Three Drugs, One Inhaler: Major COPD Breakthrough Enters India

Lupin Limited has launched Formoflo-G MDI, which it describes as the world’s first fixed-dose triple-combination metered-dose inhaler for chronic obstructive pulmonary disease management in India.

The product, approved by the Drug Controller General of India, combines Glycopyrronium Bromide, Formoterol Fumarate and Fluticasone Propionate in a single twice-daily inhaler. It is indicated for the long-term management and treatment of moderate to severe chronic obstructive pulmonary disease, or COPD.

The launch expands Lupin’s respiratory offering in a large chronic-care market. The company said India has more than 55 million people living with COPD, a condition that remains among the leading causes of death and disability in the country. By bringing three established therapies into one fixed-dose inhaler, Formoflo-G gives physicians an additional treatment option for suitable COPD patients.

The launch is strategically aligned with Lupin’s effort to increase its presence in differentiated respiratory products, a segment where drug-device development, regulatory approvals and manufacturing capabilities can create higher entry barriers than conventional oral generics.

Lupin was ranked No. 2 in India’s respiratory therapy segment in IQVIA MAT March 2026. The company is also strengthening its chronic-care mix in the domestic formulations business, where respiratory, cardiac and diabetes therapies are key focus areas. In the June 2026 quarter, Lupin’s India business grew 13.9 per cent year-on-year, while chronic therapies accounted for around 67 per cent of its domestic portfolio.

Nilesh Gupta, Managing Director of Lupin, said access to effective therapies remained important as respiratory illnesses affect millions of patients. ‘Formoflo-G MDI reflects our commitment to addressing unmet patient needs through differentiated, high-quality therapies,’ he said.

Rajeev Sibal, President, India Region Formulations, said the product brought together three established therapies in a single inhaler and would provide healthcare professionals with another treatment choice for appropriate COPD patients.

The product introduction comes as Lupin seeks to build a more complex and differentiated portfolio across respiratory therapies, injectables, biosimilars and specialty medicines. Its broader respiratory pipeline includes more than 20 products, spanning metered-dose inhalers, dry-powder inhalers, nasal sprays and other inhalation platforms.

The company’s respiratory ambitions extend beyond India. Management has identified inhalation products as an important pillar of its US growth strategy, where respiratory therapies already contribute more than 20 per cent of the base business. Lupin has also indicated plans for several respiratory filings in the US market during FY27, including products based on more complex inhaler and device platforms.

Financially, Lupin reported net sales of Rs 8,276.89 crore for the quarter ended June 30, 2026, up 32.04 per cent year-on-year. However, its operating margin moderated sequentially, with PBIDT margin excluding other income at 29.60 per cent compared with 33.25 per cent in the March quarter. Management has cautioned that profitability could normalise as competition increases in certain US products and costs linked to geopolitical disruptions flow through the business.

As of 10:20 am on October 6, 2026, Lupin shares were trading at Rs 2,014.00, down 0.74 per cent from the previous close. The stock was about 19.9 per cent below its 52-week high of Rs 2,514.40, although it remained 5.7 per cent above its 52-week low. Over the past year, the stock gained 1.17 per cent, compared with a 3.22 per cent decline in the BSE 500.

For Lupin, Formoflo-G MDI is unlikely to materially alter earnings immediately, as the company has not disclosed pricing or revenue expectations. However, it supports the longer-term strategy of raising the share of chronic and differentiated therapies in India, where respiratory remains an established franchise and COPD treatment needs remain substantial.

Disclaimer: The article is for informational purposes only and not investment advice.