Suven Life Sciences has informed that Taro Pharma has filed suit against its ANDA 091559 in New Jersey District Court, USA. Earlier Suven has submitted ANDA No 091559 under 21 U.S.C. & 355(J), which contains data from bioavailability or bioequivalence studies, to obtain approval to engage in the commercial manufacture, use of sales of malathion lotion, 0.5 per cent.

The above ANDA identifies Ovide malathion lotion 0.5 per cent (NDA No 01-8613) of Taro Pharma with US Patent No 7560445. This patent is listed as having an expiration date of February 1, 2027.

Suven has certified that, in the opinion of Suven and to the best of its knowledge, no valid and enforceable claim of the patent 7560445 will be infringed by the manufacture, use, or sale of the Suven ANDA product. Pursuant to 21 U.S.C. & 355(j)(2)(b)(iv), a detailed statement of the factual and legal bases upon which Suven based its Paragraph IV certification has been submitted and the same has been informed to Taro Phama. This information is supplied for the sole purpose of complying with the above-referenced statutes.

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 7560445 patent.