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US court restrains Lupin from selling generic drug 'Fortamet'

09 Dec 2011 Evaluate

Japan's Shionogi & Co has procured an injunction order against Lupin, barring the domestic entity from further selling a generic version of Fortamet, a drug used to treat diabetes, in the US. However, the US court denied the motion of Shionogi for recall of Lupin's already distributed generic Fortamet during the two weeks of at-risk launch in October 2011. The preliminary injunction prevents Lupin from further importing and selling a generic version of Fortamet [R] before the district court renders a decision in the on-going litigation.

Further, the US District Court in New Jersey ordered Shionogi to deposit a security bond of $15 million for losses likely to be suffered by Lupin in next one year, pending the outcome of the case. Earlier on September 30, 2011, Lupin had launched the generic Fortamet at-risk triggering its 180-days exclusivity. However, on October 12, 2011, Shionogi filed a preliminary injunction in court to prohibit Lupin from further selling of the product.The court, on October 17, 2011, issued an order enforcing standstill agreement whereby Lupin agreed not to sell any generic Fortamet in US until the next court hearing concerning the preliminary injunction. Lupin had partially monetised the opportunity by filling the channels in the two weeks of October 2011 at-risk launch. Further, if Lupin is able to secure favourable judgement in the case then it would receive $15 million from Shionogi Pharma as part of compensation.

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