(Yicai Global) June 20 -- A generic antidepressant drug developed by a holding subsidiary of Humanwell Healthcare Group has obtained a registration number approved by the US Food and Drug Administration, facilitating the company’s expansion into the generic drug market in the United States.
Yichang Humanwell Pharmaceutical has obtained the FDA-approved registration number for a generic drug of bupropion hydrochloride extended-release tablets, an antidepressant used to treat major depressive and seasonal affective disorder, the company said in a statement yesterday.
Yichang Humanwell’s cumulative research and development investment for the generic drug was nearly USD1.3 million, it said. At present, Canada’s Valeant Pharmaceuticals holds a patent for the drug, which will expire in the end of October. No party has so far claimed that Yichang Humanwell’s product infringes Valeant’s patent right, the statement added.
The total sales of bupropion hydrochloride extended-release tablets in the US market nearly USD700 million last year, shows publicly available information, while its sales in China’s public hospitals amounted to about CNY30 million (USD4.6 million).
Editor: Mevlut Katik