LAPATINIB DITOSYLATE - Generic Drug Details

What are the generic sources for lapatinib ditosylate and what is the scope of freedom to operate?

Lapatinib ditosylate is the generic ingredient in two branded drugs marketed by Natco Pharma Ltd, Teva Pharms Usa Inc, and Novartis, and is included in three NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Lapatinib ditosylate has twenty-eight patent family members in twenty-six countries.

There are six drug master file entries for lapatinib ditosylate. Two suppliers are listed for this compound.

Summary for LAPATINIB DITOSYLATE

International Patents:	28
US Patents:	1
Tradenames:	2
Applicants:	3
NDAs:	3
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	238
Clinical Trials:	67
Patent Applications:	2,565
DailyMed Link:	LAPATINIB DITOSYLATE at DailyMed

Recent Clinical Trials for LAPATINIB DITOSYLATE

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

Sponsor	Phase
Stanford University	Phase 2
Jonsson Comprehensive Cancer Center	Phase 1/Phase 2
Washington University School of Medicine	Phase 2

See all LAPATINIB DITOSYLATE clinical trials

Pharmacology for LAPATINIB DITOSYLATE

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for LAPATINIB DITOSYLATE

L01EH	Human epidermal growth factor receptor 2 (HER2) tyrosine kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for LAPATINIB DITOSYLATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TYKERB	Tablets	lapatinib ditosylate	250 mg	022059	1	2011-03-14

US Patents and Regulatory Information for LAPATINIB DITOSYLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Natco Pharma Ltd	LAPATINIB DITOSYLATE	lapatinib ditosylate	TABLET;ORAL	203007-001	Sep 29, 2020	AB	RX	No	No
Novartis	TYKERB	lapatinib ditosylate	TABLET;ORAL	022059-001	Mar 13, 2007	AB	RX	Yes	Yes			Y	Y
Teva Pharms Usa Inc	LAPATINIB DITOSYLATE	lapatinib ditosylate	TABLET;ORAL	217968-001	Aug 16, 2024	AB	RX	No	No

Expired US Patents for LAPATINIB DITOSYLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	TYKERB	lapatinib ditosylate	TABLET;ORAL	022059-001	Mar 13, 2007
Novartis	TYKERB	lapatinib ditosylate	TABLET;ORAL	022059-001	Mar 13, 2007
Novartis	TYKERB	lapatinib ditosylate	TABLET;ORAL	022059-001	Mar 13, 2007
Novartis	TYKERB	lapatinib ditosylate	TABLET;ORAL	022059-001	Mar 13, 2007

International Patents for LAPATINIB DITOSYLATE

Country	Patent Number	Title	Estimated Expiration
Brazil	PI0609962	composição farmacêutica oral, e, método para tratar um distúrbio em um mamìfero
South Korea	101356748
European Patent Office	1871347	PREPARATION PHARMACEUTIQUE (PHARMACEUTICAL COMPOSITION)
Norway	20075111

Supplementary Protection Certificates for LAPATINIB DITOSYLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1047694	08C0038	France		PRODUCT NAME: LAPATINIB OU UN DE SES SELS OU PRODUITS DE SOLVATATION; REGISTRATION NO/DATE: EU/1/07/440/001-002 20080610
1047694	SPC/GB08/044	United Kingdom		PRODUCT NAME: LAPATINIB OR A SALT OR SOLVATE THEREOF; REGISTERED: UK EU/1/07/440/001 20080610; UK EU/1/07/440/002 20080610
1047694	CA 2008 00040	Denmark		PRODUCT NAME: LAPATINIB ELLER ET SALT ELLER SOLVAT DERAF, HERUNDER LAPATINIBDITOSYLATMONOHYDRAT
1047694	PA 2008012, C1047694	Lithuania		PRODUCT NAME: LAPATINIBUM DITOSYLATUM MONOHYDRICUM; FIRST REGISTRATION NO/DATE: EU/1/07/440/001-002 20080610

LAPATINIB DITOSYLATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Lapatinib Ditosylate

Introduction

Lapatinib ditosylate, a crucial anti-cancer drug developed by GlaxoSmithKline (GSK), has been a significant player in the treatment of solid tumors, particularly breast and lung cancer. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Size and Growth

The Lapatinib Ditosylate API Market has experienced substantial growth in recent years. As of 2023, the market size was valued at several billion USD, and it is anticipated to reach even higher figures by 2031, with a projected Compound Annual Growth Rate (CAGR) of around 4.4% from 2024 to 2030[4].

Segmentation

The market is segmented based on several key factors:

• Type: The market is categorized into segments based on the purity of the API, including Min Purity Less Than 98%, Min Purity 98%-99%, and Min Purity More Than 99%[1][4].
• Application: The primary applications are in Research and Pharmaceutical sectors[1][4].
• Geography: The market is analyzed across regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa[1][4].

Drivers and Opportunities

Several factors drive the growth of the Lapatinib Ditosylate API Market:

• Increasing Incidence of Cancer: The rising prevalence of breast and lung cancers globally increases the demand for effective treatments like lapatinib ditosylate.
• Advancements in Medical Research: Continuous advancements in cancer research and the development of targeted therapies contribute to market growth.
• Government Initiatives and Funding: Government support and funding for cancer research and treatment programs also boost the market[1][3].

Restraints and Challenges

Despite the positive growth trajectory, the market faces several challenges:

• Side Effects and Safety Concerns: Lapatinib ditosylate is associated with side effects such as diarrhea, hepatotoxicity, and decreased left ventricular ejection fraction, which can impact its adoption[5].
• Regulatory Hurdles: Strict regulatory requirements and the need for continuous monitoring of liver function and other safety parameters can slow market growth.
• Competition from Alternative Treatments: The presence of other cancer treatments and the ongoing development of new therapies can pose competition to lapatinib ditosylate[1][3].

Key Players

The market is dominated by several key players:

• Huirui Pharma
• Shengda Pharmaceutical
• Shijiazhuang Dingmin Pharmaceutical Sciences
• ScinoPharm Taiwan
• Shandong Boyuan Pharmaceutical
• Hetero
• Vannsh Life Sciences
• Natco Pharma[1][4].

These companies play a crucial role in the production, distribution, and innovation within the lapatinib ditosylate market.

Financial Projections

The financial trajectory of the Lapatinib Ditosylate API Market is promising:

• Current Market Size: The market was valued at around USD 13 million in 2024.
• Forecasted Growth: It is expected to reach USD 17 million by 2030, with a CAGR of 4.4% during the forecast period[4].
• Revenue and Volume Forecast: Detailed forecasts include revenue and volume projections, providing a comprehensive view of the market's financial health[3].

Regional Analysis

The market's performance varies across different regions:

• Asia-Pacific: This region is expected to show significant growth due to increasing cancer incidence and improving healthcare infrastructure.
• North America and Europe: These regions continue to be major markets due to advanced healthcare systems and high demand for cancer treatments[1][3].

Competitive Landscape

The competitive landscape is characterized by:

• Market Share: The top three players hold a significant share of the market, over 29%[4].
• Product Differentiation: Companies focus on differentiating their products through purity levels and application-specific formulations.
• Research and Development: Continuous R&D efforts to improve efficacy and reduce side effects are key competitive strategies[1][3].

Porter's Five Forces Analysis

The market dynamics can be further understood through Porter's Five Forces Framework:

• Threat of New Entrants: High barriers to entry due to regulatory and technological requirements.
• Bargaining Power of Suppliers: Moderate, as suppliers of raw materials have some leverage but are not dominant.
• Bargaining Power of Buyers: High, as buyers (pharmaceutical companies and research institutions) have significant negotiating power.
• Threat of Substitute Products: Moderate, as alternative cancer treatments are available but lapatinib ditosylate has a unique mechanism of action.
• Competitive Rivalry Among Existing Competitors: High, due to the presence of multiple key players and ongoing competition in innovation and market share[1][3].

Conclusion

The Lapatinib Ditosylate API Market is poised for significant growth driven by increasing cancer incidence, advancements in medical research, and government initiatives. However, it faces challenges such as side effects, regulatory hurdles, and competition from alternative treatments. Key players are focusing on product differentiation, R&D, and expanding their market share. The financial projections indicate a steady growth trajectory, making this market an attractive segment for investment and innovation.

Key Takeaways

• Market Growth: Expected to grow at a CAGR of 4.4% from 2024 to 2030.
• Segmentation: Categorized by type, application, and geography.
• Drivers: Increasing cancer incidence, medical research advancements, and government support.
• Challenges: Side effects, regulatory hurdles, and competition.
• Key Players: Huirui Pharma, Shengda Pharmaceutical, ScinoPharm Taiwan, among others.
• Financial Projections: Market size expected to reach USD 17 million by 2030.

FAQs

Q: What is lapatinib ditosylate used for? A: Lapatinib ditosylate is used as a treatment for solid tumors, particularly breast and lung cancer, by inhibiting HER2 and EGFR tyrosine kinases[2].

Q: What are the common side effects of lapatinib ditosylate? A: Common side effects include diarrhea, hepatotoxicity, decreased left ventricular ejection fraction, and interstitial lung disease[5].

Q: Which regions are expected to dominate the lapatinib ditosylate market? A: Asia-Pacific, North America, and Europe are expected to be major markets due to their healthcare infrastructure and demand for cancer treatments[1][3].

Q: Who are the key players in the lapatinib ditosylate market? A: Key players include Huirui Pharma, Shengda Pharmaceutical, Shijiazhuang Dingmin Pharmaceutical Sciences, ScinoPharm Taiwan, and others[1][4].

Q: What is the projected CAGR for the lapatinib ditosylate market from 2024 to 2030? A: The market is expected to grow at a CAGR of 4.4% during this period[4].

Sources

1. Market Research Intellect: Lapatinib Ditosylate API Market Size, Scope And Forecast Report.
2. DrugBank Online: Lapatinib ditosylate.
3. Cognitive Market Research: Lapatinib Market Report 2024 (Global Edition).
4. Valuates Reports: Global Lapatinib Ditosylate API Market Insights, Forecast to 2030.
5. FDA: 022059Orig1s007 - Lapatinib Clinical Trial Data.