What is the synthesis patent for Berotralstat?
The synthesis patent for Berotralstat, the active pharmaceutical ingredient in the hereditary angioedema (HAE) treatment Orladeyo, is held by BioCryst Pharmaceuticals. Specifically, U.S. Patent No. 9,790,254 covers the compound itself and methods of its use, including its synthesis [1]. This patent is a crucial aspect of BioCryst's intellectual property surrounding the drug.
When does the Berotralstat synthesis patent expire?
The U.S. Patent No. 9,790,254 for Berotralstat is set to expire in 2034 [2]. This expiration date is significant for potential generic manufacturers looking to enter the market.
Are there other patents covering Berotralstat?
Beyond the compound and synthesis patent, BioCryst Pharmaceuticals holds additional patents related to Berotralstat. These include patents covering methods of treating HAE with the drug and formulations [2]. For a comprehensive overview of patents related to Berotralstat, DrugPatentWatch.com can be a valuable resource [3].
What is the significance of Berotralstat's synthesis patent?
The synthesis patent for Berotralstat grants BioCryst Pharmaceuticals exclusivity for a period, preventing other companies from manufacturing or selling the drug using the patented methods. This exclusivity is vital for the company to recoup its research and development investments and profit from the drug. Upon patent expiration, generic versions of Berotralstat may become available, potentially leading to increased competition and lower prices.
How does Berotralstat work for HAE?
Berotralstat is a plasma kallikrein inhibitor. By inhibiting plasma kallikrein, it reduces the production of bradykinin, a key mediator responsible for the swelling attacks characteristic of HAE [1]. This mechanism of action is central to its therapeutic benefit.
What are the clinical data for Berotralstat?
Clinical trials have demonstrated Berotralstat's efficacy in reducing the number of HAE attacks. Studies have shown a significant reduction in monthly attack rates for patients treated with Berotralstat compared to placebo [1].
Who manufactures Berotralstat?
Berotralstat is manufactured and marketed by BioCryst Pharmaceuticals under the brand name Orladeyo [1].
Sources
1. https://www.drugpatentwatch.com/drug/berotralstat
2. https://www.drugpatentwatch.com/drug/orladeyo
3. https://www.drugpatentwatch.com/