Takeda Discontinues Gout Medication Uloric in the U.S. Amid Safety Concerns and Generic Competition

Takeda Pharmaceutical Company has announced the discontinuation of its gout medication Uloric (febuxostat) in the United States, marking the end of a journey that began with the drug's approval in 2009. The decision comes after years of declining sales, safety concerns, and increased generic competition.

Safety Setbacks and Regulatory Changes

Uloric's trajectory took a significant turn in 2017 when the FDA issued a drug safety communication highlighting the medication's potential to increase cardiovascular events compared to allopurinol, a widely available generic gout treatment. This was followed by a more severe blow in 2019 when the FDA revoked Uloric's first-line treatment status and added a boxed warning indicating an increased risk of death compared to allopurinol.

The safety concerns stemmed from a post-marketing study conducted in 2018, which prompted the consumer advocacy group Public Citizen to petition for Uloric's removal from the U.S. market. Takeda did not contest the FDA's decision to update the label, acknowledging the importance of providing doctors and patients with comprehensive information for making informed treatment decisions.

Market Performance and Generic Competition

Uloric's commercial performance peaked in Takeda's 2019 fiscal year, generating 51.1 billion Japanese yen (approximately $477 million at the time). However, the introduction of multiple generic versions of febuxostat in the U.S. market since 2019 has significantly eroded Uloric's market share. According to a Takeda spokesperson, only about 3% of patients were using the branded product compared to its generic counterparts.

The gradual decline in Uloric's prominence was evident in Takeda's financial reports. In the fiscal year following its peak, the company reported an 18.5% drop in revenue beyond its core therapeutic areas, partially attributing this decrease to "off-patented products such as Uloric."

Discontinuation Process and Future Availability

Takeda has officially listed Uloric as discontinued on the FDA's online drug shortage database. The company had previously informed the FDA of its intention to cease production of branded Uloric by the end of 2024. To ensure a smooth transition, Takeda plans to continue distributing Uloric to U.S. wholesalers through March 31, 2026, which is expected to provide sufficient inventory for patients through the end of that year.

A Takeda spokesperson explained the decision as part of the company's efforts to streamline operational efficiencies and better allocate resources to areas that can provide the most value to patients. This move aligns with Takeda's focus on its role as a global, R&D-driven biopharmaceutical company.

As Uloric fades from the U.S. market, patients with gout and hyperuricemia will need to consult with their healthcare providers about alternative treatment options, including generic febuxostat and other available medications for managing their condition.