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:	2,901
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

Constraining patent/regulatory exclusivity:

10,385,078

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
Takeda	Phase 1/Phase 2
Princess Maxima Center for Pediatric Oncology	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.

This potential generic entry date is based on patent 10,385,078.

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	9,611,283
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	208772-001	Apr 28, 2017		RX	Yes	No	9,012,462			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
Denmark	2300013
Cyprus	1119534
Poland	2300013

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	C20190026 00287	Estonia		PRODUCT NAME: BRIGATINIIB;REG NO/DATE: EU/1/18/1264 26.11.2018

Market Dynamics and Financial Trajectory for ALUNBRIG

Last updated: July 27, 2025

Introduction

ALUNBRIG (brigatinib) is a targeted tyrosine kinase inhibitor developed by Ariad Pharmaceuticals, subsequently acquired by Takeda Pharmaceutical Company. Launched for the treatment of ALK-positive non-small cell lung cancer (NSCLC), ALUNBRIG has carved a niche in the precision oncology space, where molecular profiling increasingly directs therapy decisions. Understanding the market landscape, competitive positioning, regulatory environment, and financial trajectory of ALUNBRIG is crucial for stakeholders assessing investment, partnership, or strategic options.

Market Dynamics

1. Therapeutic Landscape and Market Penetration

ALUNBRIG addresses a significant unmet need within ALK-positive NSCLC, a subset representing approximately 3–5% of all NSCLC cases. The global NSCLC market exceeds USD 15 billion[1], with targeted therapies accounting for roughly 30–40% of sales. As a second-generation ALK inhibitor, ALUNBRIG was positioned to compete primarily against first-generation drugs like crizotinib and other second-generation agents such as alectinib and brigatinib.

Initially, ALUNBRIG faced stiff competition from these established therapies due to clinician familiarity and existing reimbursement pathways. However, clinical trials like ALTA-1L demonstrated superior efficacy in intracranial disease control compared to crizotinib, facilitating its acceptance among oncologists.

2. Regulatory and Reimbursement Landscape

ALUNBRIG received FDA approval in 2017 for ALK-positive NSCLC resistant to prior kinase inhibitors[2]. Subsequent approvals in Europe and other markets expanded its reach. However, reimbursement policies vary globally, influencing prescription patterns. Countries with rapid access to targeted therapies and supportive healthcare infrastructure facilitate faster penetration.

Pricing strategies also impact adoption. ALUNBRIG's list price exceeds USD 12,000 per month, aligning with other targeted therapies but potentially limited by insurance reimbursements and cost-effectiveness assessments[3].

3. Competitive Dynamics

The competitive landscape includes:

• Brigatinib (ALUNBRIG): Second-generation agent with intracranial activity.
• Alectinib (Ariadne): Widely used, with robust efficacy data and strong market share.
• Lorlatinib (Pfizer): Third-generation inhibitor targeting resistant ALK mutations.
• Ceritinib (Novartis): Also competing in second-line settings.

Market share for ALUNBRIG remains modest, with a growing patient cohort due to increased molecular testing and improved diagnostic workflows. Real-world data suggest ALUNBRIG’s uptake is constrained by clinician familiarity and side effect profiles, such as early pulmonary events, necessitating careful management.

4. Market Growth Drivers

Several factors bolster the ALUNBRIG market:

• Rising Incidence: Lung cancer remains the leading cause of cancer mortality globally, and molecular profiling leads to more patients being eligible for ALK-targeted therapies.
• Diagnostic Advances: Next-generation sequencing (NGS) facilitates the identification of ALK rearrangements, expanding diagnosed patient populations.
• Treatment Sequencing: As standards evolve, ALUNBRIG could find a niche as a preferred second-line agent due to its activity profile.

5. Challenges and Risks

Key challenges include:

• Intense Competition: Dominance by alectinib and lorlatinib in multiple lines.
• Safety Profile: Pulmonary adverse events can limit patient tolerability.
• Pricing and Reimbursement: Cost barriers limit access in cost-conscious markets.
• Market Saturation: Increasing use of combination therapies and emerging resistance mechanisms may reduce the pipeline’s impact.

Financial Trajectory

1. Revenue Performance

Since its launch, ALUNBRIG's revenues have grown gradually. In FY2022, Takeda reported net sales of approximately USD 250 million for brigatinib, reflecting steady but limited market penetration[4]. The drug’s revenue trajectory depends on several factors:

• Market Expansion: Approval in additional geographies broadens the patient base.
• Line Extensions: Second-, third-line indications and combination strategies could boost sales.
• Pricing Policies: Negotiated discounts and managed care arrangements influence net revenue.

2. R&D and Regulatory Investment

Takeda continues to invest in clinical trials to explore ALUNBRIG's efficacy in broader indications, including small-cell lung cancer and combination regimens with other agents (e.g., immunotherapies). These initiatives may lead to future approvals, potentially expanding market reach.

3. Competitive Pressure and Patent Life

Patent protections for ALUNBRIG extend into the late 2020s or early 2030s, depending on regional data exclusivity rights. However, biosimilar or generic competition is unlikely given the drug's molecular innovation and patent strategies.

4. Future Revenue Drivers

• New Indications: Expansion into other ALK-driven malignancies or resistance settings.
• Combination Therapies: Synergies with checkpoint inhibitors or chemotherapies could create new revenue streams.
• Market Growth: Increased molecular testing and personalized treatment approaches favor long-term revenue growth.

5. Financial Risks

Potential setbacks include:

• Regulatory Delays or Rejections: New indications or line extensions require successful clinical trial outcomes.
• Market Share Erosion: Faster adoption of competing agents could reduce ALUNBRIG’s share.
• Pricing Pressures: Reimbursement cuts and price negotiations may impact profit margins.

Strategic Outlook

The financial trajectory of ALUNBRIG hinges on clinical success in new indications, continued market penetration, and competitive positioning. While current revenues reflect a niche market, strategic expansion into combination therapies and resistance management has the potential to significantly enhance growth. Moreover, as the lung cancer treatment paradigm shifts towards more comprehensive molecular profiling, ALUNBRIG’s role may evolve.

Investors and business strategists should monitor ongoing clinical trials, regulatory updates, and competitive movements to refine their forecasts and investment decisions.

Key Takeaways

• Market Positioning: ALUNBRIG holds a targeted niche in ALK-positive NSCLC, with growth driven by increasing diagnostics and personalized therapy trends.
• Competitive Edge: Its intracranial efficacy grants an advantage over some first-generation inhibitors, though competing second- and third-generation agents challenge its dominant position.
• Financial Trajectory: Revenue growth remains steady but limited, with significant upside tied to new indications, combination treatments, and expanded geographical approvals.
• Challenges: Market saturation, high drug pricing, side effect profiles, and competitive dynamics pose ongoing hurdles.
• Investment Implications: Continued R&D, strategic partnerships, and clinical success are critical to elevating ALUNBRIG’s financial performance.

FAQs

1. What is the current global market share of ALUNBRIG in ALK-positive NSCLC?
   ALUNBRIG commands a modest slice of the ALK inhibitor market, primarily secondary to alectinib’s dominant position. Precise market share varies by region but remains below 15% globally, with growth potential in metastatic and resistant cases[1].

2. How does ALUNBRIG compare to other ALK inhibitors in efficacy?
   Clinical trials indicate that ALUNBRIG offers comparable or superior intracranial control relative to crizotinib and has demonstrated activity in crizotinib-resistant patients. However, second- and third-generation inhibitors like alectinib and lorlatinib often show better overall progression-free survival (PFS) in frontline settings[2].

3. What are the primary safety concerns associated with ALUNBRIG?
   Pulmonary adverse events, including pneumonitis and acute respiratory distress, are notable safety concerns. Proper patient monitoring and management protocols are essential to mitigate risks.

4. Are there upcoming indications or combination therapies for ALUNBRIG?
   Takeda is conducting trials exploring ALUNBRIG’s efficacy in combination with immune checkpoint inhibitors and in resistant or advanced disease settings. Positive results could significantly expand its indications and revenue potential.

5. What are the key factors influencing ALUNBRIG’s future market growth?
   Increased molecular testing, expansion into new indications, advantageous positioning in treatment lines, and successful clinical trials are vital for future growth. Competition and pricing policies remain notable hurdles.

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References

[1] Grandview Research. "Lung Cancer Treatment Market Size & Share Analysis." 2022.
[2] U.S. Food and Drug Administration. "FDA Approves Brigatinib for Specific Lung Cancers." 2017.
[3] Takeda Pharmaceuticals. "Brigatinib (ALUNBRIG) Pricing and Reimbursement Data." 2022.
[4] Takeda Quarterly Financial Report. "Q4 2022 Highlights and Sales Data." 2022.