Zydus Lifesciences to Launch Semaglutide Injection in India
Filing Summary
Zydus Lifesciences Ltd plans to launch its innovative Semaglutide Injection in India immediately upon patent expiry. The product, approved by the Drug Controller General of India, will be marketed under the brand names SEMAGLYN, MASHEMA, and ALTERME. The injection features a novel delivery system allowing adjustable dosing with a reusable pen. This development aims to enhance patient adherence and reduce therapy costs. The launch addresses the growing prevalence of Type 2 Diabetes Mellitus and Obesity in India, with significant health implications for the population.
Zydus Lifesciences Ltd has announced its intention to launch an innovative Semaglutide Injection in India on the first day following the patent expiry. The product will be available under the brand names SEMAGLYN, MASHEMA, and ALTERME. The Drug Controller General of India has granted approval for the manufacturing and marketing of this injection, which is indicated for the treatment of Type 2 Diabetes Mellitus and Obesity.
The financial terms related to the launch of the Semaglutide Injection have not been disclosed in the filing. However, Zydus Lifesciences holds exclusive rights to the innovative drug-delivery system associated with this product. The injection is designed to be administered using a reusable pen, which allows patients to adjust the dosage as needed. This system is intended to improve patient adherence and reduce the overall cost of therapy.
The scope of the launch includes the introduction of a novel, indigenously developed drug-delivery system. This system enables patients to select and administer varying dose strengths from a single unit. Unlike existing treatments that require multiple single-dose pens, the Zydus device offers a more convenient and cost-effective solution. The reusable pen is designed to deliver all strengths approved for the treatment of Type 2 Diabetes Mellitus and Obesity.
The market context for this launch is significant, given the rising prevalence of diabetes and obesity in India. According to the International Diabetes Federation, there are approximately 8.9 crore adults with diabetes in India, representing 10.5% of the total adult population. The prevalence of obesity has also increased, with a 91% rise among women and a 146% rise among men. These statistics highlight the growing public health burden and the potential impact of GLP-1 based therapies like Semaglutide.
The timeline for the launch is set for the day of patent expiry, although specific dates are not provided in the filing. The launch will be managed by Zydus Lifesciences, which has developed the product and secured the necessary regulatory approvals. The company aims to address the needs of patients with Type 2 Diabetes Mellitus and Obesity through this innovative offering.
Zydus Lifesciences Ltd is an innovation-led life-sciences company with a global presence. The company focuses on discovering, developing, manufacturing, and marketing a broad range of healthcare therapies. With over 29,000 employees worldwide, including 1,500 scientists engaged in R&D, Zydus is committed to unlocking new possibilities in life sciences through quality healthcare solutions.