Takeda discontinues gout med Uloric in US
Takeda has officially discontinued its gout medication Uloric in the U.S., as listed on the FDA's drug shortage database. Approved in 2009, Uloric faced declining sales due to the rise of generics, with only 3% of patients using the branded version. Takeda plans to continue distribution to wholesalers until March 31, 2026, allowing for inventory until the end of the year. The decision follows safety concerns raised by the FDA regarding cardiovascular risks associated with Uloric compared to allopurinol, leading to a boxed warning and a decline in its market position.
The journey of Takeda’s gout med Uloric—which turned rocky in recent years—has come to an end in the U.S.
This week, the medicine, first approved in 2009, was listed discontinued on the FDA’s online drug shortage database. The drug, also known as febuxostat, was cleared for chronic management of hyperuricemia—or high uric acid levels in the body—in patients with gout and was previously available in 40mg and 80mg tablets.
“As a global, R&D-driven biopharmaceutical company, we have taken this decision to help streamline our operational efficiencies and better dedicate our resources where they can provide the most value to patients,” a Takeda spokesperson told Fierce Pharma.
Since 2019, multiple generics referencing Uloric have hit the scene in the U.S., with just some 3% of patients using Takeda’s branded product versus generic competitors, the spokesperson added.
The move isn’t a total surprise, as the Japanese pharma told the FDA last year it planned to end production of branded Uloric at the end of 2024. To ease into the discontinuation, Takeda will continue to distribute Uloric to U.S. wholesalers through March 31, 2026, which should provide enough inventory for patients through the end of the year, the spokesperson said.
Uloric’s sales seem to have peaked in Takeda’s 2019 fiscal year, when the drug brought home 51.1 billion Japanese yen (then around $477 million). The following year, Takeda did not report directly on the drug’s sales, instead noting that revenue beyond its core therapeutic areas dropped 18.5%. The company blamed the issue, in part, on “off-patented products such as Uloric.”
Things started to take a turn for Uloric in 2017, when the FDA sent out a drug safety communication to the public signaling the medicine’s potential to cause increased cardiovascular events versus allopurinol—a long and widely available, generic gout drug.
Subsequently, safety flags raised in a post marketing study in 2018 prompted consumer advocacy group Public Citizen to petition the FDA to remove Uloric from the U.S. market.
Another blow struck in 2019, when the FDA revoked Uloric’s first-line treatment nod and added a boxed warning that the medication carried an increased risk of death compared to allopurinol.
Takeda did not fight the decision, with a spokesperson telling Fierce Pharma at the time that the company found the label updates “appropriate” to ensure doctors and patients had the info to make proper treatment decisions.
