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Drug Sales Trends for ULORIC
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Annual Sales Revenues and Units Sold for ULORIC
| Drug Name | Revenues (USD) | Units | Year |
|---|---|---|---|
| ULORIC | ⤷ Try for Free | ⤷ Try for Free | 2021 |
| ULORIC | ⤷ Try for Free | ⤷ Try for Free | 2020 |
| ULORIC | ⤷ Try for Free | ⤷ Try for Free | 2019 |
| >Drug Name | >Revenues (USD) | >Units | >Year |
Market Analysis and Sales Projections for Uloric (Febuxostat)
Introduction to Uloric
Uloric, also known as febuxostat, is a xanthine oxidase inhibitor used for the chronic management of hyperuricemia in adult patients with gout. It was first approved by the FDA in 2009, marking the first new gout treatment in over 40 years[1].
Market Position and Approval History
When Uloric was initially approved, it was seen as a significant milestone in the treatment of gout, especially given the large patient population of approximately 5.1 million in the U.S.[1]. However, the approval process was not without its challenges. The FDA initially rejected the higher dosages (80-mg and 120-mg) due to concerns over cardiovascular risks, ultimately approving only the 40-mg and 80-mg dosages[1].
Safety Concerns and Regulatory Updates
In 2019, the FDA conducted a postmarketing safety clinical trial that revealed an increased risk of heart-related deaths and death from all causes associated with Uloric compared to allopurinol, another commonly used gout medication. This led to the addition of a boxed warning on Uloric's label and the limitation of its use to patients who have failed or do not tolerate allopurinol[2][4].
Impact on Sales and Market Share
Despite the initial growth and positive reception, the safety concerns and subsequent regulatory actions have had a significant impact on Uloric's sales and market share. Prior to the safety updates, Uloric had been one of the growing drugs in Takeda’s portfolio, with sales of 40.5 billion Japanese yen ($366 million) in the nine months ended in December 2018, up 15.7% year over year[2].
However, the boxed warning and the restriction to second-line use have likely curtailed its growth. The drug's sales have been affected as it is now reserved for a smaller population of patients who cannot tolerate or have failed allopurinol[2][4].
Current Market and Sales Figures
As of recent data, the generic version of Uloric, approved by the FDA for Lupin Limited, indicates that the estimated annual sales of Febuxostat Tablets (the generic equivalent of Uloric) were around $27 million in the U.S. as of November 2023[5].
Market Size and Growth Projections for Hyperuricemia Drugs
The hyperuricemia drugs market, which includes Uloric, is expected to grow significantly. The market size was valued at USD 5.08 billion in 2023 and is projected to grow at a CAGR of 8.52% from 2024 to 2030, reaching nearly USD 9 billion by 2030[3].
Competitive Landscape
The hyperuricemia drugs market is competitive, with various types of drugs including nonsteroidal anti-inflammatory drugs, xanthine oxidase inhibitors (like Uloric), selective uric acid reabsorption inhibitors (SURI), and uricosuric agents. Uloric, despite its safety concerns, remains a significant player due to its efficacy in lowering uric acid levels in patients with gout[3].
Sales Projections for Uloric
Given the current regulatory environment and the competitive landscape, the sales projections for Uloric are likely to be modest. Here are some key points to consider:
- Restricted Use: The limitation of Uloric to second-line treatment will cap its potential market share and sales growth.
- Generic Competition: The approval of generic versions, such as Lupin’s Febuxostat Tablets, will further erode the market share of the branded version[5].
- Market Growth: Despite these challenges, the overall growth of the hyperuricemia drugs market could still benefit Uloric to some extent, though its share will be smaller compared to other treatments.
Key Takeaways
- Uloric was the first new gout treatment approved in over 40 years but faced significant regulatory hurdles.
- Safety concerns led to a boxed warning and restricted use, impacting sales.
- The drug remains a part of the growing hyperuricemia drugs market but with limited growth potential.
- Generic competition will further affect the sales of the branded version.
FAQs
Q: What is Uloric used for? A: Uloric (febuxostat) is used for the chronic management of hyperuricemia in adult patients with gout.
Q: Why was Uloric's approval process delayed? A: The approval process was delayed due to FDA concerns over cardiovascular risks associated with higher dosages of the drug.
Q: What safety concerns have been associated with Uloric? A: Uloric has been associated with an increased risk of heart-related deaths and death from all causes compared to allopurinol.
Q: How has the FDA's safety update affected Uloric's use? A: The FDA has limited Uloric’s use to patients who have failed or do not tolerate allopurinol, and added a boxed warning to its label.
Q: What is the current sales figure for Uloric? A: As of November 2023, the estimated annual sales of the generic equivalent of Uloric were around $27 million in the U.S.
Sources
- SP Global Market Intelligence: FDA Grants its Final Nod to Takeda's Gout Treatment Uloric.
- FiercePharma: Takeda gout drug Uloric loses first-line approval after FDA confirms safety risks.
- Maximize Market Research: Hyperuricemia Drugs Market: Growth, Size, forecast, Statistics.
- FDA: FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat).
- Lupin: Lupin Receives Approval from U.S. FDA for Febuxostat Tablets.
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