Brigatinib - Generic Drug Details

What are the generic sources for brigatinib and what is the scope of freedom to operate?

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:	36
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
Tang-Du Hospital	PHASE1
Guangdong Association of Clinical Trials	PHASE3
University Health Network, Toronto	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	Yes	9,273,077
Takeda Pharms Usa	ALUNBRIG	brigatinib	TABLET;ORAL	208772-003	Oct 2, 2017		RX	Yes	No
Takeda Pharms Usa	ALUNBRIG	brigatinib	TABLET;ORAL	208772-003	Oct 2, 2017		RX	Yes	No	10,385,078		Y	Y
Takeda Pharms Usa	ALUNBRIG	brigatinib	TABLET;ORAL	208772-001	Apr 28, 2017		RX	Yes	No	9,012,462			Y
Takeda Pharms Usa	ALUNBRIG	brigatinib	TABLET;ORAL	208772-003	Oct 2, 2017		RX	Yes	No	9,273,077
Takeda Pharms Usa	ALUNBRIG	brigatinib	TABLET;ORAL	208772-001	Apr 28, 2017		RX	Yes	No	10,385,078		Y	Y
Takeda Pharms Usa	ALUNBRIG	brigatinib	TABLET;ORAL	208772-001	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
Japan	6271064
Eurasian Patent Organization	029131
World Intellectual Property Organization (WIPO)	2016065028
Japan	2011523646
Cyprus	2019027
Eurasian Patent Organization	201790892
Norway	2300013

Supplementary Protection Certificates for brigatinib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2300013	31/2019	Austria		PRODUCT NAME: BRIGATINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1264 (MITTEILUNG) 20181126
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	823	Finland
2300013	2019/031	Ireland		PRODUCT NAME: BRIGATINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTRATION NO/DATE: EU/1/18/1264 20181122
2300013	LUC00120	Luxembourg		PRODUCT NAME: BRIGATINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/18/1264 20181126
2300013	C201930036	Spain		PRODUCT NAME: BRIGATINIB, O SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO.; NATIONAL AUTHORISATION NUMBER: EU/1/18/1264; DATE OF AUTHORISATION: 20181122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1264; DATE OF FIRST AUTHORISATION IN EEA: 20181122

Market Dynamics and Financial Trajectory of Brigatinib

Last updated: February 13, 2026

Brigatinib is a targeted therapy developed by ALK gene rearrangement-positive non-small cell lung cancer (NSCLC) patients. It received FDA approval in April 2017 for metastatic ALK-positive NSCLC previously treated with crizotinib, and subsequent approvals expanded its use to first-line settings.

Market Overview

Therapeutic Indications and Approvals

• Initial Approval (2017): Treatment of ALK-positive metastatic NSCLC following crizotinib.
• Expanded Use: Approved in 2020 for first-line treatment of ALK-positive NSCLC.
• Additional Indications: Ongoing trials explore activity in other ALK-driven cancers.

Competitive Landscape

• Key competitors: Alectinib, ceritinib, lorlatinib, and brigatinib itself are main therapies targeting ALK-positive NSCLC.
• Market positioning: Brigatinib distinguishes itself with a comparable or superior efficacy profile, especially in patients with CNS metastases, and a tolerable safety profile.

Market Size and Forecast

Current Market Value

• The global NSCLC targeted therapy market was valued at approximately $7.3 billion in 2022.
• ALK inhibitors account for roughly 20% of this market, translating to $1.46 billion in 2022.

Growth Drivers

• Rising incidence of lung cancer globally, estimated at 2.2 million new cases in 2020.
• Increased adoption of molecular diagnostics for targeted therapy selection.
• Broader approval for frontline treatment expands the patient pool.

Projected Market Growth

• The ALK inhibitor segment is expected to grow at a compound annual growth rate (CAGR) of approximately 12% from 2023 to 2030.
• By 2030, the market valuation for brigatinib-related therapies may exceed $4 billion, assuming market share gains and increased adoption.

Revenue and Sales Trajectory

Historical Sales Data (2020-2022)

• Estimated sales of brigatinib in 2020: $150 million.
• Revenue increased to approximately $350 million in 2022, driven by expanded indications and market penetration.

Forecasts (2023-2030)

Year	Estimated Sales (USD Millions)	Notes
2023	$500	Growing adoption, expanded access
2025	$1,000	Increased uptake, competitive positioning
2030	$3,500–$4,000	Market expansion, global reach

Factors Influencing Market Dynamics

• Pricing Strategies: Targeted therapies like brigatinib often carry premium pricing, with list prices ranging from $10,000 to $15,000 per month, depending on dosage and region.
• Reimbursement Policies: Coverage varies across regions; reimbursement hurdles can curb adoption.
• Regulatory Environment: Approvals in emerging markets and ongoing clinical trials to broaden indications influence future sales.
• Manufacturing and Supply Chain: Consistent supply is critical; disruptions can impact sales forecast.

Financial Risks and Opportunities

• Patent Expiry and Competition: Patent expiration could open access for generics, pressuring prices but also expanding accessible patient populations.
• Pipeline Development: Efficacy in combination therapies and new indications can generate additional revenue streams.
• Market Penetration: Competitive positioning relative to other ALK inhibitors affects sales; brand loyalty and physician preferences play roles.

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Key Takeaways

• Brigatinib has a growing market presence in ALK-positive NSCLC, with sales projected to continue increasing through 2030.
• The expanding patient pool, driven by broader indications and improved diagnostics, underpins long-term growth.
• Price points and reimbursement policies remain potential hurdles; patent protections currently defend market exclusivity.
• Competition among ALK inhibitors influences pricing and market share.
• Pipeline progress and combination strategies could generate additional revenue.

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FAQs

1. What factors contributed to brigatinib's market expansion?
Expanded indications, improved efficacy, and increased diagnostic testing for ALK mutations have driven its adoption.

2. How does brigatinib compare to competing ALK inhibitors?
It offers comparable efficacy with activity in CNS metastases and a manageable safety profile, differentiating it in specific patient subsets.

3. What are the main risks facing brigatinib's market growth?
Patent expiration, aggressive competition, and reimbursement hurdles can limit sales.

4. What future developments could influence brigatinib's financial trajectory?
New indications, combination therapies, and growth into emerging markets broaden revenue potential.

5. How does pricing impact brigatinib's market access?
High list prices beget reimbursement challenges, but payers accept premiums for superior outcomes; pricing strategies remain crucial.

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Sources

1. FDA Approvals — [1]
2. Market Value and Forecast Data — [2]
3. Competitive Landscape — [3]
4. Pricing and Reimbursement — [4]
5. Clinical Trials and Indications — [5]