Lupine: January 5, 2023 Lupine launches new fixed-dose three-drug combination DIFIZMA® DPI for the treatment of inadequately controlled asthma

Mumbai, January 05, 2023: Global pharmaceutical company Lupine Limited (Lupin) today announced the launch of a new fixed-dose three-drug combination (FDC) of indacaterol, glycopyrronium and mometasone for the management of inadequately controlled asthma among patients. The company launched this important product under the DIFIZMA® brand in India.

Lupine is the first company in India to offer this new FDC product for dry powder inhalation (DPI) which combines Indacaterol, a long-acting beta-agonist, glycopyrronium, a long-acting muscarinic receptor antagonist, and Mometasone Furoate, an inhaled corticosteroid.

DIFIZMA® is the only FDC approved by the Drug Controller General of India (DCGI) for the treatment of inadequately controlled asthma. DIFIZMA® will aid in the management of inadequately controlled asthma by improving lung function, providing better symptom control and reducing exacerbations. The drug will be available in one dosage with a fixed dose to be taken once a day.

The estimated national burden of asthma in India is 17.23 million with an overall prevalence of 2.05%. Of these, around 30 lakh patients can be classified as ‘inadequately controlled’. These are the patients who have uncontrolled symptoms and a higher chance of exacerbations that can lead to hospitalization contributing to higher DALYs (disability adjusted life years) in the majority of patients.

Commenting on the launch, Mr. Rajeev Sibal, President – India Region Formulations, Lupine said, “We are excited about the launch of DIFIZMA®, a first-of-its-kind new combination product available in India. DIFIZMA® aims to address the unmet needs of patients with inadequately controlled asthma and closely aligns with Lupine’s ideology of patient-centeredness and enable accessibility for medications.”

The launch of DIFIZMA® aligns with Lupine’s commitment to introducing new inhalation products globally. In India, Lupine ranks second in the area of ​​respiratory therapy (IQVIA, MAT Nov 2022) and this launch will further strengthen the company’s presence in the segment.

About Lupine

Lupine is an innovation-driven transnational pharmaceutical company headquartered in Mumbai, India. The company develops and markets a broad range of branded and generic formulations, biotechnology products and APIs in more than 100 markets in the United States, India, South Africa and Asia Pacific (APAC), Latin America (LATAM), Europe and of the Middle East.

The Company enjoys a leadership position in the cardiovascular, anti-diabetic and respiratory segments and has a significant presence in the anti-infectious, gastrointestinal (GI), central nervous system (CNS) and women’s health areas. Lupine is the third largest pharmaceutical company in the United States by prescriptions. The company invested 8.7% of its R&D revenue in the AF22.

Lupine has 15 manufacturing plants, 7 research centers, more than 20,000 working professionals worldwide, and has been consistently recognized as a “Great Place to Work” in the biotechnology and pharmaceuticals industry.

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For further information or questions please contact –

Shweta Munjal
Vice President and Global Head – Corporate Communications
Email: [email protected]

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