Glenmark plans new launches in US, receives FDA nod for anticoagulant drug

Pradaxa is Glenmark's fourth product approval in the US from January till date

Drug-maker Glenmark on Wednesday received a tentative approval from the US Food and Drugs Administration (USFDA) to sell the generic version of its drug Pradaxa, used to prevent blood clots. 

Pradaxa had annual sales of over $900 million last year.

This is Glenmark’s fourth product approval in the US since January till date. It is significant as the company looks to sustain revenue growth in the market. 

Along with 8-10 per cent pricing pressure, the pharmaceutical giant is also expected to face competition to its top selling anti-cholesterol drug Zetia later this year.

The company is aiming to launch new products in the US and is focusing on complex drugs and new dosage forms to sustain its revenue growth. 

In FY17, the drug maker launched 15 products in the US market and is aiming to launch 20 products annually over the next few years.

Glenmark earned about 40 per cent of revenue from the US market in the first nine months of FY17. Sales have ramped up following the launch of Zetia in December. 

The company’s fourth quarter revenue is estimated to grow over 30 per cent on a year-on-year basis. 

According to Nomura Research, Zetia’s sales in the fourth quarter is likely to be at $125 million.

Nirmal Bang Institutional Equities, in its recent investor note, said Glenmark would file for 18-20 products annually.

The brokerage expects the drug maker to receive approvals for 13-15 products, including 2-3 dermatology products in FY18.

The company is developing specialty in dermatology and respiratory products as a part of its growth strategy, besides working on inhalers and new dosage forms to achieve a higher growth in the US.