Lupin expects to launch 20 products in US next fiscal

Company has 26 first-to-file opportunities in US market out of which 12 are exclusive opportunities, says Lupin Group President Vinita Gupta

Drug major Lupin expects to strengthen its US pipeline by launching around 20 products in the next fiscal (2014-15) and aims to sharpen focus on less-competitive segments like oral contraceptives and ophthalmology.

 

"In the US, we have multiple new product launches planned; we should have 15-20 product launches subject to US Food and Drug Administration (USFDA) approval in the next fiscal year," Lupin Group President and CEO Designate Vinita Gupta told PTI.

 

Gupta, who is also the CEO of Lupin's US-based subsidiary--Lupin Pharmaceuticals Inc, said the company has 26 first-to-file opportunities in the US market out of which 12 are exclusive opportunities, most of which are yet to be launched.

 

The Mumbai-based firm's cumulative abbreviated new drug applications (ANDA) filings with the USFDA, as of March 31, 2013, stood at 176 with the company having received 78 approvals to date.

 

As part of its plans to achieve faster growth in the US market, the Rs 9600-crore company has been focusing on less competitive segments including oral contraceptives (OCs) and ophthalmology.

 

"A less competed for space, OCs are a very niche segment and requires a high level of R&D expertise, active pharmaceutical ingredients (API) strengths and manufacturing competencies," Gupta said.

 

As per industry sources, the oral contraceptive market in the US is valued at around $5 billion and growing at around 10% annually.

 

"This is a segment where it makes sense to have a complete basket of products so that one can drive serious value into the market and Lupin would be one of the few innovators to drive it in," Gupta said.

 

Lupin's current ANDA filings for OCs stand at 32.

 

"We are similarly targeting the ophthalmology and dermatological and building a similar pipeline for these segments. Lupin has already done over 10-12 filings with the USFDA for ophthalmological products," Gupta added.

 

The company's US and Europe formulation sales grew by 47% to Rs 4,005.1 crore during 2012-13 contributing 42% to overall sales.