Glenmark introduces generic Hydrocortisone Butyrate cream in US
The product is used for treating various skin conditions in the US and is entitled to 180 days exclusivity.
New Delhi, December 10, 2013: Glenmark Pharmaceuticals' US arm has launched the generic Hydrocortisone Butyrate cream used for treating various skin conditions in the US and is entitled to 180 days exclusivity.
The company said in a recent statement that Glenmark Generics Inc, USA, the subsidiary of Glenmark Generics Ltd announces the exclusive launch of Hydrocortisone Butyrate cream USP, 0.1 per cent in the United States.
It may be noted here that the company is entitled to 180 days of exclusivity as it is the first generic company to file for an ANDA for the product. The company also highlighted the fact that it received approval from USFDA for its ANDA for generic version of AstellasPharma'sLocoidLipocream on September 27, 2013.
The company now has 90 products authorised for distribution in the US market and 56 ANDA's pending approval with the US regulator.
It is important to note that the product registered a sale of almost US$ 36.8 million for the 12 month period ending September 2013.