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Taro Pharma has filed a patent infringement suit against Suven Life Sciences Ltd on its Abbreviated New Drug Application on malathion lotion. The case was filed in New Jersey District Court, US.
In its ANDA submitted to the US Food and Drug Administration (USFDA), the Hyderabad-based Suven Life had identified Ovide malathion lotion 0.5 per cent of Israel-based Taro Pharma as reference listed drug. It is indicated for patients infected with Pediculus humanus capitis (head lice and their ova) of the scalp hair.
This is a mandatory procedure to be followed by pharma companies while applying for USFDA approval and is called as the Para V Certification. “Based on this Para IV Certification, Taro has filed a complaint against Suven claiming that Suven's proposed malathion product will infringe one or more claims of its patent for the product,” Suven said in a notification to the BSE on Friday.
Taro's patent on malathion lotion will expire on February 1, 2027.
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