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 thirty-eight 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:	138
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	49
Clinical Trials:	22
Patent Applications:	88
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 Birmingham	Phase 2/Phase 3
Cancer Research UK	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

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

Russian Federation

Singapore

South Africa

South Korea

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
Taiwan	I531367
Norway	2975024
New Zealand	597477	Tetracyclic compounds
Mexico	2021012300	FORMULACION QUE CONTIENE UNA GRAN CANTIDAD DE COMPUESTO TETRACICLICO. (PREPARATION CONTAINING TETRACYCLIC COMPOUND AT HIGH DOSE.)

Supplementary Protection Certificates for ALECENSA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2441753	LUC00022	Luxembourg		PRODUCT NAME: ALECTINIB OU SEL OU SOLVATE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/16/1169/001 20170220
2441753	PA2017017	Lithuania		PRODUCT NAME: ALEKTINIBAS ARBA JO DRUSKA, ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/16/1169 20170216
2441753	300876	Netherlands		PRODUCT NAME: ALECTINIB DAN WEL EEN ZOUT OF SOLVAAT DAARVAN; REGISTRATION NO/DATE: EU/1/16/1169/001 20170220
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

Market Dynamics and Financial Trajectory for Alecensa

Introduction to Alecensa

Alecensa, developed by Roche, is an oral anaplastic lymphoma kinase (ALK) inhibitor used in the treatment of ALK-positive non-small cell lung cancer (NSCLC). The drug has undergone significant developments and approvals, shaping its market dynamics and financial trajectory.

Approval History and Clinical Significance

Alecensa was initially approved by the FDA in December 2015 as a second-line treatment for metastatic ALK-positive NSCLC, following Pfizer's Xalkori (crizotinib)[1][3][4].

• In 2017, Alecensa received approval as a first-line therapy for ALK-positive NSCLC, demonstrating superior efficacy compared to Xalkori in reducing the risk of disease progression[3].
• Recently, on April 18, 2024, the FDA approved Alecensa as an adjuvant therapy for completely resected ALK-positive NSCLC patients, based on the Phase III ALINA trial. This approval marks Alecensa as the first-ever adjuvant therapy for this patient group, significantly reducing the risk of recurrence or death by 76% compared to platinum-based chemotherapy[1][4].

Clinical Trials and Efficacy

The Phase III ALINA trial, which led to the latest approval, enrolled 257 patients with stage IB–IIIA ALK-positive NSCLC. The trial showed that Alecensa improved the disease-free survival (DFS) rate to 93.8% at 24 months, compared to 63% in the control group[1][4].

Market Competition

Alecensa operates in a competitive landscape with other ALK inhibitors such as Pfizer's Xalkori and Lorbrena, and Novartis's Zykadia.

• Xalkori: Alecensa has consistently shown superior efficacy over Xalkori in first-line treatments, particularly in reducing the risk of disease progression[3].
• Lorbrena: While Lorbrena is a next-generation ALK/ROS1 inhibitor, Alecensa's recent approval as an adjuvant therapy gives it a competitive edge, as Lorbrena lacks ongoing label expansion trials in adjuvant settings[1].
• Zykadia: Novartis's Zykadia is also vying for market share, but analysts suggest Alecensa's study design and efficacy data position it favorably against Zykadia[3].

Financial Performance and Projections

Alecensa has been a significant contributor to Roche's financial performance.

• Sales: In 2023, Alecensa generated approximately 1.5 billion Swiss francs ($1.65 billion) in sales, making it the top-selling drug in the ALK inhibitor class[4].
• Global Sales Projections: According to GlobalData, Alecensa is projected to generate $2.2 billion in global sales by 2029, outpacing its nearest competitor, Lorbrena, which is expected to achieve $854 million in sales by the same year[1].

Market Growth and Epidemiology

The demand for Alecensa is driven by the growing number of ALK-positive NSCLC cases.

• Epidemiology: The anticipated number of ALK-positive NSCLC cases in the eight major markets (China, France, Germany, Italy, Japan, Spain, the UK, and the US) is expected to reach 76,887 cases by 2029[1].
• Market Expansion: Roche is exploring Alecensa’s potential as an adjuvant therapy following chemoradiation for unresectable, locally advanced, stage III NSCLC patients with an ALK gene fusion/rearrangement through the Phase III HORIZON-01 clinical trial. A successful outcome could significantly broaden Alecensa’s global market reach[1].

Impact on Roche’s Financials

Alecensa’s success has positively impacted Roche’s overall financial performance.

• Pharmaceuticals Division: The growing demand for Alecensa, along with other key drugs like Vabysmo, Ocrevus, and Hemlibra, has driven sales in the Pharmaceuticals Division. In 2023, this division saw sales of CHF 44.6 billion, an increase of 6% at constant exchange rates (CER)[2].
• Net Income and Operating Profit: While Roche’s net income and operating profit have been influenced by various factors including restructuring costs and intangible asset impairments, the consistent performance of Alecensa has been a stabilizing factor[2][5].

Future Outlook and Potential

The future outlook for Alecensa is promising, with ongoing trials and expanding indications.

• Ongoing Trials: The Phase III HORIZON-01 clinical trial could expand Alecensa’s use to unresectable, locally advanced NSCLC patients, further increasing its market reach[1].
• Biomarker Testing: The importance of testing for ALK and other relevant biomarkers is now more crucial than ever, ensuring that patients receive the most appropriate treatment. This could drive increased adoption of Alecensa in early-stage lung cancer patients[1].

Key Takeaways

• Alecensa has received FDA approval as an adjuvant therapy for completely resected ALK-positive NSCLC patients.
• The drug has shown superior efficacy over competitors like Xalkori and Lorbrena.
• Projected global sales of $2.2 billion by 2029 highlight its financial potential.
• Ongoing trials and expanding indications could further broaden its market reach.
• The growing need for effective treatments in ALK-positive NSCLC drives its market demand.

FAQs

What is Alecensa used for?

Alecensa is used as an oral anaplastic lymphoma kinase (ALK) inhibitor for the treatment of ALK-positive non-small cell lung cancer (NSCLC).

What are the recent approvals for Alecensa?

Alecensa was recently approved by the FDA as an adjuvant therapy for completely resected ALK-positive NSCLC patients, following the Phase III ALINA trial.

How does Alecensa compare to other ALK inhibitors?

Alecensa has shown superior efficacy over Pfizer's Xalkori and Novartis's Zykadia in various clinical trials, and it has a competitive edge over Lorbrena due to its recent adjuvant therapy approval.

What are the financial projections for Alecensa?

Alecensa is projected to generate $2.2 billion in global sales by 2029, according to GlobalData.

What are the ongoing clinical trials for Alecensa?

Roche is currently conducting the Phase III HORIZON-01 clinical trial to explore Alecensa’s potential as an adjuvant therapy following chemoradiation for unresectable, locally advanced, stage III NSCLC patients with an ALK gene fusion/rearrangement.

Cited Sources

1. Clinical Trials Arena: FDA approves Alecensa as therapy for ALK-positive lung cancer[1].
2. Roche Finance Report 2023: IFRS net income and core earnings per share[2].
3. FiercePharma: Roche's Alecensa poised for first-line market battle[3].
4. FiercePharma: Roche's Alecensa snags FDA postsurgery nod in lung cancer[4].
5. Roche Finance Report 2022: IFRS operating profit and net income[5].

Last updated: 2024-12-16