Sun Pharmaceutical announced Wednesday the U.S. Food and Drug Administration (FDA) has approved its Supplemental New Drug Application (sNDA) for XiminoTM (Minocycline HCl) extended-release capsules 45 mg, 90 mg and 135 mg. XiminoTM extended-release capsules are indicated for inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older.

This approval further strengthens the company's branded dermatology portfolio in the US. It expects XiminoTM extended-release capsules to be available for patients during the fourth quarter of 2015.
 
The US market is the largest market for the global acne products with about 50mn suffering from acne in the country. As of January 31, 2015 is a USD 3 billion market in the US branded prescription market. The market is split between oral antibiotics ($1.7bn in sales) or lotions, creams and ointments ($1.3bn in sales).

Commenting on the product approval, Angel Broking said, "The acne market is so fragmented that numerous companies are selling hundreds of millions worth of drug treatments. Thus, the landscape is very competitive, with no dominant leader. The most prominent brand in the US Solodyn has US sales of US$ 300-400mn.

Thus, the product can garner decent sales from the product. However given the generic competition, conservatively we estimate the product can contribute around US$ 50-80mn to the annual sales of the company, with net profit around USD 25-40mn."

Angel Broking has Neutral rating on the stock.

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