ALECENSA Drug Patent Profile

When do Alecensa patents expire, and when can generic versions of Alecensa launch?

Alecensa is a drug marketed by Hoffmann-la Roche and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and forty-three patent family members in thirty-nine countries.

The generic ingredient in ALECENSA is alectinib hydrochloride. One supplier is listed for this compound. Additional details are available on the alectinib hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Alecensa

Alecensa was eligible for patent challenges on December 11, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 24, 2035. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for ALECENSA

International Patents:	143
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	61
Clinical Trials:	23
Patent Applications:	505
Drug Prices:	Drug price information for ALECENSA
What excipients (inactive ingredients) are in ALECENSA?	ALECENSA excipients list
DailyMed Link:	ALECENSA at DailyMed

See drug prices for ALECENSA

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

NDA:

208434

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 ALECENSA

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

Sponsor	Phase
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair	Phase 2/Phase 3
University of Manchester	Phase 2/Phase 3
Hoffmann-La Roche	Phase 2/Phase 3

See all ALECENSA clinical trials

Pharmacology for ALECENSA

Drug Class	Kinase Inhibitor
Mechanism of Action	Kinase Inhibitors

Paragraph IV (Patent) Challenges for ALECENSA

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 ALECENSA

ALECENSA is protected by five US patents and two FDA Regulatory Exclusivities.

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
Hoffmann-la Roche	ALECENSA	alectinib hydrochloride	CAPSULE;ORAL	208434-001	Dec 11, 2015		RX	Yes	Yes			Y
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			Y
Hoffmann-la Roche	ALECENSA	alectinib hydrochloride	CAPSULE;ORAL	208434-001	Dec 11, 2015		RX	Yes	Yes			Y
Hoffmann-la Roche	ALECENSA	alectinib hydrochloride	CAPSULE;ORAL	208434-001	Dec 11, 2015		RX	Yes	Yes				Y
Hoffmann-la Roche	ALECENSA	alectinib hydrochloride	CAPSULE;ORAL	208434-001	Dec 11, 2015		RX	Yes	Yes

International Patents for ALECENSA

When does loss-of-exclusivity occur for ALECENSA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

European Patent Office

Israel

Japan

Malaysia

Mexico

New Zealand

Poland

Russian Federation

Singapore

South Africa

South Korea

Spain

Taiwan

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 ALECENSA around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	2994202
New Zealand	597477	Tetracyclic compounds
Russian Federation	2020119391	ПОЛУЧЕНИЕ ТЕТРАЦИКЛИЧЕСКОГО СОЕДИНЕНИЯ, СОДЕРЖАЩЕГОСЯ В ВЫСОКОЙ ДОЗЕ
European Patent Office	4397659	PRÉPARATION CONTENANT UN COMPOSÉ TÉTRACYCLIQUE À DOSE ÉLEVÉE (PREPARATION CONTAINING TETRACYCLIC COMPOUND AT HIGH DOSE)
Luxembourg	C00022
Cyprus	1117752

Supplementary Protection Certificates for ALECENSA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2441753	17C1019	France		PRODUCT NAME: ALECTINIB OU SEL OU SOLVATE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/16/1169 20170220
2441753	2017/026	Ireland		PRODUCT NAME: ALECTINIB OR SALT OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/16/1169/001 20170216
2441753	122017000048	Germany		PRODUCT NAME: ALECTINIB ODER EIN SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/16/1169 20170216
2441753	31/2017	Austria		PRODUCT NAME: ALECTINIB ODER DESSEN SALZE ODER DESSEN SOLVATE; REGISTRATION NO/DATE: EU/1/16/1169 20170220
2441753	300876	Netherlands		PRODUCT NAME: ALECTINIB DAN WEL EEN ZOUT OF SOLVAAT DAARVAN; REGISTRATION NO/DATE: EU/1/16/1169/001 20170220
2441753	C02441753/01	Switzerland		PRODUCT NAME: ALECTINIBUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65970 26.01.2017

Market Dynamics and Financial Trajectory for ALECENSA (Alectinib)

Last updated: November 26, 2025

Introduction

Alectinib (brand name ALECENSA) is a highly selective ALK (anaplastic lymphoma kinase) inhibitor developed by Genentech (a Roche subsidiary) for the treatment of non-small cell lung cancer (NSCLC). Since its regulatory approval, ALECENSA has emerged as a critical player in targeted oncology, driven by evolving market dynamics and a robust financial trajectory. This analysis explores the factors shaping ALECENSA’s market landscape and projects its economic potential within the broader pharmaceutical ecosystem.

Market Landscape and Competitive Positioning

Growing Incidence of ALK-Positive NSCLC

Non-small cell lung cancer accounts for approximately 85% of lung cancer diagnoses globally, with ALK gene rearrangements occurring in roughly 3-5% of NSCLC cases [1]. The rising incidence of lung cancer, especially in aging populations and regions with high tobacco usage, expands the potential target population for ALK inhibitors like ALECENSA.

Paradigm Shift Toward Targeted Therapies

The therapeutic landscape for NSCLC has shifted from traditional chemotherapy to precision medicine. ALK inhibitors represent a cornerstone of this shift, offering improved efficacy and tolerability. Notably, ALECENSA’s favorable CNS penetration addresses one of the primary limitations of earlier agents such as crizotinib, which demonstrated limited activity against brain metastases [2].

Competitive Environment

The ALK inhibitor market features key competitors such as crizotinib, brigatinib, lorlatinib, and repotrectinib. While crizotinib was the first approved ALK inhibitor, subsequent drugs have competed on efficacy, CNS activity, and resistance profiles. ALECENSA's distinct advantages, including PFS (progression-free survival) benefits and CNS activity, position it favorably. However, aggressive rivalry necessitates continuous innovation and marketing efforts to sustain market share.

Regulatory Approvals and Global Expansion

Approved Indications

Since its FDA approval in 2017 for ALK-positive metastatic NSCLC, ALECENSA has broadened its indications. The drug is approved as a first-line therapy and for patients resistant to prior treatments [3]. Regulatory bodies such as the EMA (European Medicines Agency) have followed suit, expanding its accessibility worldwide.

Market Expansion Strategies

Genentech’s strategic focus on expanding the global footprint includes navigating regulatory pathways across Asia-Pacific, Latin America, and emerging markets. Pricing strategies and managed-access agreements are pivotal in regions with constrained healthcare budgets.

Revenue Drivers and Financial Trajectory

Sales Performance

According to Roche’s fiscal disclosures, ALECENSA recorded global sales of approximately CHF 2.7 billion in 2022, reflecting year-over-year growth driven by increased adoption in first-line settings and expanding indications [4]. The drug’s revenue growth is compounded by broader access and adoption in high-incidence markets.

Key Revenue Influencers

• Line of Therapy Expansion: As a front-line treatment, ALECENSA’s sales are expected to surge, supported by improved clinical trial outcomes demonstrating superior PFS compared to earlier agents.
• Market Penetration: Increased usage in Asia, Latin America, and Europe due to approvals and local clinical guidelines.
• Resistance and Combination Strategies: Developing resistance to ALK inhibitors challenges sustained sales; however, combination therapies and next-generation agents could offset these issues.

Cost and Pricing Dynamics

ALECENSA commands premium pricing aligned with targeted therapies, supported by market exclusivity, clinical efficacy, and CNS activity. Patents extending over the next decade, along with regulatory exclusivities, sustain these price points |[5]|. Nonetheless, price erosion due to biosimilarity and generic competition remains a future consideration.

Future Potential and Strategic Outlook

Innovation and Pipeline Developments

Genentech continues to invest in next-generation ALK inhibitors and combination therapies to extend the therapeutic lifecycle of ALECENSA. Ongoing clinical trials assess efficacy in overcoming resistance and CNS metastasis, which could fuel further market expansion.

Market Penetration Amid Global Health Dynamics

Growing acceptance and incorporation into treatment algorithms, especially with evidence from trials like ALEX (which demonstrated superior outcomes over crizotinib), strengthen ALECENSA’s position. Additionally, the increasing prevalence of NSCLC coupled with improved testing for ALK mutations supports future sales.

Impact of Healthcare Policy and Pricing

Policy shifts toward value-based care and price negotiations, notably in major markets like the US and EU, could influence revenue trajectories. Price-volume relationships will be critical, especially as biosimilar competitors emerge.

Challenges and Risks

• Resistance Development: Durability of responses remains a concern, with emerging resistance necessitating ongoing research.
• Market Competition: Branded competitors and potential generics post-patent expiry threaten long-term revenue streams.
• Regulatory and Reimbursement Landscape: Policy changes and payer negotiations are unpredictable factors influencing sales.

Conclusion

The market dynamics for ALECENSA showcase a robust growth pattern driven by increasing NSCLC incidence, targeted therapy adoption, and expanding indications. Financially, ALECENSA is positioned as a lucrative asset within Roche’s oncology portfolio, with revenues expected to grow supported by global expansion and clinical advancements. However, sustaining this trajectory demands ongoing innovation, strategic market access efforts, and vigilant management of competitive and regulatory challenges.

Key Takeaways

• Market Potential: The global ALK-positive NSCLC market is projected to reach over US$4 billion by 2027, with ALECENSA capturing a significant share due to its clinical advantages [6].
• Revenue Growth Drivers: Increased first-line adoption, geographic expansion, and clinical trial successes underpin sales growth.
• Competitive Edge: Superior CNS activity and favorable safety profile position ALECENSA ahead of older ALK inhibitors.
• Future Outlook: Ongoing pipeline development and combination strategies are essential to extend market relevance and address resistance.
• Market Risks: Patent expiration, biosimilar entry, and policy changes require strategic navigation to sustain financial performance.

FAQs

1. What distinguishes ALECENSA from other ALK inhibitors?
ALECENSA’s primary advantage is its potent activity against ALK mutations and excellent CNS penetration, which addresses brain metastases more effectively than earlier agents like crizotinib.

2. How is ALECENSA positioned in the treatment guidelines for NSCLC?
It is recommended as a first-line therapy for ALK-positive NSCLC due to its superior progression-free survival and CNS efficacy, supported by clinical trial data such as the ALEX study.

3. What are the main risks to ALECENSA’s market dominance?
Emerging resistance, development of next-generation inhibitors, patent expirations, and biosimilar competition pose significant challenges.

4. How does global healthcare policy impact ALECENSA’s sales?
Pricing negotiations, reimbursement policies, and access programs influence market penetration, especially in cost-sensitive regions.

5. What opportunities exist for future growth of ALECENSA?
Expanding indications, combination therapies targeting resistance pathways, and entering emerging markets offer avenues for growth.

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References

[1] Saito, M., et al. (2019). "Global Epidemiology of ALK-Positive NSCLC." Lung Cancer Journal.
[2] Shaw, A. T., et al. (2016). "Selctive ALK inhibitors for NSCLC with CNS activity." Nature Reviews Clinical Oncology.
[3] FDA Label, ALECENSA (Alectinib). (2017).
[4] Roche FY2022 Financial Report.
[5] IQVIA. (2022). "Pricing and Market Trends for Oncology Drugs."
[6] Market Research Future. (2022). "ALK Inhibitors Market Analysis."