Lupin’s US growth plan: 20 complex launches by 2028

A new growth phase led by the next generation

Nearly six decades after it was founded, Lupin is preparing for its next phase of global growth with a sharper focus on the United States. The strategy being outlined by Chief Executive Officer Vinita Gupta and Managing Director Nilesh Gupta is centred on complex generics, biosimilars, and innovation. The shift comes as the company reflects on the life and legacy of its founder, Desh Bandhu Gupta, popularly known as DBG. The leadership spoke about the road ahead in an interaction with Business Standard, shortly after the launch of the book Made in India, which is based on DBG’s life.

While the US remains the key international engine, Lupin is also strengthening its presence in India across chronic therapies and biosimilars. The domestic push is tied to changing demand patterns, with India’s pharma market seeing a larger share of long-term lifestyle therapies relative to acute infection treatments. Lupin’s management has positioned this dual-market focus as the foundation for the company’s next leg of expansion.

How the US business became Lupin’s biggest overseas segment

Lupin entered the US generics market in the late 1990s, at a time when Indian drugmakers were beginning to scale up in regulated markets. Over the years, the US has become the company’s largest international segment. Capitaline data shows Lupin’s US revenue increased from about ₹2,046 crore in FY11 to ₹7,724 crore in FY25. Over the same period, the company’s overall revenue nearly quadrupled to ₹22,708 crore in FY25.

More recent business commentary also underscores how central the US remains to Lupin’s near-term momentum. In what was described as one of its strongest quarters, the United States market contributed 40% of total sales and rose 47% year-on-year to ₹2,762 crore, with growth attributed to high-value launches and exclusivity-led opportunities.

Why Lupin is prioritising complex generics

The company’s stated pipeline priorities are inhalation therapies, injectables, and other complex products that demand deeper technology capabilities and tend to have fewer competitors. Respiratory therapies already represent Lupin’s largest global therapeutic area. Products referenced in its respiratory portfolio include tiotropium and albuterol.

Management has also linked the US performance to products that can command stronger economics versus commodity generics. Swaminathan, in comments tied to the recent quarter’s performance, said: “We ramped up Tolvaptan this quarter, which is under exclusivity as a first-to-file product, and products like Mirabegron continue to do well.” He also said: “Our respiratory portfolio - Albuterol, Spiriva, and Xopenex - provides sustainable moats because of their complex drug-device combinations.”

A clearer launch road map through 2028

Lupin has outlined multiple product milestones across complex generics and biosimilars. It anticipates launching 20 complex products by 2028, specifically pointing to inhalation and injectables as key areas. The company has also said its R&D focus is concentrated on complex generics, biosimilars, and specialty products.

On biosimilars, Vinita Gupta said: “We plan to launch five biosimilars globally over the next five years,” adding that Lupin will target major markets including the US, Europe, and Japan. Separately, Lupin said it has successfully completed global Phase 3 clinical studies for LUBT010. It also plans to file Marketing Authorization for three biosimilars in regulated markets in 2025 and 2026.

India strategy: chronic therapies and new lifestyle categories

Alongside the US, Lupin is sharpening its domestic strategy in chronic therapies such as cardiovascular disease, diabetes, and respiratory conditions. Nilesh Gupta said: “We are already a large cardiometabolic player in India. As newer therapies emerge, we expect to play a meaningful role in those segments as well.”

The company has also flagged obesity and metabolic treatments, including GLP-1-based therapies, as an opportunity area. Lupin expects this segment to become highly competitive once patents expire, but believes its physician relationships and presence in chronic therapies can support market share capture.

Building a separate biosimilars portfolio for India

Lupin is building a separate biosimilars portfolio for the Indian market to improve affordability and access to complex biologic therapies that are described as underpenetrated. The domestic biosimilars plan sits alongside the chronic therapies push and reflects a broader move into higher-complexity products.

In FY25, India contributed 34% to Lupin’s global turnover with revenues of INR 75,773 million, up 13.8% from FY24. Normalised, this India revenue is ₹7,577.3 crore in FY25.

Key numbers at a glance

Market impact: what the shift signals for Lupin and the sector

The US generics market is still described as facing pricing pressure and regulatory challenges, and Lupin has said it wants execution in complex generics, biosimilars, and specialty products to improve profitability. The company’s choice of inhalation and complex injectables aligns with parts of the generics market where barriers are higher and product-device complexity can limit the number of credible competitors. The emphasis on first-to-file and exclusivity-led opportunities also reflects a playbook widely used by larger Indian pharma companies to defend margins in the US.

In India, the shift in demand from acute to chronic therapies is a structural trend that can support steadier prescription franchises. Lupin’s focus on cardiometabolic and respiratory segments matches the chronic mix highlighted by management, and its effort to create a separate biosimilars portfolio points to a longer-term attempt to participate in complex biologics as access expands.

Analysis: why Lupin’s 2025-2028 pipeline matters

The FY11 to FY25 revenue trajectory highlights why the US remains central to Lupin’s growth planning. US revenue rose by about ₹5,678 crore over this period, and the company is now leaning further into segments that require advanced manufacturing, clinical capabilities, and device know-how. The stated targets of launching 20 complex products by 2028 and filing three biosimilars in regulated markets in 2025-2026 provide investors with clearer milestones to track execution.

At the same time, Lupin’s India strategy is framed around protecting and building its chronic franchise while exploring emerging categories such as GLP-1 therapies. The company has acknowledged that competition will increase after patent expiries in such segments, making physician reach and execution a key differentiator rather than exclusivity.

Conclusion

Lupin is mapping its next growth phase around complex generics and biosimilars, with the US as the primary focus and India positioned for chronic and biosimilar expansion. Key signposts include the target of 20 complex launches by 2028, planned biosimilar filings in 2025-2026, and the goal of five global biosimilar launches over the next five years. The next set of updates investors are likely to track are execution milestones on complex launches and the timing of biosimilar regulatory filings in regulated markets.