18 November 2014 | News | By BioSpectrum Bureau
Pfizer sues Mayne pharma's US arm
The patent for Tikosyn expires in 2018
Singapore: Australia-based drug giant, Mayne pharma has reportedly filed an application seeking rights to produce and market the generic version of Pfizer's heart medication-Tikosyn, used to prevent irregular heartbeats.
The patent for Tikosyn does not expire until 2018. Mayne pharma said that its US subsidiary Tiger Pharmaceuticals LLC, is the first company to file a bid, with the US Food and Drug Administration, for the rights to manufacture a generic version of the Pfizer product.
According to the US patent laws, a rival pharmaceutical company can apply for an abbreviated new drug application, which gives them the right to be the exclusive generic marketer for 180 days. However, Pfizer has now filed a claim with the US district seeking to prevent Tiger from gaining the right to formulate a generic version before the patent expires.
It is estimated that approval of generic version of Tikosyn will add nearly $20 million to Mayne's net sales.