U.K.'s Competition and Markets Authority is accusing Actavis UK of overcharging the National Health Service for hydrocortisone tablets.
The regulator found that Actavis UK broke competition law by increasing the price of 10-milligram hydrocortisone tablets from 70 pence in April 2008 to £88 per pack by March 2016. The company was also found to have increased the price of 20-milligram hydrocortisone tablets by nearly 9,500% to £102.74 per pack by March 2016.
CMA cautioned, however, that its findings were provisional in nature and that no conclusion should be drawn at this time.
Hydrocortisone treats life-threatening conditions such as Addison's disease. Actavis UK secured rights to produce generic hydrocortisone in 2008, leaving it free from regulation.
De-branded drugs are not subject to price regulation under U.K. law.
"Prior to April 2008, the NHS spent approximately £522,000 a year on hydrocortisone tablets. By 2015, NHS spend on the tablets had risen to £70 million a year," the regulator said in a statement.
Teva Pharmaceutical Industries Ltd., the parent of Actavis UK, said it would defend itself against the allegations, according to media reports.