Alectinib hydrochloride - Generic Drug Details

What are the generic sources for alectinib hydrochloride and what is the scope of patent protection?

Alectinib hydrochloride is the generic ingredient in one branded drug marketed by Hoffmann-la Roche and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Alectinib hydrochloride has one hundred and forty-three patent family members in thirty-nine countries.

One supplier is listed for this compound.

Summary for alectinib hydrochloride

International Patents:	143
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	49
Clinical Trials:	74
What excipients (inactive ingredients) are in alectinib hydrochloride?	alectinib hydrochloride excipients list
DailyMed Link:	alectinib hydrochloride at DailyMed

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

Constraining patent/regulatory exclusivity:

10,350,214

Dosage:

CAPSULE;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 alectinib hydrochloride

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

Sponsor	Phase
Astellas Pharma Global Development, Inc.	PHASE1
Genentech, Inc.	PHASE1
Memorial Sloan Kettering Cancer Center	PHASE1

See all alectinib hydrochloride clinical trials

Pharmacology for alectinib hydrochloride

Drug Class	Kinase Inhibitor
Mechanism of Action	Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for alectinib hydrochloride

L01ED	Anaplastic lymphoma kinase (ALK) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for ALECTINIB HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ALECENSA	Capsules	alectinib hydrochloride	150 mg	208434	1	2019-12-11

US Patents and Regulatory Information for alectinib hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hoffmann-la Roche	ALECENSA	alectinib hydrochloride	CAPSULE;ORAL	208434-001	Dec 11, 2015		RX	Yes	Yes
Hoffmann-la Roche	ALECENSA	alectinib hydrochloride	CAPSULE;ORAL	208434-001	Dec 11, 2015		RX	Yes	Yes	11,433,076		Y
Hoffmann-la Roche	ALECENSA	alectinib hydrochloride	CAPSULE;ORAL	208434-001	Dec 11, 2015		RX	Yes	Yes	9,126,931			Y
Hoffmann-la Roche	ALECENSA	alectinib hydrochloride	CAPSULE;ORAL	208434-001	Dec 11, 2015		RX	Yes	Yes	10,350,214		Y
Hoffmann-la Roche	ALECENSA	alectinib hydrochloride	CAPSULE;ORAL	208434-001	Dec 11, 2015		RX	Yes	Yes	9,440,922		Y

International Patents for alectinib hydrochloride

Country	Patent Number	Title	Estimated Expiration
Spain	2668775
Taiwan	I720943
Japan	WO2012023597	４環性化合物を含む組成物
Hungary	E039167
European Patent Office	3613729	COMPOSÉS TÉTRACYCLIQUES (TETRACYCLIC COMPOUNDS)

Supplementary Protection Certificates for alectinib hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2441753	1790024-2	Sweden		PRODUCT NAME: ALECTINIB OR SALT OR SOLVATE THEREOF; REG. NO/DATE: EU/1/16/1169/001 20170220
2441753	CA 2017 00024	Denmark		PRODUCT NAME: ALECTINIB, ELLER SALT ELLER SOLVAT DERAF; REG. NO/DATE: EU/1/16/1169/01 20170220
2441753	17C1019	France		PRODUCT NAME: ALECTINIB OU SEL OU SOLVATE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/16/1169 20170220
2441753	PA2017017	Lithuania		PRODUCT NAME: ALEKTINIBAS ARBA JO DRUSKA, ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/16/1169 20170216
2441753	PA2017017,C2441753	Lithuania		PRODUCT NAME: ALEKTINIBAS ARBA JO DRUSKA, ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/16/1169 20170216

Market Dynamics and Financial Trajectory for Alectinib Hydrochloride (Alectinib HCl)

Last updated: November 14, 2025

Introduction

Alectinib Hydrochloride, marketed globally as Alecensa among other names, stands at the forefront of targeted therapies for ALK-positive non-small cell lung cancer (NSCLC). Its development, regulatory approval, and commercialization have shaped it into a significant asset within the oncology pharmaceutical landscape. Understanding the market dynamics and financial trajectory of Alectinib HCl offers critical insights into its commercial potential, competitive positioning, and future growth pathways.

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Market Overview

Therapeutic Indication and Market Need

Non-small cell lung cancer (NSCLC) accounts for approximately 85% of lung cancer cases globally. Subsets of NSCLC patients harbor ALK gene rearrangements, making them candidates for targeted therapy with ALK inhibitors. Before Alectinib’s advent, Crizotinib was the standard first-line ALK inhibitor, but resistance development and CNS metastases posed significant challenges.

Alectinib's superior CNS penetration and efficacy against resistance mutations have positioned it as a preferred first-line agent, a key driving force behind its market expansion. As of 2023, the increasing adoption of Alectinib in clinical practice underscores a robust demand trajectory, particularly in high-incidence regions like North America, Europe, and parts of Asia.

Market Size and Growth

The global ALK-positive NSCLC treatment market was valued at approximately USD 1.2 billion in 2022, with projections reaching USD 2.0 billion by 2030, reflecting a CAGR of roughly 6% (industry estimates). The rise is attributable to:

• Increased diagnosis through advanced biomarker testing.
• Regulatory approvals expanding indications.
• A shift from chemotherapy to targeted therapies.
• Rising awareness and screening initiatives.

Competitive Landscape

Alectinib faces competition primarily from Crizotinib, Ceritinib, Brigatinib, and Lorlatinib. However, clinical trials, notably the ALEX study, demonstrated that Alectinib significantly surpasses Crizotinib in progression-free survival (PFS) and CNS efficacy, consolidating its market dominance in the first-line setting (source: [1]).

Other competitors are working on next-generation ALK inhibitors or combination therapies, which may influence future market shares. Nonetheless, Alectinib's validated efficacy and safety profile sustain its competitive edge.

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Market Dynamics Influencing Alectinib HCl

Regulatory Approvals and Geographic Expansion

Regulatory milestones directly impact market access:

• FDA (2015): Approved for metastatic ALK-positive NSCLC after progression on Crizotinib.
• EMA (2017): Approved for similar indications in Europe.
• Japan (2017): Approved earlier, reflecting proactive access in Asian markets.
• Additional markets: Rapid approval in emerging economies facilitated increased sales volume.

These approvals catalyzed geographic expansion and sales growth. Moreover, expanding indications—such as adjuvant settings or earlier lines—could further buoy revenue streams.

Clinical Efficacy and Safety Profile

Alectinib's attractiveness stems from its:

• Superior CNS activity, addressing CNS metastases prevalent in ALK-positive NSCLC.
• Favourable side-effect profile compared with first-generation inhibitors.
• Efficacy in combating resistance mutations, extending treatment durability.

These factors have translated into clinician preference, influencing prescribing trends and reimbursement policies.

Pricing, Reimbursement, and Market Penetration

Pricing strategies vary by region, often reflecting healthcare systems and reimbursement landscapes. Premium positioning in developed markets, combined with broader access programs in emerging economies, affects revenue distribution.

Reimbursement policies favoring targeted therapies due to improved patient outcomes expedite uptake. However, high drug costs and biosimilar entry post-patent expiry pose ongoing challenges to profit margins.

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Financial Trajectory

Revenue Trends

Since its approval, Alectinib’s global sales have demonstrated consistent growth:

• 2018: Estimated USD 600 million globally.
• 2022: Exceeded USD 1.4 billion, with steady annual increase (~20% CAGR in recent years).
• 2025 projections: Expected to surpass USD 2 billion, contingent on market expansion and indication approvals.

Driving Factors

Key revenue drivers include:

• Launch in additional markets.
• Expansion of first-line treatment use based on ongoing clinical data.
• Increased diagnostic testing leading to higher patient identification.
• Competitive differentiation based on CNS efficacy.

Challenges and Market Risks

Potential risks include:

• Price erosion due to biosimilar or generic ALK inhibitors upon patent expiry.
• Competition from emerging ALK inhibitors with potentially better profiles.
• Regulatory delays or restrictions in certain jurisdictions.
• Market saturation in mature regions.

Research and Development Investments

Pharmaceutical companies continuously invest in clinical trials exploring combination therapies, resistance mechanisms, and new indications. These investments aim to sustain Alectinib’s leadership position and open new revenue streams.

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Emerging Market Opportunities

Combination Therapies

Clinical trials investigate combining Alectinib with immune checkpoint inhibitors or other targeted agents to improve response durability. Success could expand its therapeutic reach.

Biomarker-Driven Personalized Medicine

Advancements in diagnostic tools promise tailored treatments, increasing Alectinib’s adoption in precision medicine protocols.

Geographical Expansion

Growing diagnostics capabilities and healthcare infrastructure in Asia, Latin America, and Africa offer significant expansion opportunities, contingent on regulatory approvals and market access strategies.

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Conclusion

Alectinib Hydrochloride has established itself as a cornerstone in the treatment of ALK-positive NSCLC, with a compelling clinical profile driving strong market demand. Its financial performance reflects steady growth, buoyed by first-line approval, expanding indications, and geographic penetration. While competitive pressures and patent expirations pose challenges, ongoing R&D and strategic market expansion are poised to sustain its trajectory.

Stakeholders—pharmaceutical companies, investors, and healthcare providers—must monitor regulatory developments, clinical advancements, and competitive landscapes to optimize their positioning within this evolving market.

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Key Takeaways

• Market Leadership: Alectinib’s superior CNS penetration and efficacy position it as the preferred first-line ALK inhibitor, fostering consistent revenue growth.
• Growth Drivers: Expanded indications, geographic penetration, and advances in diagnostics underpin the positive financial trajectory.
• Competitive Risks: Biosimilar entry, emerging competitors, and potential resistance development necessitate strategic planning.
• Market Opportunities: Combination therapies and personalized medicine approaches could unlock new revenue streams.
• Strategic Focus: Continuous R&D, clinical trial leadership, and regulatory engagement are vital to maintaining market dominance.

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FAQs

1. How has Alectinib’s market share evolved since its initial approval?
Since its approval in 2015, Alectinib’s market share has grown significantly, driven by clinical superiority over earlier ALK inhibitors and expanded indications. By 2022, it commands over 60% of the ALK-positive NSCLC treatment market in many regions, with ongoing gains due to first-line adoption.

2. What are the primary factors impacting Alectinib’s revenue growth?
Key factors include geographic expansion, increased uptake as a first-line therapy, approval in new markets, reimbursement policies, and clinician preference due to its efficacy and safety profile.

3. What upcoming developments could influence Alectinib’s financial trajectory?
Potential developments include new indication approvals (e.g., adjuvant therapy), combination treatment trials, biosimilar entries post-patent expiration, and innovations in diagnostic testing that enable earlier detection and treatment.

4. How does competition impact Alectinib’s market?
While Alectinib currently holds a leading position, rivals like Brigatinib and Lorlatinib continue to evolve, potentially offering alternative mechanisms or improved profiles. Market share could shift with breakthrough data or regulatory success for competitors.

5. What are the strategic implications for stakeholders in the Alectinib market?
Stakeholders should prioritize ongoing clinical research, expand into emerging markets, manage patent portfolios effectively, and explore combination therapies to sustain growth amid increasing competition.

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Sources
[1] Shaw, A.T., et al. (2018). Alectinib versus Crizotinib in ALK-Positive Non-Small-Cell Lung Cancer. The New England Journal of Medicine.