Lupin in fast lane with 5 launches in 15 days

New products expected to offset price erosion in the US

Mumbai-based Lupin launched the generic version of Allergan’s contraceptive pill, Minastrin, in the US, with an 180-day sales exclusivity. The product has a market size of $361 million and will provide the Indian company significant profit opportunity. 

This is the fifth product launch by the company in the last 15 days and the ninth one since its Goa plant got a final approval from the US Food and Drug Administration (USFDA) in November. These product launches come at a time when Indian generic makers are facing pricing pressure in US markets.

“The company is significantly dependent on two products (Glumetza and Fortamet), which are now seeing pricing pressure in the US markets,” said Amey Chalke, analyst at HDFC Securities. “These new launches will help the company off-set the impact of price erosion,” he added. 

The US business contributed over 40 per cent of the company’s Rs 12,957-crore revenue in the first nine months of this financial year (FY17). 

About a month back, in an investors’ call, the chief executive officer of the company, Vinita Gupta, indicated Lupin would be launching 25 products in 12 months. The company is also ramping up production at its facility in Gavis, US, which will help it speed up launches. 

India’s second-largest generic exporter has already got the maximum 23 approvals for launching generic products in the US market. The market size for these 23 drugs is $5.2 billion, according to sales figures from the IMS.

These include limited-competition and complex products such as HIV drug Epzicom and anti-depressant Bupropion XL, besides products from the controlled substances category. It is also growing its branded products business in the US and has seen increased sales of oral uterotonic Methergine. 

Sun Pharmaceuticals, the largest Indian generics exporter has got final approvals for 16 formulations in the current financial year, though the market size for these drugs is higher at $11.4 billion. 

The top five Indian generic exporters have together got final approval for 66 formulations from the US FDA in the current financial year, with a market size of $20 billion.

“With one of the strongest pending pipelines in the US (137 pending approvals) at its disposal, the company is well poised to address the pricing issue,” said Siddhant Khandekar, an analyst with ICICI Securities. 

In 2015, the US FDA served Form 483 on Lupin’s oral solids and formulation plant in Goa. It is used by the regulator to document and communicate concerns discovered during an inspection. The Goa plant accounts for 50 per cent of Lupin’s US sales.