Uloric manufacturers are the companies that designed, make, market, and sell the drug Uloric, a prescription drug that treats gout. While Uloric was originally developed by the Japanese company Teijin Pharma, it has been marketed in the United States by Takeda Pharmaceutical Co.
- 1. Takeda Pharmaceutical Company
- 2. The role of Teijin Pharma in Uloric
- 3. Approval of Uloric in the U.S.
- 4. Takeda’s patent protection for Uloric
1. Takeda Pharmaceutical Company
Takeda Pharmaceutical Co. is the company that markets and sells Uloric, a prescription treatment for gout, in the United States.
Takeda Pharmaceutical was originally founded in 1781 as a seller of medicinal herbs in Osaka, Japan. It was incorporated as a company in 1925, but did not factor much in the U.S. markets until 1977. In that year, Takeda partnered with the American pharmaceutical company Abbott Laboratories to form TAP Pharmaceuticals. TAP Pharmaceuticals was a useful way for Takeda to bring Japanese-made drugs to the U.S. markets.
Through TAP Pharmaceuticals, Takeda introduced several drugs to the United States, like:
- Cefonomil, an antibiotic,
- Cefmax, an antibiotic,
- The sleeping pill Estazolam, and
- Leuprorelin, also known as Lupron, a hormone that can treat certain kinds of cancers and is used in hormonal therapy.
The TAP Pharmaceuticals partnership with Abbott Labs continued until 2008, when Takeda and Abbott agreed that Takeda would subsume TAP Pharmaceuticals. TAP Pharmaceuticals then became a wholly-owned subsidiary that was merged into Takeda Pharmaceuticals North America, Inc. This new company would become Takeda’s major presence in America.
In total, Takeda Pharmaceutical Co. has more than 30,000 employees. Many of them work in Japan, where their global headquarters is located in downtown Tokyo.
Takeda Pharmaceutical Co. also maintains a strong presence in the U.S. Approximately 5,000 of its employees work in the U.S. Many of them used to work in Takeda’s primary U.S. office in Deerfield, Illinois, just outside of Chicago. However, that office closed in September, 2018, moving operations to Takeda’s office in Boston.1
Takeda Pharmaceutical is the largest pharmaceutical company in Asia, and one of the largest in the world. It regularly makes around $16 billion in revenue per year.2
However, Takeda has also faced serious lawsuits in recent years for its drugs. The most prominent lawsuit has been a failure to warn lawsuit over its diabetes pill, Actos. Actos had been linked to a sharp increase in the risk for cancer, but there was evidence that Takeda covered up evidence of the risks.3 Takeda settled an estimated 9,000 claims of bladder cancer for $2.37 billion in 2015.4
2. The role of Teijin Pharma in Uloric
Uloric, the brand name for the drug febuxostat, was first synthesized in Japan in 1998 by the pharmaceutical company Teijin Pharma. However, Teijin Pharma is not responsible for the sale of Uloric in the United States.
Teijin had noted that the existing drug that treated gout was allopurinol, brand name Zyloprim, which had been around since 1966 and was available generically. Zyloprim was known to cause allergic reactions and hypersensitivity in patients. Some of these conditions could have potentially fatal dermatological consequences, like toxic epidermal necrosis and Stevens-Johnson syndrome.5 Additionally, small missteps in dosing allopurinol can have devastating consequences, especially when patients have kidney problems.6
Sensing a hole in the market, Teijin Pharma created the drug that would become Uloric. Like allopurinol, Uloric works by cutting down the uric acid levels in the blood, preventing the acid buildups in joints that lead to gout. However, Uloric does not carry the hypersensitivity risks, and is easier to dose safely.
Soon after developing the drug, Teijin joined forces with TAP Pharmaceuticals to market Uloric in America.
When the TAP Pharmaceuticals partnership dissolved in 2008, Teijin continued with Takeda to sell Uloric in the U.S.
3. Approval of Uloric in the U.S.
Takeda Pharmaceutical Co. won approval for Uloric by the U.S. Food and Drug Administration (FDA) in 2009.
Importantly, the FDA’s initial approval of Uloric was only for 40 milligram and 80 milligram doses of Uloric.7 The requested approval had been for 80 milligram and 120 milligram versions of the drug, but the FDA was wary of Uloric’s side effects, which could lead to heart problems. The FDA also included a warning in its approval of Uloric for potential cardiovascular events.8
Additionally, as a condition of approval, the FDA required Takeda Pharmaceuticals to conduct a postmarket clinical trial that focused on Uloric’s threat to a patient’s heart condition.9 The results of this trial would lead the FDA to add a boxed warning to Uloric’s label.
4. Takeda’s patent protection for Uloric
Takeda Pharmaceuticals has patent protection for Uloric until June, 2019. Until that point, only Takeda can sell the chemical composition that makes up its drug, Uloric.
Pharmaceutical companies in the United States are incentivized to develop new drugs by the 20-year monopoly that they get when they patent a new drug. During those 20 years, only the maker of the drug can sell it in America. Other companies infringe on the patent and can face legal consequences if they copy the drug and sell it as a generic version.
Once that 20-year period expires, though, other companies are free to sell their own versions of the drug. These are known as generics. The price competition that these generics create means that the cost of the drug drops precipitously as soon as the drug’s patent protection ends. Until the 20 years expire, though, the drug maker can charge whatever price it wants, because there are no competitors in the market.
Until Uloric’s patent protection expires, though, Takeda Pharmaceuticals is the only company that manufactures and sells Uloric. All of the people who have taken Uloric up until that time will have taken a dose of the febuxostat drug that was made by Takeda.
This is good news for people who have been hurt by Uloric’s side effects – particularly its increased risk of a severe cardiovascular event like a heart attack or stroke. Unlike with many other defective drug cases, there is no need to find out which one of a variety of drug companies was ultimately responsible for your injuries, yet.
Legal References:
- Lisa Schencker, “Takeda’s U.S. headquarters in Deerfield, where 1,000 people work, to close,” Chicago Tribune (September 11, 2018).
- See Takeda Press Release, “Takeda reports FY2017 full year results and issues FY2018 guidance,” (May 14, 2018).
- See H Tang, W Shi, S Fu, T Wang, S Zhai, Y Song, Han J, “Pioglitazone and bladder cancer risk: a systematic review and meta‐analysis,” Cancer Medicine 7(4): 1070-80 (April 2018).
- Andrew Pollack, “Takeda Agrees to Pay $2.4 Billion to Settle Suits Over Cancer Risk of Actos,” The New York Times (April 28, 2015).
- Chung WH, Wang CW, Dao RL, “Severe cutaneous adverse drug reactions,” Journal of Dermatology 43(7):758-66 (July 2016).
- See Dalbeth N, Stamp L, “Allopurinol Dosing in Renal Impairment: Walking the Tightrope Between Adequate Urate Lowering and Adverse Events,” Seminars in Dialysis 20(5):391-5 (September/October 2007).
- FDA Approval Letter for Uloric – 2009.
- FDA Warning Label for Uloric – 2009.
- See note 7.