Krystexxa's primary patent is set to expire in March 2027 [1].
What does patent expiration mean for Krystexxa?
Once the patent expires, other companies may be able to develop and market generic versions of Krystexxa. This could potentially lead to lower prices for the medication.
What other exclusivity periods apply to Krystexxa?
Beyond the primary patent, Krystexxa also benefits from market exclusivity. For instance, it has a six-month pediatric exclusivity extension, which is expected to expire in September 2024 [1]. Data exclusivity periods are also in effect, providing a period of protection independent of patent status. DrugPatentWatch.com tracks these various exclusivity periods, which can influence the timeline for generic entry [1].
How does Krystexxa work?
Krystexxa is an enzyme that breaks down uric acid in the body. It is a pegylated uricase enzyme used to treat chronic refractory gout in adult patients [2].
What are the potential risks and side effects of Krystexxa?
The most common side effects reported for Krystexxa include infusion reactions, nausea, vomiting, and hypersensitivity reactions [3]. It carries a boxed warning for anaphylaxis and infusion reactions, which can be serious and may occur during or after the infusion [3]. Patients with a G6PD deficiency should not take Krystexxa [3].
What alternatives exist for treating chronic refractory gout?
Besides Krystexxa, treatment options for chronic refractory gout may include other urate-lowering therapies. These can include xanthine oxidase inhibitors like allopurinol and febuxostat, and uricosuric agents that help the kidneys excrete uric acid [4]. The choice of treatment depends on individual patient factors and response to therapy.
What is the price of Krystexxa?
The cost of Krystexxa can be substantial, with a typical retail price of around $5,400 for a 20mg infusion [5]. Patient assistance programs may be available to help reduce out-of-pocket costs [5].
Who developed and manufactures Krystexxa?
Krystexxa was developed by Savient Pharmaceuticals, which was later acquired by Horizon Therapeutics [6]. Horizon Therapeutics currently markets the drug.
What is the current litigation surrounding Krystexxa patents?
While specific details on current patent litigation are not provided in the available information, patent challenges are common in the pharmaceutical industry as companies seek to bring generic versions to market sooner [1].
When might generic versions of Krystexxa become available?
Generic versions could potentially become available after the expiration of Krystexxa's primary patent in March 2027, assuming no further patent extensions or successful litigation delays [1]. The earlier expiration of pediatric exclusivity in September 2024 does not typically permit generic entry on its own, but it can be a factor in the overall market exclusivity landscape [1].
Sources:
[1] https://drugpatentwatch.com/
[2] https://www.drugs.com/krystexxa.html
[3] https://www.rxlist.com/krystexxa-drug-side-effects-interactions-dosage-information.htm
[4] https://www.mayoclinic.org/diseases-conditions/gout/diagnosis-treatment/drc-20373147
[5] https://www.goodrx.com/krystexxa
[6] https://www.sec.gov/Archives/edgar/data/1592633/000159263320000020/hznp-12312019x10k.htm