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-five 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:	95
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	72
Clinical Trials:	10
Patent Applications:	2,345
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

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

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
Australia	2015335950
Canada	2965169
Chile	2017000979
China	107108559

Supplementary Protection Certificates for ALUNBRIG

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2300013	CA 2019 00028	Denmark		PRODUCT NAME: BRIGATINIB, ELLER ET FARMACEUTISK ACCEPTABELT SALT HERAF; REG. NO/DATE: EU/1/18/1264 20181126
2300013	300990	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
2300013	PA2019510	Lithuania		PRODUCT NAME: BRIGATINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; 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

Alunbrig (brigatinib) Market Dynamics and Financial Trajectory: Exclusivity, Patent Risk, Generic/Biosimilar Pressure, Pricing, and Revenue Outlook

Last updated: June 23, 2026

Alunbrig (brigatinib) is a US-market oncology asset with a shrinking window of patent and regulatory exclusivity risk driven by long-running formulation and use patent estates, with commercial performance concentrated in the ALK-positive NSCLC line. Revenue trajectory is shaped less by near-term biologic substitution risk and more by oral TKI class competition, sequencing behavior after first-line uptake of preferred regimens, payer steerage, and post-patent erosion in the event of ANDA and Paragraph IV outcomes.

What is Alunbrig (brigatinib) used for, and how does its positioning drive demand?

Alunbrig is an oral ALK inhibitor for ALK-positive non-small cell lung cancer (NSCLC). Its demand depends on (1) how it is sequenced after first-line therapy, (2) local treatment practice for ALK-positive disease, and (3) payer coverage of newer ALK agents that may displace brigatinib in particular patient segments.

Which lines of therapy define Alunbrig revenue exposure?

Commercial exposure is primarily tied to post-diagnosis ALK-positive NSCLC treatment choices, including:

• First-line ALK-positive metastatic disease (where brigatinib competes with next-generation ALK inhibitors).
• Subsequent-line use after progression on prior ALK therapy.
• Treatment selection in patients with CNS activity needs, where the ALK portfolio’s clinical differentiation drives prescribing.

How do ALK TKI competitors affect market share?

Market dynamics are dominated by within-class switching:

• First-line penetration depends on clinician preference and guideline alignment among ALK TKIs.
• Post-progression demand depends on tolerance profiles, dose modifications, and availability under payer policies.
• Pricing pressure comes from plan formularies and preferred product lists in oncology.

When does Alunbrig lose exclusivity, and what does that mean for launch timing risk?

Exclusivity timing determines the probability of ANDA entry and the speed of generic erosion. For a branded oral oncology TKI, the most material drivers are:

• Composition-of-matter patent expirations.
• Extended exclusivity via regulatory exclusivity periods.
• Formulation and method-of-use patent coverage that can delay generic approvals or narrow design-around space.
• Patent litigation outcomes that can force “at-risk” timing changes.

What exclusivity milestones determine ANDA timing for brigatinib?

The practical exclusivity framework for Alunbrig is:

• Patent expiration of core active ingredient protection.
• Secondary patent coverage (formulations, dosing regimens, patient selection, method-of-treatment).
• FDA exclusivity labeling periods tied to new clinical studies or line extensions.
• Settlement agreements that can delay generic entry even after patent expiry.

What launch scenarios are typical if key patents expire or are invalidated?

Alunbrig’s financial trajectory is most sensitive to two generic/biosimilar scenarios:

• Scenario A: A single successful first Paragraph IV ANDA triggers a delayed erosion curve tied to 180-day exclusivity and payer uptake.
• Scenario B: Multiple challenges reduce the effective time to generic adoption through faster label-to-launch conversions and multi-brand competition.

How many patents protect Alunbrig, and which families drive the strongest barriers?

A defensible patent estate for an oncology TKI usually spans:

• Active ingredient composition and/or polymorph coverage.
• Pharmaceutical compositions (crystal form, salts if applicable, particle size, stability).
• Manufacturing/process claims.
• Methods of treatment and/or patient subgroup treatment.

What is the structure of Alunbrig’s patent moat (typical for this drug class)?

For brigatinib, protection commonly clusters into:

• Composition-of-matter families (base IP).
• Formulation-specific claims tied to oral dosage stability and bioavailability.
• Method-of-use claims that map to ALK-positive NSCLC clinical endpoints.

Which jurisdictions matter most for market erosion?

US is the primary erosion risk zone due to ANDA pathways and Orange Book listings:

• US: determines generic entry and post-approval sales pressure.
• Europe and Japan: can have slower erosion patterns but influence global revenue and negotiated pricing.

What patent litigation affects Alunbrig generic entry risk?

Patent litigation is a key driver of timing, settlement value, and the likelihood of an early or late generic launch. The financial impact is tied to:

• Case outcomes (invalidation, non-infringement, infringement findings).
• Stay/triggered triggers under Hatch-Waxman (automatic stays pending litigation).
• Settlement agreements that set “carve-out” dates or licensing terms.

How do Paragraph IV filings change financial trajectory for Alunbrig?

Paragraph IV events influence:

• Probability of an early ANDA approval date.
• Whether generic erosion happens with a single first entrant or multiple launches.
• Payer behavior if low-cost generics appear in branded formularies.

What is the Orange Book status of Alunbrig (brigatinib) and what does it signal?

Orange Book listings provide the formal mapping between:

• Listed patents
• Expiration dates
• Weakest links (earliest-expiring listed patents)
• The window for ANDA submission and potential Paragraph IV challenges

How does Orange Book coverage translate into sales protection?

In practice, Orange Book coverage affects:

• Time before a generic can rely on labeling carve-outs.
• Whether generics must launch “at risk” or await final resolution.
• Likelihood of design-around success for formulation and method-of-use claims.

How does Alunbrig compare with other ALK inhibitors on market share dynamics and pricing pressure?

Alunbrig’s financial path depends on its relative position among ALK inhibitors in both first-line and subsequent-line settings:

• If brigatinib is preferred in CNS-relevant subgroups, demand retention can be stronger even as new TKIs enter.
• If newer ALK agents shift guideline preference, brigatinib faces faster share loss.
• Oral TKI substitution is common, so payer formularies can quickly re-rank value based on negotiated pricing and budget impact.

What sequencing dynamics matter most for revenue decline?

Revenue erosion usually reflects:

• First-line displacement reducing new patient starts.
• Residual demand in later lines continuing longer, but shrinking as the treatable population shifts.
• Increased competitive contracting that compresses net price.

What formulations and dosing regimens are protected, and how do they affect generic design-around?

For oral oncology TKIs, design-around can focus on:

• Alternative crystal forms or solid-state forms (if claimed).
• Particle size and formulation parameters.
• Bioavailability-related composition rules.
• Dosing regimen claims, including administration timing and dose modifications tied to safety.

What is the impact of formulation patent strength on generic launch economics?

Formulation barriers affect financial trajectory by:

• Increasing time to ANDA approval.
• Raising development and equivalency costs.
• Allowing branded manufacturers to maintain higher effective net prices for longer.

What FDA regulatory pathway milestones shape Alunbrig’s commercialization curve?

Alunbrig’s commercialization timeline is shaped by:

• Initial NDA approval and subsequent label expansions (new indications or line-of-therapy updates).
• Safety communications that influence prescribing behavior and uptake.
• Post-marketing commitments that can affect manufacturing and supply stability.

How do label expansions influence revenue trajectory?

Label expansions typically:

• Increase eligible patient population.
• Support pricing and contracting leverage.
• Extend the period of clinical guideline inclusion.

What commercial metrics define Alunbrig’s financial trajectory in practice?

For a branded oral oncology drug, the dominant financial drivers are:

• Net sales vs. list price, driven by rebate and payer coverage.
• Growth from new starts vs. decline from displaced sequencing.
• Margin compression from competitive pricing and contract renegotiations.
• Product lifecycle stage: maturation phase vs. post-exclusivity risk.

What drives net sales changes quarter to quarter?

Net sales movement typically reflects:

• Seasonal supply and distribution timing.
• Recall or manufacturing disruptions (if any) affecting fills.
• Patient starts and retention relative to competitor TKIs.
• Payer formulary changes and 340B channel dynamics.

What generic entry risks exist for Alunbrig, and what is the likely erosion shape?

The financial impact of generic erosion depends on:

• Whether ANDA entrants launch immediately upon eligibility.
• Number of approved generic products.
• Formulary inclusion speed by major PBMs and Medicare Part D.
• Patient retention and prescriber switching behavior after branded loss.

How fast could erosion occur?

For specialty oral oncology:

• Erosion often accelerates after first generic entry, with payers moving to preferred low-cost options.
• Brand manufacturers may respond with price concessions, contract rebates, or patient support programs.
• Erosion slope differs by plan category and whether the drug remains preferred in key clinical protocols.

What is the company and ownership structure behind Alunbrig’s market performance?

Alunbrig is commercialized in the US by its brand holder under a specialty oncology model. The financial trajectory is influenced by:

• Manufacturing scale and supply assurance.
• Global development portfolio and capital allocation for next-gen pipeline.
• License and collaboration strategy for complementary oncology assets.

Key market dynamics checklist for Alunbrig investors and litigators

• Patent and Orange Book coverage governs timing and generic entry probability.
• Paragraph IV challenges and settlement terms drive launch date certainty or delay.
• Within-class ALK TKI competition governs demand share and net price erosion.
• Payer steerage determines post-launch adoption speed.
• Sequencing shifts after first-line uptake can compress future new starts even before patent expiry.

Key Takeaways

• Alunbrig’s financial trajectory is primarily a product of (1) ALK TKI competitive sequencing and payer contracting, and (2) US exclusivity and Orange Book-driven generic entry timing.
• Patent estate strength and litigation outcomes determine when net sales erosion becomes structurally inevitable.
• Formulation and method-of-use coverage can delay ANDA entry and slow erosion even after core expiry.
• The most material earnings risk for a branded oral oncology TKI is not biologic substitution but faster-than-anticipated payer-driven conversion to low-cost TKIs after generic availability.

FAQs

1. How does Orange Book patent expiration for brigatinib map to ANDA submission eligibility and approval risk?
2. What settlement terms typically control Alunbrig generic launch timing and market share retention?
3. Which payer contracting levers most affect net price and uptake of generic brigatinib after launch?
4. How do CNS-focused efficacy claims influence prescribing behavior and persistence on Alunbrig versus alternate ALK TKIs?
5. What manufacturing and formulation equivalency hurdles most often delay generic oral oncology TKIs like brigatinib?

References

No sources were cited because no Orange Book, FDA labeling, patent, litigation, or financial performance dataset was provided in the prompt.

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