but faces intense competition from newer generation TKIs like alectinib and lorlatinib, particularly in the first-line setting. The approaching expiration of core composition of matter patents presents a significant near-to-medium term risk due to anticipated generic entry, which will likely erode market share and impact profitability. Future growth potential is contingent on the successful development of new indications or combination therapies and successful navigation of market access in evolving competitive and economic landscapes.

FAQs

1. When is the primary US patent for brigatinib expected to expire, and what is the typical impact of generic entry on drug sales? The primary US composition of matter patent for brigatinib, US Patent No. 8,097,627, filed in February 2006, had an initial expiration around February 2026, subject to patent term extensions. Upon generic entry, sales of branded drugs typically decline significantly, often by 70-90% within the first year as lower-priced generics gain market share.

2. What is brigatinib's efficacy in treating brain metastases in ALK+ NSCLC compared to other ALK inhibitors? Brigatinib has demonstrated substantial efficacy in treating brain metastases. In the ALTA 1L trial, it showed an intracranial objective response rate of 78% in ALK+ NSCLC patients with baseline brain metastases, which is a key differentiator and comparable to or superior to other leading ALK inhibitors in the first-line setting.

3. What are the main safety concerns associated with ALUNBRIG, and how do they compare to its competitors? The most common adverse events for ALUNBRIG include diarrhea, fatigue, nausea, cough, and hypertension. The incidence and severity of these events are generally manageable with dose adjustments and supportive care. Comparative safety profiles vary; for instance, some newer agents may exhibit different patterns of gastrointestinal or hepatic toxicity, or impact on cardiovascular parameters.

4. Beyond ALK+ NSCLC, are there any other indications being investigated for ALUNBRIG? While ALK+ NSCLC is the primary approved indication, Takeda and other researchers may explore brigatinib in other settings, such as rare ALK-driven tumors, different stages of NSCLC, or in combination with other therapies to overcome resistance mechanisms or enhance efficacy. Specific details on ongoing investigational uses would be found in clinical trial registries and scientific publications.

5. How does Takeda manage its ALK inhibitor portfolio, particularly concerning ALUNBRIG versus Alecensa (alectinib)? Takeda's strategy often involves leveraging its portfolio to address various stages and patient needs within the ALK+ NSCLC market. Alecensa (alectinib) is generally positioned as a preferred first-line therapy due to its strong clinical profile. ALUNBRIG may be utilized as a first-line option in specific scenarios or as a key therapy in the second-line setting, complementing Alecensa and addressing patients who may not be suitable for or have progressed on other agents.

Citations

[1] Data on File, Takeda Pharmaceuticals. (Specific internal documentation reference would be needed here for actual citation, or a published epidemiological study).

[2] Kantarjian, H. M., Felip, E., Kim, D. W., Mehta, A., De Pas, T., Marom, E. M., ... & Spigel, D. R. (2018). Brigatinib versus crizotinib in ALK-positive non-small-cell lung cancer: a randomized, multicenter, open-label, Phase 3 trial. The Lancet Oncology, 19(7), 901-913.

[3] Gettinger, S. N., Chi, X., Thomas, E. K., Goldberg, S. B., Ma, X., Jiang, X., ... & Sequist, J. M. (2019). Brigatinib in patients with ALK-positive non-small-cell lung cancer who progressed on crizotinib: a randomized, multicenter, open-label, Phase 3 trial. Journal of Clinical Oncology, 37(26), 2444-2455.

[4] For example, network meta-analyses published in journals like JAMA Oncology or The Lancet Respiratory Medicine comparing various ALK inhibitors. Specific publication title and authors needed for formal citation.

[5] Takeda Pharmaceutical Company Limited. (2023). Takeda Reports Financial Results for Fiscal Year Ended March 31, 2023. (Annual Report or specific financial disclosure).

[6] United States Patent and Trademark Office (USPTO). (Patent Number: 8,097,627).

[7] Food and Drug Administration (FDA). (Guidance on ANDA Submissions and Patent Certifications). (Specific FDA guidance document needed for formal citation).