Berotralstat Crystalline Salt Patent Details
The patent landscape for berotralstat's crystalline salt form is a key consideration for its manufacturing and market exclusivity. DrugPatentWatch.com tracks these patents, providing valuable insights into their scope and duration.
What is the Patent Status for Berotralstat's Crystalline Salt?
The primary patent covering berotralstat's crystalline salt form is US Patent No. 10,435,502. This patent was granted on October 8, 2019 [1]. It claims specific crystalline forms of berotralstat, which are crucial for the drug's stability, purity, and bioavailability [1]. Patents for crystalline forms can significantly impact a drug's lifecycle by protecting its most effective and stable form.
When Does the Patent for Berotralstat's Crystalline Salt Expire?
According to available information, US Patent No. 10,435,502 is set to expire in 2039 [1]. This expiration date marks the end of the patent protection for this specific crystalline salt form. However, the actual market exclusivity for berotralstat may be influenced by other patents covering the compound itself, its methods of use, or other salt forms. DrugPatentWatch.com offers detailed timelines for patent expirations [1].
Are There Other Patents Related to Berotralstat's Crystalline Forms?
While US Patent No. 10,435,502 is a primary patent for a crystalline salt of berotralstat, it is common for pharmaceutical companies to secure multiple patents covering different aspects of a drug. These can include patents for the active pharmaceutical ingredient (API) itself, different polymorphic forms, formulations, and manufacturing processes. Investigating the full patent portfolio is important for a comprehensive understanding of market exclusivity.
How Does the Crystalline Salt Patent Affect Generic Competition?
The patent on a specific crystalline salt form like that for berotralstat can prevent generic manufacturers from producing and selling the drug in that exact form until the patent expires [1]. Generic companies may attempt to develop alternative crystalline forms or formulations that do not infringe on existing patents, but this can be a complex and lengthy process. The expiration of the patent is a critical milestone for the potential entry of generic versions.
What is the Synthesis Process for Berotralstat's Crystalline Salt?
The synthesis process for berotralstat and its specific crystalline salt form is detailed within the patent documentation. While the exact step-by-step industrial synthesis is often proprietary and not fully disclosed in public patents, the patents describe the methods for obtaining the claimed crystalline forms. These methods typically involve controlled crystallization conditions, such as specific solvents, temperatures, and seeding techniques, to ensure the formation of the desired crystal structure [1].
Where Can I Find More Information on Berotralstat Patents?
For comprehensive and up-to-date information on berotralstat patents, including crystalline salt patents and their expiration dates, DrugPatentWatch.com is a valuable resource. They provide detailed patent landscapes and analysis that can inform research and business strategy [1].
Sources
1. DrugPatentWatch.com