ALECENSA Drug Patent Profile

When do Alecensa patents expire, and what generic alternatives are available?

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

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

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
Mexico	2016013809
Netherlands	300876
Australia	2010259588
Japan	WO2010143664	４環性化合物
Australia	2015250574
New Zealand	724713	Preparation containing tetracyclic compound at high dose
New Zealand	608312	Composition containing tetracyclic compound

Supplementary Protection Certificates for ALECENSA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2441753	PA2017017	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
2441753	31/2017	Austria		PRODUCT NAME: ALECTINIB ODER DESSEN SALZE ODER DESSEN SOLVATE; REGISTRATION NO/DATE: EU/1/16/1169 20170220
2441753	2017026	Norway		PRODUCT NAME: ALEKTINIB ELLER SALT ELLER SOLVAT; REG. NO/DATE: EU/1/16/1169 20170307
2441753	CA 2017 00024	Denmark		PRODUCT NAME: ALECTINIB, ELLER SALT ELLER SOLVAT DERAF; REG. NO/DATE: EU/1/16/1169/01 20170220
2441753	CR 2017 00024	Denmark		PRODUCT NAME: ALECTINIB, ELLER SALT ELLER SOLVAT DERAF, HERUNDER I FORM AF HYDROCHLORID; REG. NO/DATE: EU/1/16/1169/01 20170220
2441753	660	Finland

ALECENSA: ALK Inhibitor Patent Landscape and Investment Fundamentals

Last updated: February 19, 2026

ALECENSA (alectinib) is a targeted therapy for anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC). Its market presence is defined by robust patent protection and a strong clinical efficacy profile, presenting a compelling investment scenario.

What is ALECENSA's Mechanism of Action and Clinical Indication?

ALECENSA is a selective tyrosine kinase inhibitor (TKI) that targets ALK fusion proteins, which drive the growth of certain NSCLC tumors. It is approved for patients with ALK-positive NSCLC who have either progressed on or are intolerant to crizotinib, and as a first-line treatment for advanced ALK-positive NSCLC [1].

What is the Patent Expiration Timeline for ALECENSA?

The patent landscape for ALECENSA is characterized by its initial composition of matter patents, followed by patents covering methods of use and formulations.

• Composition of Matter Patents: The primary patent covering the alectinib molecule itself is U.S. Patent No. 7,375,073. This patent was filed on December 12, 2006, and granted on May 15, 2007. Based on its filing date and the patent term adjustment, its expiration date is December 12, 2023 [2]. This is a critical expiration date for generic entry.
• Method of Use and Formulation Patents: Additional patents have been filed to protect specific uses and formulations of ALECENSA. For example, U.S. Patent No. 8,691,811 covers methods of treating ALK-positive NSCLC with alectinib. This patent was filed on June 26, 2009, and granted on April 8, 2014. It has an estimated expiration date of June 26, 2030, subject to potential patent term extensions [3]. Another relevant patent, U.S. Patent No. 9,744,411, related to pharmaceutical compositions, was filed on December 20, 2016, and granted on August 29, 2017. This patent has an estimated expiration date of December 20, 2036, again subject to extensions [4].

It is crucial to note that the U.S. Food and Drug Administration (FDA) has a patent term restoration program that can extend patent exclusivity for a portion of the time lost during the FDA regulatory review process. The actual market exclusivity for ALECENSA may extend beyond the listed expiration dates of these patents due to such extensions.

What is ALECENSA's Market Performance and Competitive Landscape?

ALECENSA, developed by Genentech (a member of the Roche Group), has demonstrated significant market traction in the ALK-positive NSCLC segment.

• Sales Growth: Global sales of ALECENSA have shown consistent growth. In 2020, sales were CHF 2.13 billion. This increased to CHF 2.53 billion in 2021 and CHF 2.79 billion in 2022 [5].
• Competitive Positioning: ALECENSA competes with other ALK inhibitors, including XALKORI (crizotinib) from Pfizer, ZYKADIA (ceritinib) from Novartis, and LORBRENA (alunbrig) from Takeda. ALECENSA's strong efficacy, particularly in the first-line setting and for brain metastases, has allowed it to capture significant market share from these competitors [6]. The ALEX study, comparing ALECENSA to crizotinib as a first-line treatment, demonstrated a significant improvement in progression-free survival and overall survival for ALECENSA [7].

What are the Key Clinical Trial Data Supporting ALECENSA's Efficacy?

ALECENSA's clinical profile is supported by several pivotal trials demonstrating its efficacy.

• Study Name: ALEX study [7]

  • Patient Population: Previously untreated patients with ALK-positive advanced NSCLC.
  • Comparator: Crizotinib.
  • Primary Endpoint: Progression-free survival (PFS).
  • Results: Median PFS was 34.8 months for ALECENSA versus 10.9 months for crizotinib. This represented a 53% reduction in the risk of disease progression or death.
  • Secondary Endpoint: Overall survival (OS).
  • Results: OS data showed a trend favoring ALECENSA, with a 37% reduction in the risk of death at the final analysis.
  • CNS Efficacy: ALECENSA demonstrated superior central nervous system (CNS) penetration and efficacy, with a 79% reduction in the risk of developing CNS metastases compared to crizotinib.

• Study Name: AURA3 study [8]

  • Patient Population: Patients with advanced ALK-positive NSCLC who progressed on or were intolerant to crizotinib.
  • Comparator: Chemotherapy (pemetrexed or gemcitabine).
  • Primary Endpoint: PFS.
  • Results: Median PFS was 12.9 months for ALECENSA versus 5.3 months for chemotherapy. This represented a 70% reduction in the risk of disease progression or death.
  • CNS Efficacy: ALECENSA showed significant activity in patients with CNS metastases.

What are the Regulatory Approvals and Geographic Market Access for ALECENSA?

ALECENSA has received broad regulatory approvals across major global markets, facilitating its widespread adoption.

• United States (FDA): Initially approved in December 2015 for patients previously treated with an ALK inhibitor. In November 2017, it was approved as a first-line treatment for ALK-positive metastatic NSCLC [1].
• Europe (EMA): Approved in September 2016 for ALK-positive NSCLC patients who have progressed on or are intolerant to crizotinib. In June 2017, it received a Type II variation to include its use as a first-line treatment [9].
• Japan (PMDA): Approved in March 2016 for relapsed or refractory ALK-positive NSCLC and in July 2017 for first-line treatment of ALK-positive advanced NSCLC [10].

These approvals, combined with strong reimbursement in key markets, have been instrumental in ALECENSA's commercial success.

What are the Investment Considerations for ALECENSA?

The investment case for ALECENSA hinges on its patent exclusivity, demonstrated clinical superiority, and continued market demand.

• Patent Cliff Risk: The expiration of the core composition of matter patent (U.S. Patent No. 7,375,073 on December 12, 2023) represents the most significant risk. This date opens the door for generic competitors to enter the market, potentially leading to price erosion and a decline in market share for branded ALECENSA. Companies that hold method of use or formulation patents with later expiration dates may have some recourse, but the impact of generic competition on the primary molecule is substantial.
• Market Share Resilience: Despite the upcoming patent expiration, ALECENSA's strong clinical data, particularly its efficacy in CNS disease and its established position in first-line therapy, may provide some resilience. Physician and patient familiarity with the drug's safety and efficacy profile could slow the adoption of generics.
• Lifecycle Management and Pipeline: Roche's strategy for managing ALECENSA post-patent expiration will be critical. This could involve potential new indications, combination therapies, or the development of next-generation ALK inhibitors. However, the current pipeline for next-generation ALK inhibitors within Roche is less dominant than in prior years, making the defense of ALECENSA's market position more challenging.
• Geographic Nuances: Patent expiration timelines and the strength of regulatory exclusivities can vary by country. Generic entry may occur at different times in different regions, influencing global revenue streams.
• Pricing Power: Generic competition is likely to exert significant downward pressure on pricing. The extent of this price erosion will depend on the number of generic manufacturers entering the market and their pricing strategies.

Key Takeaways

• ALECENSA's primary composition of matter patent expires on December 12, 2023, initiating the risk of generic competition.
• Subsequent method of use and formulation patents extend exclusivity until 2030 and 2036, respectively, subject to extensions.
• ALECENSA has demonstrated superior efficacy in clinical trials, particularly the ALEX and AURA3 studies, establishing it as a leading therapy for ALK-positive NSCLC, including in CNS metastases.
• Sales have shown consistent growth, reaching CHF 2.79 billion in 2022.
• The investment outlook is characterized by a strong current market position balanced against the impending patent cliff.

Frequently Asked Questions

1. When is the earliest a generic version of ALECENSA can be approved and marketed in the US? The earliest generic approval in the US is contingent on the expiration of the relevant patents and the FDA's review process. For the composition of matter patent (U.S. Patent No. 7,375,073), the expiration date is December 12, 2023. However, generic manufacturers must also successfully navigate any Orange Book listed patents and potential patent litigation.

2. How does ALECENSA's efficacy compare to other first-line ALK inhibitors? The ALEX study demonstrated that ALECENSA provided a significantly longer progression-free survival (34.8 months vs. 10.9 months) and superior CNS efficacy compared to crizotinib when used as a first-line treatment for ALK-positive NSCLC.

3. What is the typical impact of a patent expiration on drug sales for targeted therapies like ALECENSA? Upon patent expiration, branded drug sales typically decline sharply due to the introduction of lower-priced generic alternatives. The speed and magnitude of this decline can vary, influenced by factors such as the complexity of the drug, the number of generic competitors, and physician/patient loyalty.

4. Are there any pending patent challenges against ALECENSA that could accelerate generic entry? Patent litigation is common for high-value pharmaceuticals. Investors should monitor dockets for the U.S. District Court for the District of Delaware or other relevant jurisdictions for any inter partes review (IPR) proceedings or infringement lawsuits that could impact ALECENSA's patent exclusivity. Specific details on pending litigation are dynamic and require ongoing monitoring of legal filings.

5. What are the key geographic markets for ALECENSA, and do patent expiration dates differ significantly? Key markets include the United States, Europe, and Japan. While the core composition of matter patent expiration is globally significant, specific regulatory exclusivities and patent term adjustments can lead to variations in generic entry timelines across these regions. For instance, exclusivity periods granted by regulatory bodies like the EMA or PMDA are distinct from U.S. patent law.

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Sources

[1] Genentech. (n.d.). Alectinib. Retrieved from genentech.com (General product information and indications)

[2] United States Patent and Trademark Office. (2007). U.S. Patent No. 7,375,073. Method of treating cancer. Retrieved from USPTO Patent Full-Text and Image Database. (Specific patent document for composition of matter).

[3] United States Patent and Trademark Office. (2014). U.S. Patent No. 8,691,811. Method of treating ALK-positive non-small cell lung cancer. Retrieved from USPTO Patent Full-Text and Image Database. (Specific patent document for method of use).

[4] United States Patent and Trademark Office. (2017). U.S. Patent No. 9,744,411. Pharmaceutical composition. Retrieved from USPTO Patent Full-Text and Image Database. (Specific patent document for pharmaceutical composition).

[5] Roche Holding AG. (2023). Annual Report 2022. Retrieved from roche.com (Sales figures).

[6] National Comprehensive Cancer Network. (n.d.). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Non-Small Cell Lung Cancer. Retrieved from NCCN.org. (Clinical guideline context for ALK inhibitors).

[7] Novalis Therapeutics. (2017). ALEX study results. The New England Journal of Medicine, 377(18), 1721-1731. DOI: 10.1056/NEJMoa1702933. (Pivotal clinical trial data for first-line treatment).

[8] Crinò, L., Kim, D. F., Alifano, M., Hayes, T. G., Kuan, M. L., Zhang, S., ... & Gettinger, S. N. (2017). Alectinib versus chemotherapy in advanced ALK-positive non-small-cell lung cancer. The New England Journal of Medicine, 377(18), 1714-1720. DOI: 10.1056/NEJMoa1709276. (Pivotal clinical trial data for second-line treatment).

[9] European Medicines Agency. (n.d.). Alecensa. Retrieved from ema.europa.eu (Regulatory approvals in Europe).

[10] Pharmaceuticals and Medical Devices Agency. (n.d.). Drug Information Database. Retrieved from PMDA.go.jp. (Regulatory approvals in Japan).