Glenmark Generics Inc.(GGI), USA, the United States subsidiary of Glenmark Generics Limited (GGL), announced that the US Food and Drug Administration (US FDA) has granted tentative approval for their generic version of IPR’s migraine treatment zomig tablets.
Glenmark believes there are no first to file applicants for zolmitriptan tablets and therefore the company would commence marketing and distribution of their zolmitriptan product upon patent expiration in May 2013. Product launch is dependent upon receipt of final approval of its Abbreviated New Drug Application (ANDA) from the US FDA.
The tentative approval granted by the US FDA is for the 2.5 mg and 5 mg tablets of zolmitriptan and constitutes one of two tentative approvals granted for a generic version of the drug.
IMS Health has reported sales for the 12 month period ending June 2011 as US$ 141 million.
Glenmark’s current portfolio consists of 73 generic products authorized for distribution in the US market. The company currently has 40 ANDAs filed with the US FDA pending approval. In addition to these internal filings, GGI continues to identify and explore external development partnerships to supplement and accelerate the growth of the existing pipeline and portfolio.
GGL is a subsidiary of Glenmark Pharmaceuticals Limited (Glenmark) and aims to be a global integrated Generic and API leader.