Taro Pharma challenges Suven's ANDA in US court
06 May 2011
Israeli drug maker Taro Pharma, in a suit filed in the New Jersey District Court in the US, has challenged Suven Life Sciences's ANDA 091559.
In its abbreviated new drug application No 091559, Suven Life Sciences has sought approval from the United States Food and Drug Administration (US FDA) to engage in the commercial manufacture, use and sale of malathion lotion 0.5 per cent. The application contains data from bioavailability or bioequivalence studies.
In Suven's ANDA, `Ovide' malathion lotion 0.5% (NDA No.01-8613) of Taro Pharma has been identified as the reference listed drug.
It also includes a certification with respect to US Patent No7,560,445 (the 445 patent), which is listed in the FDA's Electronic Orange Book of approved drug products with therapeutic equivalence evaluations for `Ovide Malathion lotion, 0.5%'.
According to the listing, the 445 patent has an expiration date of 1 February 2027.
Suven contends that in its opinion no valid and enforceable claim of the 445 patent would be infringed by the manufacture, use, or sale of the Suven ANDA product.
On the basis of Para IV certification, Taro has filed a complaint against Suven claiming that Suven's proposed Malathion product would infringe one or more claims of 445 patent.