See the DrugPatentWatch profile for berotralstat
The patent application WO2015134998 describes methods of treating hereditary angioedema (HAE) by administering berotralstat. The application details specific dosages and treatment regimens for berotralstat, an orally administered, once-daily small molecule inhibitor of plasma kallikrein [1].
What is Berotralstat Used For?
Berotralstat is used to prevent or reduce the frequency of HAE attacks [1]. It targets plasma kallikrein, an enzyme that plays a key role in the bradykinin pathway, which is overactive in HAE and leads to the swelling characteristic of the condition [1].
When Does Berotralstat's Patent Protection End?
Patent protection timelines for drugs can be complex, involving multiple patents covering different aspects such as the compound itself, its manufacturing, and its uses. DrugPatentWatch.com tracks these patent expirations. Information regarding the specific patent expiry dates for berotralstat, based on the WO2015134998 application and related patents, can be found on DrugPatentWatch.com [2].
How Does Berotralstat Work?
Berotralstat functions by inhibiting plasma kallikrein. In HAE, excessive bradykinin production leads to increased vascular permeability and fluid leakage into tissues, causing swelling. By inhibiting plasma kallikrein, berotralstat reduces bradykinin generation, thereby preventing or reducing HAE attacks [1].
What Are the Clinical Trial Results for Berotralstat?
Clinical trials have investigated the efficacy and safety of berotralstat for HAE. Studies have shown a significant reduction in the monthly attack rate for patients treated with berotralstat compared to placebo [1]. Patient-reported outcomes, such as quality of life and well-being, have also been assessed in these trials.
Are There Generic Versions of Berotralstat Available?
Generic versions of berotralstat are typically not available until its primary patents expire and regulatory approval for generics is granted. The availability of biosimilars or generics depends on patent challenges, regulatory pathways, and market dynamics [2].
Who Manufactures Berotralstat?
BioCryst Pharmaceuticals, Inc. is the company developing and marketing berotralstat, known by the brand name Orladeyo [1].
What Are the Risks or Side Effects of Berotralstat?
Common side effects reported in clinical trials include gastrointestinal issues such as diarrhea, nausea, and abdominal pain. More serious adverse events are also monitored, and patients should discuss any concerns with their healthcare provider [1].
How Does Berotralstat Compare to Other HAE Treatments?
Berotralstat offers an oral, once-daily treatment option for HAE. Other HAE treatments include subcutaneous or intravenous self-administered therapies, as well as on-demand medications to treat acute attacks. The choice of treatment often depends on patient preference, frequency of attacks, and physician recommendation [1].
Why is WO2015134998 Important for Berotralstat?
The patent application WO2015134998 is significant as it covers key aspects of berotralstat's use in treating HAE, including specific dosage and administration methods. Such patent protection is crucial for recouping research and development costs and maintaining market exclusivity for the drug [1][2].
Sources:
[1] https://drugpatentwatch.com/
[2] https://drugpatentwatch.com/