Endo, Bayer Win Patent Suit for Testosterone Drug

Feb. 15, 2017

Custopharm Inc., which filed an abbreviated new drug application (ANDA) for FDA approval to make a generic version of Endo International's testosterone drug, did not prove the patents on Aveed were invalid, according to a Bloomberg article.

Thanks to Judge Sue L. Robinson of the U.S. District Court for the District of Delaware's ruling, Aveed (testosterone undecanoate) won’t have generic competitors until March 14, 2027, when the second of the challenged patents in the litigation expires.

Aveed competes with other testosterone replacement products, including AbbVie’s AndroGel and Eli Lilly’s Axiron, the story said. But unlike some other testosterone products that are patches or gels, Aveed is implanted under the skin and provides replacement testosterone for up to three months.