Watson Pharmaceuticals is dragging the US Food and Drug Administration to court over its refusal to give the firm shared exclusivity for a generic version of Takeda's diabetes blockbuster Actos.
Watson had planned to roll out its copycat of Actos (pioglitazone) - which generates annual sales of around $2.7 billion - on August 17, after having reached a legal settlement agreement with Takeda back in March under which it gained US patents for the drug, but this could now be delayed substantially.
The company believes that the FDA has "improperly denied" it 180 days shared exclusivity, and that as a result of this decision, Watson's abbreviated new drug application (ANDA) could be delayed for up to six months.
Consequently, the firm said it filed suit, after communications with the regulator about its ANDA "failed to resolve the dispute and permit a timely launch".
The action may cause "potential harm to consumers who may face constraints on supply as a result of this action," warned Paul Bisaro, Watson's president and chief executive, noting that the firm believes it has "sound arguments that refute FDA's position and will seek the court's intervention to enable approval".
Watson was quick to reassure investors that even if the FDA fails to timely approve its ANDA for generic Actos, it remains on track to hit most of its full-year forecast "due to a recent favorable update from the FDA related to another product and improved market conditions for certain products within the US generics business".