Mumbai, Baltimore: Pharma major Lupin Limited (Lupin) announced today the launch of Lapatinib Tablets, 250 mg, after Lupin’s alliance partner Natco Pharma Ltd received final approval for its ANDA from the United States Food and Drug Administration (U.S. FDA).

Lapatinib Tablets, 250 mg, are the generic equivalent of Tykerb® Tablets, 250 mg, of Novartis Pharmaceutical Corporation, and are indicated in combination with:

• Capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor receptor 2 (HER2), and who have received prior therapy including an anthracycline, a taxane and trastuzumab
• Letrozole for the treatment of postmenopausal women with hormone-receptor positive metastatic breast cancer that overexpresses the HER2 receptor, for whom hormonal therapy is indicated

Lapatinib Tablets (RLD: Tykerb®) had annual sales of approximately USD 61 million in the U.S. (IQVIA MAT June 2020).

About Lupin

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products and APIs in over 100 markets in the U.S., India, South Africa and across Asia Pacific (APAC), Latin America (LATAM), Europe and Middle-East regions.

The Company enjoys leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS) and women’s health areas. Lupin is the 3rd largest pharmaceutical company in the U.S. by prescriptions and 5th in India by global revenues. The Company invests 9.6 % of its revenues on research and development.

Lupin has fifteen manufacturing sites, seven research centers, more than 20,000 professionals working globally, and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.

Please visit www.lupin.com for more information.

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*Safe Harbor Statement

Tykerb® is a registered trademark of Novartis Pharma AG