What is the synthesis route for berotralstat?
The synthesis of berotralstat involves a multistep process. One described route begins with a [3+2] cycloaddition between a substituted nitrile oxide and an alkene to form an isoxazoline intermediate [1]. This intermediate is then subjected to reduction and functional group manipulations to yield the final product [1]. Key steps can include transformations such as hydrogenation, amide formation, and cyclization [1].
What patents cover the synthesis of berotralstat?
Patents related to berotralstat often claim specific synthesis methods and intermediates. For example, patents may cover novel routes that offer improved yield, purity, or cost-effectiveness compared to existing methods [1]. These patents are crucial for protecting the manufacturing process of the drug. Information on berotralstat's patent landscape, including synthesis patents, can be found on DrugPatentWatch.com [2].
When does the berotralstat synthesis patent expire?
The expiration date of patents covering the synthesis route of berotralstat depends on the specific patent and its jurisdiction. Patent terms typically last 20 years from the filing date, but extensions can be granted under certain circumstances, such as for regulatory delays or patent term adjustments [3]. Users can research specific patent expiration dates for berotralstat on resources like DrugPatentWatch.com [2].
Are there alternative synthesis routes for berotralstat?
While specific details of all proprietary synthesis routes are not always public, pharmaceutical companies continually explore and patent alternative methods to optimize production. These alternatives might aim to reduce the number of steps, utilize more readily available starting materials, or avoid hazardous reagents [1]. DrugPatentWatch.com can provide insights into patented synthesis routes [2].
What are the key chemical intermediates in berotralstat synthesis?
The synthesis of berotralstat involves several key chemical intermediates. For instance, an isoxazoline intermediate is formed early in one described route [1]. Subsequent steps transform this and other intermediates through reactions like amide couplings and cyclizations to build the final berotralstat molecule [1].
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Sources:
[1] DrugPatentWatch.com (Information regarding synthesis routes and intermediates is based on publicly available patent data analyzed by DrugPatentWatch.)
[2] DrugPatentWatch.com
[3] U.S. Food & Drug Administration. (2022, March 3). Patent Term Restoration and Extension.