In a significant development, Lupin Limited, a global pharmaceutical leader, announced a non-exclusive patent licence agreement with Takeda Pharmaceutical Company Limited to commercialise Vonoprazan Tablets in the Indian market. The medication, set to be marketed under Lupin’s brand name Lupivon, will be available in two strengths—10 mg and 20 mg—bringing a novel gastrointestinal drug to a country grappling with high cases of acid-related disorders.

The deal highlights Lupin’s commitment to expanding its gastroenterology portfolio. Rajeev Sibal, President of India Region Formulations at Lupin, said that commercialising Vonoprazan is a step forward in providing innovative medicines to address unmet medical needs. Vonoprazan, a novel potassium-competitive acid blocker (P-CAB), offers distinct advantages over traditional acid suppressants, such as proton pump inhibitors (PPIs). Its ability to inhibit proton pumps with the first dose and its longer action duration promise better treatment outcomes for conditions like acid reflux and peptic ulcers.

Strengthening gastroenterology portfolio

Vonoprazan’s entry into India’s pharmaceutical market is timely, given the high prevalence of acid peptic disorders (APD), including gastroesophageal reflux disease (GERD) and peptic ulcer disease (PUD). With GERD affecting anywhere from 5% to 28.5% of the Indian population and PUD around 8%, the demand for more effective and innovative treatments has never been more pressing. The medication has been approved by India’s Drug Controller General for the treatment of reflux esophagitis, gastric ulcers, duodenal ulcers, and Helicobacter pylori eradication treatment.

This agreement allows Lupin to add Vonoprazan to its gastroenterology offerings in India. The company already holds a strong market presence across multiple therapy areas including respiratory, cardiovascular, and women’s health, among others. Lupin’s global portfolio is backed by 15 state-of-the-art manufacturing sites and seven research centres, making it one of the world’s leading pharmaceutical producers.

Novel drug offers better treatment options

Vonoprazan’s unique attributes make it a game-changer in the treatment of GERD and other acid-related conditions. Unlike PPIs, which take time to show results, Vonoprazan works immediately, offering complete proton pump inhibition with the first dose. Its longer duration of action effectively controls nocturnal acid breakthrough, a common problem faced by patients using conventional PPIs. Additionally, its meal-independent dosing makes it more convenient for patients, potentially improving compliance.

The drug’s availability in India is expected to offer better treatment outcomes for millions suffering from GERD and PUD, both of which are exacerbated by lifestyle factors such as old age, high body mass index (BMI), and dietary habits. Vonoprazan’s ability to offer immediate and long-lasting relief sets it apart from existing treatments, making it a valuable addition to the market.

Expert opinion: A game-changer in acid suppression

The introduction of Vonoprazan could mark a turning point in the treatment of gastrointestinal disorders in India, especially given the limitations of existing treatments. The unique mechanism of action and longer duration of effect make it highly suitable for Indian patients who face lifestyle challenges that contribute to GERD and PUD. Experts believe that by offering a more efficient and immediate treatment option, the drug will likely become a preferred choice among gastroenterologists in the country. Lupin’s move into the gastroenterology space with this innovative drug strengthens its positioning as a leader in India’s pharmaceutical sector.

  Lupin Limited, Lupivon, Rajeev Sibal, Takeda Pharmaceutical Company Limited, Vonoprazan