An employee holds Ramipril capsules for a photograph inside a coating unit at the Lupin Ltd. pharmaceutical plant in Salcette, Goa, India. (Photographer: Dhiraj Singh/Bloomberg)

Lupin Ltd. To Launch Nearly 30 Products In U.S. Market This Financial Year

With rapid approvals anticipated from U.S. health regulators, home-grown drug major Lupin Ltd. sees opportunity to launch around 30 generic products in the world's largest pharmaceuticals market this year, according to a top company official.

The Mumbai-based company currently has 162 abbreviated new drug applications approvals pending with the U.S. Food and Drug Administration. The drug firm is banking on introduction of complex generics and biosimilars in the U.S. besides continuing focus on exclusive and semi-exclusive products in oral and injectable space to maintain its top five position in the market.

"We launched 23 products in the U.S. in the financial year ending 2017-2018, with 10 in the last quarter (January-March) alone. We expect to launch 25-30 products in U.S. this year," Lupin Managing Director Nilesh Gupta said. Lupin, which is the fourth largest generics player in the U.S. market by prescriptions, is looking to maintain its position in the market.

According to industry estimates, the U.S. prescriptions market is pegged at around $450 billion currently and is expected to cross $600 billion by 2021. The company's focus remains on inhalation, injectables and biosimilars in the U.S., he added.

Also read: FDA Warns Indian Pharma Lupin on Repeated Quality Violations

"Lupin's first set of injectable generics will hit the market this year, and multiple products will be filed to ramp up our presence in this space this year," Gupta said. The company has also filed its first biosimilar in both Japan and the European Union and is progressing towards building a strong pipeline of biosimilars for multiple markets, he added.

On the specialty drugs side, the company's growth will be driven by Solosec this year. Solosec is Lupin’s major foray into women's health catering to an unmet medical need of bacterial vaginosis. "We have a multi-pronged approach, using M&As, partnerships, and R&D to continue adding to the pipeline," he added.

Also read: Lupin Sees U.S. Pain Till 2020, Bets On Women’s Health To Offset Pricing Fall

When asked about challenges in the U.S. market, Gupta said the company has witnessed significant pressures in the past two years and expects things to become better while moving forward.

"We feel that the worst of the price and market erosion is behind us. All stakeholders within the U.S. pharma market, customers, distributors manufacturers and regulators recognise that the market deterioration over the past couple years is not sustainable," Gupta said.

In the near term, the company expects to see new competition and faster approvals on simpler generics, which will continue to impact pricing in these categories, he added. Lupin expects single-digit sales growth this fiscal.

The drug maker had reported negative growth in 2017-18 for the first time in a decade, with net sales dropping to Rs 15,560 crore, a decline of 9 percent from 2016-17. In the previous financial year, the company's North America sales declined by 28.7 percent to Rs 5,893.9 crore, accounting for 38 percent of its total global sales.