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 thirty-seven patent family members in thirty-nine countries.

One supplier is listed for this compound.

Summary for alectinib hydrochloride

International Patents:	137
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	49
Clinical Trials:	62
Patent Applications:	69
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
Hunan Province Tumor Hospital	Phase 1/Phase 2
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair	Phase 2/Phase 3
Joshua Palmer	Phase 1/Phase 2

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	9,440,922		Y
Hoffmann-la Roche	ALECENSA	alectinib hydrochloride	CAPSULE;ORAL	208434-001	Dec 11, 2015		RX	Yes	Yes	9,365,514		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
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
Hoffmann-la Roche	ALECENSA	alectinib hydrochloride	CAPSULE;ORAL	208434-001	Dec 11, 2015		RX	Yes	Yes

International Patents for alectinib hydrochloride

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2012023597
Croatia	P20180615
Taiwan	201103537	Four rings compounds
Lithuania	3345903
Morocco	33418	مركب رباعي الحلقات
Chile	2011002433	Compuestos tetraciclicos, inhibidores de alk; composicion farmaceutica que comprende dichos compuestos, utiles en la profilaxis o el tratamiento de cancer, metastasis de cancer, depresion o un trastorno de la funcion cognitiva.
Croatia	P20192022

Supplementary Protection Certificates for alectinib hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2441753	132017000079367	Italy		PRODUCT NAME: ALECTINIB O UN SUO SALE O SOLVATO(ALECENSA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1169, 20170220
2441753	C02441753/01	Switzerland		PRODUCT NAME: ALECTINIBUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65970 26.01.2017
2441753	122017000048	Germany		PRODUCT NAME: ALECTINIB ODER EIN SALZ ODER SOLVAT DAVON; 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
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	300876	Netherlands		PRODUCT NAME: ALECTINIB DAN WEL EEN ZOUT OF SOLVAAT DAARVAN; REGISTRATION NO/DATE: EU/1/16/1169/001 20170220
2441753	LUC00022	Luxembourg		PRODUCT NAME: ALECTINIB OU SEL OU SOLVATE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/16/1169/001 20170220

Alectinib hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Alectinib Hydrochloride

Introduction to Alectinib Hydrochloride

Alectinib hydrochloride, marketed under the brand name ALECENSA, is a second-generation anaplastic lymphoma kinase (ALK) inhibitor used primarily in the treatment of ALK-positive non-small cell lung cancer (NSCLC). This drug has revolutionized the treatment landscape for patients with this specific genetic mutation.

Market Size and Growth Projections

The alectinib drugs market is anticipated to experience significant growth over the coming years. The market size is expected to increase at a CAGR of 3 to 5 percent from its estimated valuation by 2031, driven by the rising number of cancer diagnoses and the increasing awareness of ALK inhibitors[1][4].

Segmentation and Geographical Distribution

The market for alectinib is segmented based on type (56 capsules/bottle, 240 capsules/bottle) and application (hospital, drug store), as well as geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa). This segmentation helps in understanding the diverse market dynamics and regional preferences[1].

Drivers of Market Growth

Several factors are driving the growth of the alectinib market:

• Increasing Incidence of ALK-Positive NSCLC: The growing prevalence of ALK-positive NSCLC, coupled with advancements in diagnostic technologies, is leading to more patients being identified and treated with ALK-targeted therapies[4].
• Advancements in Cancer Treatment: Significant advances in cancer treatment and the increasing emphasis on personalized medicine are boosting the demand for targeted therapies like alectinib[4].
• FDA Approvals and Clinical Trials: Recent FDA approvals, including the approval of alectinib as an adjuvant treatment for early-stage ALK+ NSCLC, and ongoing clinical trials are further propelling the market[5].

Economic Impact and Cost Savings

Alectinib has been shown to have a positive economic impact by reducing healthcare costs associated with brain metastases (BM) in ALK+ NSCLC patients. Studies indicate that alectinib can reduce BM-related costs by preventing or delaying the occurrence of BM compared to first-generation ALK inhibitors like crizotinib. For instance, alectinib was estimated to reduce BM-related costs by $41,434 per patient over a 24-month period[2].

Budget Impact Analysis

Maintaining alectinib at its current market share for first-line treatment of ALK+ advanced NSCLC has been shown to result in cost savings. A study using a Markov model estimated that maintaining alectinib's current market share could save $20,570 over a 3-year period, driven by lower monthly drug costs compared to other ALK inhibitors like lorlatinib and brigatinib[3].

Competitive Landscape

The ALK inhibitors market is highly competitive, with several key players including Pfizer, Takeda, Nuvalent, Hoffmann-La Roche, and Xcovery Holdings. Alectinib, marketed by Genentech, is currently the best-selling ALK inhibitor, with global sales of USD 1.65 billion in 2023. Other competitors like brigatinib and lorlatinib are also vying for market share, but alectinib's dominance is attributed to its efficacy and lower costs[4].

Challenges and Future Directions

Despite the positive market dynamics, there are challenges to be addressed:

• Drug Resistance: Many patients eventually develop resistance to first-line ALK inhibitors, necessitating the development of next-generation therapies[4].
• High Treatment Costs: The high cost of these targeted treatments poses a barrier to access, particularly in low- and middle-income countries[4].

Ongoing research into resistance mechanisms and the development of more affordable treatments are critical for the future growth of the alectinib market.

Recent FDA Approvals and Clinical Trials

The FDA's recent approval of alectinib as an adjuvant treatment for early-stage ALK+ NSCLC marks a significant milestone. The Alina trial demonstrated that alectinib significantly improved disease-free survival and controlled the spread of disease to the brain, offering a chemotherapy-free treatment option for patients[5].

Financial Performance and Revenue Projections

Alectinib's financial performance is robust, with global sales reaching USD 1.65 billion in 2023. The market is expected to continue growing, driven by the increasing incidence of ALK-positive cancers and the expanding use of alectinib in various treatment settings. Revenue projections indicate continued significant expansion from 2023 to 2031, with the market size expected to increase at a CAGR of 3 to 5 percent[1][4].

Key Players and Market Share

Genentech, the manufacturer of alectinib, holds a significant market share in the ALK inhibitors market. The company's dominance is due to the efficacy, safety, and cost-effectiveness of alectinib compared to other ALK inhibitors. Other key players are also investing heavily in research and development to capture a larger share of the market[4].

Consumer Behavior and Economic Landscape

Consumer behavior and economic landscapes play crucial roles in the market dynamics of alectinib. Patients and healthcare providers are increasingly seeking targeted therapies that offer better outcomes and lower side effects. The economic landscape, including healthcare policies and reimbursement strategies, also influences the adoption and affordability of alectinib[3].

Conclusion

The market for alectinib hydrochloride is poised for robust growth driven by its efficacy, cost savings, and expanding clinical use. Despite challenges such as drug resistance and high treatment costs, ongoing research and innovation are expected to address these issues and further solidify alectinib's position in the ALK inhibitors market.

Key Takeaways

• Market Growth: The alectinib market is expected to grow at a CAGR of 3 to 5 percent from 2023 to 2031.
• Economic Impact: Alectinib reduces healthcare costs by preventing or delaying brain metastases in ALK+ NSCLC patients.
• Competitive Landscape: Alectinib dominates the ALK inhibitors market due to its efficacy and lower costs.
• Recent Approvals: FDA approval as an adjuvant treatment for early-stage ALK+ NSCLC marks a significant advancement.
• Future Directions: Ongoing research into resistance mechanisms and more affordable treatments is crucial.

FAQs

What is the current market size of the alectinib drugs market?

The current market size of the alectinib drugs market is estimated in USD million, with projections indicating significant growth from 2023 to 2031[1].

How does alectinib impact healthcare costs?

Alectinib reduces healthcare costs by preventing or delaying brain metastases in ALK+ NSCLC patients, resulting in cost savings of up to $41,434 per patient over a 24-month period[2].

What is the competitive landscape of the ALK inhibitors market?

The ALK inhibitors market is highly competitive, with key players including Genentech, Pfizer, Takeda, and others. Alectinib currently dominates the market due to its efficacy and lower costs[4].

What are the recent FDA approvals for alectinib?

Alectinib was recently approved as an adjuvant treatment for patients after surgical removal of early-stage ALK+ NSCLC, offering a chemotherapy-free treatment option[5].

What are the challenges facing the alectinib market?

Key challenges include drug resistance and the high cost of treatment, which poses a barrier to access in low- and middle-income countries[4].

Cited Sources

1. Market Research Intellect, "Alectinib Drugs Market Size And Forecast", October 2024.
2. PubMed, "Economic impact of preventing brain metastases with alectinib in ALK+ NSCLC patients", 2018.
3. Genentech, Inc., "Budget impact of maintaining alectinib as a preferred treatment option for first-line treatment of ALK+ advanced NSCLC", 2021.
4. PR Newswire, "ALK Inhibitors Market: A Comprehensive Overview of Current Trends and Future Projections", August 2024.
5. Lung Cancer Research Foundation, "FDA approves alectinib for ALK+ NSCLC", May 2024.