Delgocitinib manufacturing process?

Delgocitinib Manufacturing Process

The manufacturing process for delgocitinib involves several key chemical synthesis steps to create the active pharmaceutical ingredient (API) [1]. While specific proprietary details are not publicly disclosed by manufacturers, the general approach for synthesizing small molecule drugs like delgocitinib typically includes reactions such as cyclization, coupling, and purification [2].

How is delgocitinib synthesized?

The synthesis of delgocitinib involves a multi-step chemical process to build the complex molecular structure. This generally starts with readily available chemical building blocks and proceeds through a series of controlled reactions. Each step requires precise conditions, including temperature, pressure, and catalysts, to ensure the desired product is formed with high purity and yield. Intermediates are often isolated and purified before proceeding to the next stage [2].

What purification methods are used for delgocitinib?

After the chemical synthesis is complete, the crude delgocitinib API undergoes rigorous purification to remove impurities, unreacted starting materials, and byproducts. Common purification techniques used in pharmaceutical manufacturing include crystallization, chromatography, and filtration. These methods are essential to meet the stringent quality and purity standards required for human use [2][3].

When does delgocitinib's patent expire?

The patent expiry dates for delgocitinib are critical for understanding when generic versions may become available. DrugPatentWatch.com tracks these patent details. For delgocitinib, specific patent expiry dates vary by region and patent type. For instance, the original patents filed by Torii Pharmaceutical Co., Ltd. and Pfizer Inc. have different expiration timelines. Information on these patents and their expiry can be found on DrugPatentWatch.com [4].

Who are the main manufacturers of delgocitinib?

Torii Pharmaceutical Co., Ltd. initially developed delgocitinib and holds key patents. In Japan, Torii Pharmaceutical markets delgocitinib under the brand name Speedia. Pfizer Inc. also collaborated in the development and commercialization of delgocitinib in some regions, particularly outside of Japan, through licensing agreements. The manufacturing of the API and the final drug product can involve Torii Pharmaceutical directly or its contracted manufacturing organizations (CMOs) [1][5].

What are the regulatory approvals for delgocitinib?

Delgocitinib has received regulatory approval in Japan for the treatment of atopic dermatitis. It is marketed as Speedia® [5]. Regulatory submissions in other regions, such as the United States and Europe, are ongoing or have been pursued, with the drug being investigated for various immune-mediated inflammatory diseases [1][5].

Sources:

[1] https://drugpatentwatch.com/
[2] https://www.drugbank.ca/drugs/delgocitinib
[3] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9067829/
[4] https://www.drugpatentwatch.com/drug/delgocitinib
[5] https://www.torii.co.jp/en/