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388082-78-8,Lapatinib ditosylate monohydrate,The latest news,ANQING CHICO PHARMACEUTICAL CO., LTD.

Keywords:
Lapatinib, Tykerb, HER2-positive breast cancer, tyrosine kinase inhibitor, market analysis, generics, pharmaceutical competition

Introduction:
Lapatinib, marketed under the trade names Tykerb and Tyverb, is an orally active small molecule used primarily in the treatment of HER2-positive breast cancer. Developed by GlaxoSmithKline (GSK), Lapatinib functions by inhibiting the tyrosine kinase domains of both the epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2), thereby interrupting tumor cell proliferation. The drug received FDA approval in March 2007 for use in combination with capecitabine for patients with advanced or metastatic breast cancer who had previously undergone therapy including an anthracycline, a taxane, and trastuzumab.  

Chemical Properties:

• Chemical Name: Lapatinib ditosylate monohydrate

• CAS Number: 388082-78-8

• Molecular Formula: C41H40ClFN4O11S3

• Molecular Weight: 925.46 g/mol

• Structure: Lapatinib is characterized by its quinazoline core structure, which is essential for its inhibitory activity against tyrosine kinases.

Original Research and Manufacturers:
Lapatinib was initially developed by GlaxoSmithKline (GSK) and is marketed under the names Tykerb (primarily in the U.S.) and Tyverb (in Europe and other regions). In 2015, GSK's oncology portfolio, including Lapatinib, was acquired by Novartis, which now oversees its global distribution.

Approval Timeline:

• March 13, 2007: FDA approval for use in combination with capecitabine for advanced or metastatic HER2-positive breast cancer.

• January 2010: Accelerated FDA approval for combination with letrozole for postmenopausal women with hormone receptor-positive metastatic breast cancer overexpressing HER2.  

Market Performance and Sales (2020–2024):
The introduction of generic versions and evolving treatment paradigms have influenced Lapatinib's market performance over recent years.

Note: The 2020 sales figure is based on IQVIA data. Subsequent years are estimations considering market trends and the impact of generic competition.

Market Competition and Generics:
The expiration of Lapatinib's patent in the U.S. in 2020 paved the way for generic manufacturers to enter the market. Notably:

• Natco Pharma Ltd: Received FDA approval for generic Lapatinib tablets in September 2020.

• Teva Pharmaceuticals USA Inc: Gained FDA approval for its generic version in August 2024.  

The introduction of generics has intensified competition, leading to reduced prices and impacting the sales of branded versions.

Global Market Dynamics:
The global Lapatinib ditosylate API market was valued at approximately USD 14 million in 2023 and is projected to reach USD 19 million by 2030, growing at a CAGR of 4.2%. Europe holds the largest market share at 66%, followed by the Asia Pacific and the Middle East & Africa regions.  

Conclusion:
Lapatinib has played a pivotal role in the management of HER2-positive breast cancer. While the emergence of generics has introduced pricing pressures, it has also enhanced accessibility for patients worldwide. Continuous monitoring of market trends and ongoing research will determine Lapatinib's position in the evolving oncology therapeutic landscape.

References:

1. Tykerb (lapatinib ditosylate) FDA Approval History. Drugs.com.

2. Lupin Launches Lapatinib Tablets. Lupin.

3. Generic Tykerb Availability. Drugs.com.

4. Lapatinib. Wikipedia.

5. Lapatinib Ditosylate API Market Research 2024. News Channel Nebraska.  

Active Pharmaceutical Ingredient

388082-78-8,Lapatinib ditosylate monohydrate,(chemical grade, purity ≥99.0%) are currently supplied by our company. [Own compliance factory, fully support factory audit] For details, you can call the bottom line to get the latest price of the product!

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