(Reuters) - British drugmaker Indivior said on Wednesday its 2018 revenue and adjusted net income would come in below its previous forecast, hurt by the launch of generic versions of its bestselling opioid addiction treatment in the United States.
India’s Dr.Reddy’s Laboratories (REDY.NS) and U.S.-based Mylan NV (MYL.O) received approval from the Food and Drug Administration (FDA) last month to launch a generic version of Suboxone Film, which generates 80 percent of Indivior’s revenue.
The company said its earlier guidance of $1.13 billion to $1.17 billion in 2018 net revenue and $280 million to $320 million adjusted net income is no longer valid as it faces market share loss of Suboxone Film and slower early uptake levels of its new drug, Sublocade.
Sublocade is a once-a-month injectable drug to suppress opioid craving, launched in the United States in February.
Suboxone Film, which is placed under the tongue to suppress cravings, recorded an accelerated market share loss, shedding two-and-half percentage points to 52 percent, in its most recent weekly data, the company said.
Indivior currently estimates 2018 net revenue impact from this level of market share loss to be $25 million.
Indivior was forced to file an injunction last month against the FDA’s decision, but got a breather after a U.S. court issued a restraining order, blocking Dr. Reddy’s from selling a generic version, until the end of June.
The company had earlier warned that the Dr. Reddy’s launch could result in a rapid and material loss of U.S. market share for Suboxone Film.
Reporting by Justin George Varghese in Bengaluru; Editing by Amrutha Gayathri