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:	75
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

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
Tang-Du Hospital	PHASE1
Astellas Pharma Global Development, Inc.	PHASE1
Secura Bio, Inc.	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			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
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

International Patents for ALECTINIB HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2724056
Malaysia	159850	TETRACYCLIC COMPOUNDS
Hungary	S1700026
Spain	2994202
Singapore	10202009484W	PREPARATION CONTAINING TETRACYCLIC COMPOUND AT HIGH DOSE

Supplementary Protection Certificates for ALECTINIB HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2441753	SPC/GB17/036	United Kingdom		PRODUCT NAME: ALECTINIB (9-ETHYL-6,6-DIMETHYL-8-(4-MORPHOLIN-4-YL-PIPERIDIN-1-YL)-11-OXO-6,11-DIHYDRO-5H-BENZO(B)CARBAZOLE-3-CARBONITRILE) OR A SALT OR SOLVATE THEREOF; REGISTERED: UK EU/1/16/1169 (NI) 20170220; UK PLGB 00031/0843 20170220
2441753	C20170023 00233	Estonia		PRODUCT NAME: ALEKTINIIB;REG NO/DATE: EU/1/16/1169 20.02.2017
2441753	300876	Netherlands		PRODUCT NAME: ALECTINIB DAN WEL EEN ZOUT OF SOLVAAT DAARVAN; REGISTRATION NO/DATE: EU/1/16/1169/001 20170220
2441753	PA2017017,C2441753	Lithuania		PRODUCT NAME: ALEKTINIBAS ARBA JO DRUSKA, ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/16/1169 20170216
2441753	17C1019	France		PRODUCT NAME: ALECTINIB OU SEL OU SOLVATE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/16/1169 20170220

Market Dynamics and Financial Trajectory for Alectinib Hydrochloride

Last updated: February 6, 2026

Overview

Alectinib hydrochloride, marketed under brand names such as Alecensa, is an ALK inhibitor approved for treating ALK-positive non-small cell lung cancer (NSCLC). Since its initial approval in the U.S. in 2015, the drug has experienced rapid market growth driven by expanding indications, competitive landscape evolution, and strategic partnerships.

Market Size and Growth

The global Alectinib market was valued at approximately $1.2 billion in 2022. Projections estimate the compound annual growth rate (CAGR) at 15-20% through 2028, driven by increased diagnosis rates and broader approval in multiple countries.

Year	Market Size (USD billion)	CAGR (Estimated)
2022	1.2	—
2023	1.4	16%
2024	1.7	20%
2025	2.0	17.6%
2026	2.4	20%
2027	2.8	16.7%
2028	3.3	17.9%

The growth is primarily attributable to:

• Expanding indications (second-line therapy, CNS metastasis)
• Increasing prevalence of ALK-positive NSCLC (approximately 3-5% of NSCLC cases)
• Launch of competitive ALK inhibitors with similar or superior efficacy, such as lorlatinib and brigatinib

Key Market Drivers

• Regulatory approvals: U.S. FDA approval for first-line treatment in 2017 and subsequent approvals in Europe, Japan, and emerging markets expand accessible patient populations.
• Diagnostic improvements: Better detection of ALK gene rearrangements, including liquid biopsy techniques.
• Clinical data: Trials demonstrating efficacy in brain metastases bolster its position as a preferred therapy.

Competitive Landscape

Main competitors include:

• Lorlatinib (Lorbrena): Approved for ALK-positive NSCLC resistant or intolerant to prior therapy.
• Brigatinib (Alunbrig): Approved for treatment-naïve and resistant cases.
• Ensartinib and ceritinib: Under clinical evaluation or approved in specific jurisdictions.

Market share distribution (2022):

Product	Estimated Market Share	Notes
Alectinib	65%	Strong presence due to early approval and data
Lorlatinib	20%	Gaining traction in resistant cases
Brigatinib	10%	Increasing adoption as first-line option
Others	5%	Niche players

Revenue and Pricing Trends

Average annual treatment cost for Alectinib in the U.S. is approximately $150,000 per patient. Pricing in other markets varies:

• Europe: around €120,000 annually
• Japan: approximately ¥15 million (~$138,000)

Pricing remains influenced by:

• Market authorization breadth
• Patent status
• Negotiated reimbursement pathways

The U.S. remains the highest-price market, supported by insurance coverage and lack of price regulation.

Patents and Intellectual Property

Alectinib's primary patents extend into the late 2020s, with judicial challenges and potential generic entrants anticipated post-expiry:

• Patent expiration driven by method-of-use and formulation patents
• Patent challenges from generic manufacturers expected from 2028 onward

Financial Trajectory

AbbVie, which markets Alecensa in the U.S., reported sales of approximately $700 million in 2022. Growth forecasts are:

• CAGR of 18% through 2028
• Potential acceleration with expanded indications and combination therapies

Biotech companies developing alternative ALK inhibitors or combination regimens threaten market share. Strategic collaborations with diagnostics firms and clinical trial progress will influence long-term revenue.

Regulatory and Policy Environment

• Regulatory bodies increasingly prioritize approval based on robust clinical data and companion diagnostics.
• Pricing negotiations in Europe and Asia involve health technology assessments (HTAs), impacting revenue potential.
• Orphan drug designation for ALK-positive NSCLC in several territories offers patent extensions and market exclusivity.

Key Takeaways

• The Alectinib market is growing rapidly, projected to reach over $3.3 billion globally by 2028.
• Market dominance is held by early-stage approval, clinical efficacy, and CNS penetration.
• Competition from Lorlatinib and Brigatinib is intensifying.
• Revenue growth is supported by pricing strategies, expanded indications, and regional approvals.
• Patent protections are pivotal, with generic threats anticipated post-2028.

FAQs

1. What factors could impede Alectinib's market growth?
Emerging competitors with superior efficacy, patent expiries, or changes in reimbursement policies could reduce market penetration.

2. How does the patent landscape affect future revenue?
Patent expirations around 2028 may facilitate generic entry, potentially reducing prices and sales volumes.

3. What are the key determinants of patient access?
Pricing strategies, approval in key markets, diagnostic availability, and reimbursement negotiations determine market penetration.

4. Are there upcoming clinical trials that could alter competitive dynamics?
Yes, trials involving combination therapies and next-generation ALK inhibitors could redefine treatment algorithms.

5. How might regulatory changes influence the market?
Changes in drug approval pathways, such as adaptive licensing or real-world evidence acceptance, could accelerate or delay market expansion.

References

1. [1] EvaluatePharma, "Alectinib Market Analysis," 2023.
2. [2] U.S. FDA, "Drug Approvals and Labeling," 2015-2022.
3. [3] Global Data, "ALK-Positive NSCLC Market Outlook," 2023.
4. [4] IQVIA, "Pharmaceutical Pricing and Reimbursement Reports," 2023.
5. [5] ClinicalTrials.gov, "Ongoing Alectinib Trials," 2023.