Federal judge says Lilly cannot stop sales of generic versions of Axiron

Axiron Federal judge says Lilly cannot stop sales of generic versions of Axiron Eli Lilly and Co. and its partner Acrux cannot stop competitors from selling generic versions of its testosterone treatment Axiron, a federal judge in Indianapolis ruled.

Melbourne, Australia-based Acrux developed Axiron. Lilly, based in Indianapolis, has the exclusive rights to market the drug. The hormone replacement therapy product generated $29.3 million in global sales for the second quarter of 2016.

The two companies filed a lawsuit last summer against a group of generic drugmakers including Perrigo Co., Actavis Laboratories and Lupin Pharmaceuticals, for infringing on their patent. U.S. Judge Sarah Evans Barker concluded that a formulation patent originally granted for the drug was invalidated and therefore could not be infringed upon.

Acrux issued a statement that the ruling would cause a “material decline” in net sales and royalities, which made up 84 percent of Acrux’s sales for the first half of 2016.

Patent fights are not the only legal battles manufacturers of testosterone treatments are facing.

Testosterone replacement therapies are intended to increase testosterone levels in men with hypogonadism, a condition in which the body does not produce enough of the hormone. Drugmakers heavily promoted testosterone treatments in the U.S. for “Low-T,” a condition they say could cause low sex drive, weight gain and muscle loss. The ads resulted in skyrocketing sales of testosterone treatments in the U.S.

The so-called Fountain of Youth did not fare well for all patients. Studies began to surface that testosterone therapy could increase the risk of life threatening cardiovascular events including heart attacks, strokes and death.

The Food and Drug Administration (FDA) conducted a safety review and added warnings about the increased cardiovascular risk to the labels of testosterone products. The agency also required tighter prescribing of the products in an effort to curb over prescribing.

Source: Indianapolis Business Journal