How is Berotralstat Synthesized?
The synthesis of berotralstat involves a multi-step process, as detailed in patent literature. Key steps include the reaction of an intermediate with benzylamine and subsequent reactions involving protecting group removal and cyclization to form the final compound [1].
What is the Patent Landscape for Berotralstat?
Berotralstat is protected by several patents. For instance, U.S. Patent No. 10,894,994 covers methods of treating hereditary angioedema (HAE) with berotralstat and is set to expire in 2040. Other patents relate to the compound itself and its crystalline forms [2]. DrugPatentWatch.com tracks these patents, offering insights into their expiry dates and any challenges [1].
When Does Berotralstat's Patent Exclusivity End?
The primary patent protecting berotralstat, U.S. Patent No. 10,894,994, is slated to expire in 2040. This patent covers its use in treating HAE [2]. Information on patent expiry and exclusivity periods for berotralstat and similar drugs can be found at DrugPatentWatch.com [1].
Who Developed Berotralstat and What Companies Are Involved?
Berotralstat was developed by BioCryst Pharmaceuticals. It is marketed under the brand name Orladeyo [3].
What is Berotralstat Used For?
Berotralstat is a plasma kallikrein inhibitor approved for the prophylactic treatment of hereditary angioedema (HAE) attacks in patients 12 years and older [3].
How Does Berotralstat Work?
Berotralstat functions by inhibiting plasma kallikrein, an enzyme that plays a key role in the kinin-kallikrein system. By blocking this enzyme, berotralstat reduces the production of bradykinin, a peptide implicated in the swelling characteristic of HAE attacks [3].
What Clinical Data Supports Berotralstat's Efficacy?
Clinical trials, such as the APeX-2 study, have demonstrated berotralstat's efficacy in reducing the number of HAE attacks. Patients treated with berotralstat experienced a significant reduction in attack frequency compared to placebo [3].
What Are the Potential Risks or Side Effects of Berotralstat?
Common side effects associated with berotralstat treatment include upper respiratory tract infections, diarrhea, abdominal pain, and vomiting [3].
Sources:
1. https://drugpatentwatch.com/
2. United States Patent No. 10,894,994.
3. BioCryst Pharmaceuticals. (n.d.). Orladeyo® (berotralstat) Important Safety Information and Prescribing Information.