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Jubilant receives ANDA approval for Clonidine Hydrochloride ER Tablets


Jubilant receives ANDA approval for Clonidine Hydrochloride ER Tablets

Jubilant Life Sciences has announced that its material wholly owned subsidiary Jubilant Pharma Limited has received Abbreviated New Drug Application (ANDA) final approval for Clonidine Hydrochloride Extended-Release Tablets, 0.1 mg.

This is a generic version of Kapvay of Concordia. It is used for the treatment of attention deficit hyperactivity disorder (ADHD).

As on December 31, 2017, Jubilant had a total of 86 ANDAs for Oral Solids filed in the US of which 56 had been approved and 12 Injectable filings of which 10 had been approved. This is the eighth USFDA approval in FY18.

Clonidine Hydrochloride Extended-Release Tablets, 0.1 mg had annual sales of ~USD 66 million in the US as per IMS MAT Jun 2017.

There are several players in gKapvay already hence we do not see this as a major positive for the stock.



Source: Press Release
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