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The United States Food and Drug Administration (USFDA) has cleared Montelukast Sodium, a bulk drug/active pharmaceutical ingredient (API) manufactured by Morepen Laboratories for sale in the US market. This gives Morepen an entry into the Rs 2000 crore (approximately $300 million) US market for Montelukast. The first commercial orders for the bulk drug are expected in Q2 of FY 2018-2019.

Montelukast's global market is estimated at about Rs 13000 crore (approximately $2 billion) out of which US market alone is Rs 2000 crore. The patent for Montelukast has expired in all the markets worldwide. In US, the product patent got expired in 2012 and subsequently process patent expired in 2014.

Montelukast is another blockbuster product for Morepen after Loratadine. Morepen is amongst the largest producers of Montelukast globally with an annual capacity of more than 30 tons. Besides, Morepen is the market leader for Montelukast in India with over 50% market share, supplying to almost all major finished dosage manufacturers in India. Already crossed Rs 100 crore annual sales from Montelukast Sodium alone, Morepen is going to get a business of around Rs 500 crore from this API in next 3-4 years, the company said in a statement.

Net profit of Morepen Laboratories rose 24.5% to Rs 10.38 crore on 3.1% decline in net sales to Rs 138.24 crore in Q2 September 2017 over Q2 September 2016.

Morepen Laboratories is a pharmaceutical and healthcare products company. It is engaged in the manufacturing and sale of APIs/ bulk drugs, home diagnostics, formulations and over-the-counter products.