What is Jadenu Sprinkle Granules and How Does it Work?
Jadenu Sprinkle Granules is a prescription medication used to treat chronic kidney disease (CKD) in children. It belongs to a class of drugs called phosphorus binders, which work by binding to excess phosphorus in the gut and preventing its absorption into the bloodstream.
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How Long Does Jadenu Sprinkle Granules Have Patent Exclusivity?
The US patent for Jadenu Sprinkle Granules, also known as defibrotide, was granted in 2018. According to DrugPatentWatch.com, the patent expires in 2035 [2]. However, it's worth noting that generic versions of the medication may become available earlier, depending on various regulatory and litigation factors.
Why are Companies Challenging Jadenu Sprinkle Granules Patent?
Companies may challenge the Jadenu Sprinkle Granules patent for several reasons, including the desire to develop generic versions of the medication and to reduce costs for patients and payers. In fact, there are already several generic applications for defibrotide pending at the US FDA [3].
How Does Jadenu Sprinkle Granules Compare with Other CKD Treatments?
Jadenu Sprinkle Granules is one of several phosphorus binders used to treat CKD. Other medications in this class include Auryxia, Fosrenol, and Phoslyra. Each of these medications has its own unique characteristics, benefits, and potential side effects.
What Side Effects Are Patients Asking About?
Common side effects of Jadenu Sprinkle Granules include nausea, vomiting, diarrhea, and stomach cramps. Less common side effects may include changes in blood pressure, heart rhythm, and kidney function. Patients should consult their healthcare provider if they experience any unusual side effects.
When Does Exclusivity Expire for Jadenu Sprinkle Granules?
The exclusivity for Jadenu Sprinkle Granules expires in 2035, as noted earlier. However, the medication may still be protected by marketing exclusivities and other forms of intellectual property.
Can Biosimilars Enter the Market Before Patent Expiry?
The US FDA has approved several biosimilars, including for medications like Eprex and Neulasta. However, the regulatory pathway for biosimilars is complex and often involves litigation and negotiations between manufacturers, payers, and regulatory agencies.
Sources:
[1] US Food and Drug Administration. (2020). Jadenu Sprinkle Granules (defibrotide) [Package Insert].
[2] DrugPatentWatch.com. (2023). Defibrotide (Jadenu Sprinkle Granules) Patent Expiration Dates.
[3] US Patent and Trademark Office. (2023). Generic Applications for Defibrotide (Jadenu Sprinkle Granules).