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Adamis Pharmaceuticals seeks US FDA approval for Cialis copycat

Adamis Pharmaceuticals Corp. is seeking U.S. approval for tadalafil, joining the list of pharmaceutical companies looking to market a copycat version of Eli Lilly and Co.'s erectile dysfunction drug Cialis.

The company filed a new drug application with the U.S. Food and Drug Administration, seeking approval for its medicine.

Adamis President and CEO Dennis Carlo said the company's tadalafil product candidate is well-positioned to compete in the large, multibillion-dollar erectile dysfunction market.

Earlier this year, Teva Pharmaceutical Industries Ltd. became the first company to file an application with the U.S. Food and Drug Administration for a generic version of Cialis, which grants it six months of market exclusivity once its product is approved.

Market exclusivity for Cialis ended Sept. 27, as opposed to April 26, 2020, after Lilly entered a settlement with certain manufacturers looking to introduce a generic version of the drug.

Cialis had annual sales of about $1.93 billion in the U.S. as of July 2018, according to IQVIA data.