Lupin aims to launch around 30 generic products in the US

With rapid approvals from US health regulator anticipated, homegrown drug major Lupin 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 (ANDAs) pending approval with the US Food and Drug Administration (US FDA).

The drug firm is banking on introduction of complex generics and biosimilars in the US 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 US last fiscal (2017-18), with 10 in the last quarter (January-March) alone. We expect to launch 25-30 products in US this year," said Nilesh Gupta, Managing Director, Lupin.

Lupin, which is the fourth largest generics player in the US market by prescriptions, is looking to maintain its position in the market.

According to industry estimates, the US prescriptions market is pegged at around $450 billion currently and is expected to cross $600 billion by 2021.

"Our efforts to maintain leadership position include bringing complex generics and biosimilars to market while continuing our focus on exclusive and semi-exclusive products in the oral and injectable space," Gupta said.

The company’s focus remains on inhalation, injectables and biosimilars in the US, he added.

"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 EU and is progressing towards building a strong pipeline of biosimilars for multiple markets, he added.

Gupta said on the speciality drugs side the company’s growth will be driven by Solosec this year which is its 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.

When asked about challenges in the US market, Gupta said the company has witnessed significant pressures in the past two years and expects things to become better going ahead.

"We feel that the worst of the price and market erosion is behind us. All stakeholders within the US 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 ₹ 15,560 crore, a decline of 9 per cent from 2016-17.

During the last fiscal, company’s North America sales declined by 28.7 per cent to
₹ 5,893.9 crore, accounting for 38 per cent of its total global sales.