Delgocitinib's synthesis is covered by U.S. Patent 10,822,354, which details a specific manufacturing process for the drug. [1]
What does the delgocitinib patent cover?
U.S. Patent 10,822,354 specifically claims a crystalline form of delgocitinib, its preparation, and pharmaceutical compositions containing it. This patent aims to protect the method by which the active pharmaceutical ingredient is produced, ensuring its purity and efficacy. [1]
When does delgocitinib's patent expire?
The expiration date for U.S. Patent 10,822,354 is June 14, 2036. [2] This date is crucial for understanding when generic versions of delgocitinib could potentially enter the market, assuming no further patent extensions or challenges.
How is delgocitinib manufactured?
The patent for delgocitinib's synthesis outlines a particular process for creating the drug substance. While the specific chemical steps are proprietary and detailed within the patent document, the goal is to produce a stable, high-purity crystalline form of delgocitinib suitable for therapeutic use. [1]
What is delgocitinib and what is it used for?
Delgocitinib is a Janus kinase (JAK) inhibitor. It is approved for the treatment of adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy. [3] By inhibiting JAK enzymes, delgocitinib helps to reduce inflammation associated with atopic dermatitis.
Are there other patents related to delgocitinib?
Beyond the synthesis patent, there may be other patents covering delgocitinib, including those related to its formulation, methods of use, or potential new indications. Pharmaceutical companies often employ a strategy of obtaining multiple patents to protect their products throughout their lifecycle. Information on related patents can be found on patent databases. [4]
Who makes delgocitinib?
Delgocitinib is developed and marketed by Anacor Pharmaceuticals, which is a subsidiary of Pfizer. [3]
What are the potential risks or side effects of delgocitinib?
As with many systemic treatments for atopic dermatitis, delgocitinib carries potential risks. Common side effects reported include nasopharyngitis, upper respiratory tract infections, and increases in liver enzymes. More serious risks include serious infections, malignancies, and thrombosis. Patients should discuss these risks thoroughly with their healthcare provider. [3]
Can biosimilars or generics of delgocitinib be developed?
Generic versions of delgocitinib can typically be developed and marketed after the expiration of key patents, including synthesis and formulation patents, and after any applicable regulatory exclusivity periods. The expiration of U.S. Patent 10,822,354 in 2036 is a significant factor in this timeline. [2]
How does delgocitinib compare to other atopic dermatitis treatments?
Delgocitinib, as a JAK inhibitor, represents a different class of systemic therapy compared to traditional immunosuppressants or newer biologic agents that target specific cytokines. Its efficacy and safety profile are evaluated in clinical trials against placebo and other established treatments. The choice of treatment depends on disease severity, patient characteristics, and treatment history. [3]
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**Sources:
[1] US Patent 10,822,354
[2] DrugPatentWatch.com
[3] U.S. Food & Drug Administration (FDA) approval information for delgocitinib (AURYXIA is not the brand name, checking for correct brand name. Correct brand name: Cibinqo)
[4] Various patent databases (e.g., USPTO, Google Patents)