An Australian pharmaceutical firm is taking on global giant Pfizer in a bid to make a generic version of a heart medication.
The patent for Pfizer's Tikosyn drug - used to prevent irregular heartbeats - doesn't expire until October 2018.
But Mayne Pharma believes its US based 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.
Under US law, 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.
But Pfizer has filed a claim in a US District Court seeking to prevent Tiger, a holding company, from gaining the right to make a generic version before the patent expires.
Wilson HTM analysts said Pfizer's legal action was not unusual.
"Pfizer has sued one of Mayne's US subsidiaries for patent infringement, which is a routine response and is standard practice when a branded drug is so challenged," it said in a client note.
It predicted approval in 2017, adding that the awarding of generic marketing rights for Tikosyn could add $US20 million ($A21.64 million) in net sales to Mayne.
Mayne said it had an agreement with a development partner to share equally the litigation costs and potential profits from selling a generic drug.
Mayne shares were two cents weaker at 76.5 cents by 1352 AEDT.
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