Natco Pharma seeks nod for generic copy of Taiho’s cancer drug Lonsurf

Lonsurf had US sales of $150 million in 2018

India-based Natco Pharma has filed an application with the US Food and Drug Administration seeking permission to market a generic copy of Lonsurf, a drug approved just four years ago to treat colorectal/gastric cancers.

The application has been filed with a ‘Paragraph IV’ declaration.

Such a declaration essentially states that the filer, Natco, believes that it should be allowed to market the drug even though it is protected by a patent, since, in its opinion, the patent is either invalid, unenforceable, or will not be infringed by the generic product.

The brand owner, Taiho Oncology, will get 45 days to file a patent infringement suit against Natco. If it files such a suit, FDA approval to market the generic drug is generally postponed for 30 months unless the patent expires or is judged to be invalid or not infringed before that time.

Under FDA rules, the first company or companies to submit an application that is determined by the agency to be “substantially complete” upon submission and contains a paragraph IV certification to at least one of the patents listed in FDA’s Orange Book is generally eligible for the exclusive right to market the generic drug for 180 days.

In a statement, Natco said it believes “that it is one of the first ANDA (generic application) filers for the product and could be eligible for 180 days exclusivity under certain circumstances.”

Lonsurf, or trifluridine/tipiracil, is a combination drug that is used as a third- or fourth-line treatment of metastatic colorectal cancer, after chemotherapy and targeted therapeutics have failed.

Since the synthesis of 5-fluorouracil (5-FU) in 1957, fluoropyrimidines have been used to treat many types of cancer.

Lonsurf has sales of $150 million for 2018 in the US, as per market tracker IQVIA.

Trifluridine/tipiracil was approved by the U.S. FDA in September 2015, and by the European Medicines Agency in April 2016.