Court Rules Takeda is Liable to Abbvie for Lupron Depot Damages

A Delaware court ruled Wednesday that Takeda Pharmaceutical is liable for damages to AbbVie for failing to supply its hormone therapy Lupron Depot (leuprolide acetate for depot suspension) according to the contract.

Takeda has been unable to supply the drug — which is indicated to treat endometriosis, uterine fibroids, premature puberty and prostate cancer — to AbbVie Endocrine, an AbbVie subsidiary, since an FDA inspection of its plant in Hikari, Japan, in 2019 turned up problems.

The problems at the plant began in late 2019. First, on or around Oct. 28, 2019, “an autoclave at the Hikari facility used for sterilization purposes critical to the production of leuprorelin products, including Lupron, failed its annual requalification test,” said Delaware Chancery Court Vice Chancellor Sam Glasscock in his court order.

The FDA inspected the plant in November and issued a Form 483. This was followed in March 2020 by an Official Action Indicated letter from the agency, saying its investigators had observed an “unacceptable state of compliance” with current good manufacturing practices during the inspection.