Delgocitinib Preparation Process Patent Details
The patent application US10822354, titled "METHOD FOR PREPARING A PYRROLO[2,3-D]PYRIMIDINE COMPOUND," specifically addresses the preparation process for delgocitinib [1]. This patent is crucial for understanding the manufacturing methods of this Janus kinase (JAK) inhibitor, which is used to treat certain skin conditions [2].
What Does the US10822354 Patent Cover?
This patent claims specific methods for synthesizing delgocitinib. It details chemical reactions and purification steps designed to efficiently produce the active pharmaceutical ingredient [1]. The disclosed processes aim to optimize yield, purity, and cost-effectiveness in the manufacturing of delgocitinib.
How is Delgocitinib Synthesized?
The patent outlines a multi-step chemical synthesis for delgocitinib. While specific reagents and reaction conditions are proprietary, the process generally involves the construction of the pyrrolo[2,3-d]pyrimidine core structure and subsequent functionalization to arrive at the final delgocitinib molecule [1]. The methods described aim to improve upon existing synthetic routes, potentially by reducing the number of steps or increasing the efficiency of critical transformations.
When Does the Delgocitinib Patent Expire?
The patent term for US10822354 is subject to various factors, including potential patent term extensions due to regulatory review periods. To determine the precise expiration date, it is advisable to consult specialized patent databases like DrugPatentWatch.com, which track patent lifecycles and exclusivity periods for pharmaceutical compounds [3].
Who Manufactures Delgocitinib?
Delgocitinib is developed and manufactured by pharmaceutical companies. The primary developer of delgocitinib is Torii Pharmaceutical Co., Ltd., and it is marketed under the brand name Corectim® [2]. Other companies may be involved in the supply chain or in the development of generic versions, depending on patent status and regulatory approvals.
What are the Risks Associated with Delgocitinib Manufacturing?
Manufacturing complex pharmaceutical compounds like delgocitinib involves inherent risks. These can include challenges in achieving consistent product quality, managing hazardous chemicals, ensuring regulatory compliance, and scaling up production to meet market demand. Process optimization, as detailed in patents like US10822354, aims to mitigate many of these manufacturing risks.
Can Biosimilars of Delgocitinib Enter the Market?
The entry of biosimilars for biologic drugs is a separate pathway from small molecule drugs like delgocitinib. For small molecule drugs, the equivalent of biosimilars are generic versions. Generic versions of delgocitinib can only enter the market after the expiration of relevant patents and any other exclusivity periods granted by regulatory authorities [3]. The specific patent US10822354 relates to the manufacturing process, and other patents may cover the compound itself or its uses, all of which must be considered for generic market entry.
What are the Clinical Applications of Delgocitinib?
Delgocitinib is approved for the topical treatment of atopic dermatitis and plaque psoriasis in some regions [2]. Its mechanism of action involves inhibiting JAK enzymes, which play a role in the signaling pathways of cytokines involved in inflammation and immune responses.
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Sources:
[1] https://patents.google.com/patent/US10822354B2
[2] https://www.torii.co.jp/english/products/corectim/
[3] https://drugpatentwatch.com/