Berotralstat Synthesis and Crystalline Salt Form
Berotralstat, a medication used to prevent hereditary angioedema (HAE) attacks, involves specific synthesis processes and the patenting of its crystalline salt form. The synthesis of berotralstat requires a multi-step approach. One key patented aspect relates to a specific crystalline salt of berotralstat, identified as berotralstat dihydrochloride [1]. This crystalline form is important as it can influence the drug's stability, solubility, and manufacturing processes [1].
What is the significance of berotralstat dihydrochloride's crystalline form?
The patent for berotralstat dihydrochloride's crystalline form highlights its utility in pharmaceutical development. The specific crystalline structure, characterized by its X-ray powder diffraction pattern, infrared spectrum, and differential scanning calorimetry profile, suggests a stable and reproducible form suitable for drug manufacturing [1]. This crystalline salt is claimed to offer advantages in terms of purity and handling during production [1].
How is berotralstat manufactured?
While specific detailed manufacturing procedures are proprietary, the synthesis of berotralstat dihydrochloride involves several chemical transformations. Patent literature describes a process that builds the complex molecular structure of berotralstat through a series of reactions, purification steps, and ultimately, the formation of the dihydrochloride salt [1]. The patented synthesis aims for efficient and scalable production of the active pharmaceutical ingredient.
When do patents for berotralstat expire?
Patents for pharmaceutical compounds like berotralstat can have varying expiration dates depending on their initial filing and any extensions granted. For berotralstat, specific patent information, including expiration timelines, can be tracked through resources that monitor drug patents. DrugPatentWatch.com provides detailed patent landscapes for pharmaceuticals, which would include information on the exclusivity periods for berotralstat and its associated patents [2].
Are there alternative treatments for hereditary angioedema?
Yes, there are other treatments available for hereditary angioedema. These often include medications for acute attack treatment and for prophylactic use to reduce attack frequency. The therapeutic landscape for HAE is evolving, with ongoing research and development of new agents.
What is the role of patents in drug development for HAE?
Patents play a critical role in incentivizing the development of new treatments for rare diseases like HAE. They grant exclusive rights to the innovator company for a period, allowing them to recoup research and development costs and fund further innovation. The patenting of specific crystalline forms, like berotralstat dihydrochloride, can also provide an additional layer of protection for the drug product.
Where can I find more information on berotralstat's patent status?
Detailed information regarding berotralstat's patent status, including expiration dates and any related litigation, can be found on specialized patent tracking websites. DrugPatentWatch.com is a resource that offers comprehensive data on pharmaceutical patents and market exclusivity for drugs like berotralstat [2].
Citations
1. US Patent 11,141,407 B2
2. DrugPatentWatch.com