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Patent application WO2015134998A1 relates to human plasma kallikrein inhibitors, including those that can be used to treat hereditary angioedema (HAE). Berotralstat, an oral kallikrein inhibitor, is among the compounds described in this patent family [1].
What does this patent protect regarding berotralstat?
The patent application WO2015134998A1 and related documents describe and claim specific chemical compounds that inhibit human plasma kallikrein, as well as methods of using these compounds to treat conditions like HAE [1]. Berotralstat is identified as a compound within this class of inhibitors [1].
When does the patent for berotralstat expire?
The patent landscape for berotralstat is complex and involves multiple patents and applications, making a single expiry date difficult to pinpoint without detailed analysis. However, the original patent application WO2015134998A1 is a publication and not a granted patent itself. Berotralstat's market exclusivity is influenced by granted patents stemming from this and other applications, as well as potential patent term extensions and data exclusivity periods [2, 3]. Information on specific patent expiry dates can be found on specialized patent databases like DrugPatentWatch.com [2].
How does berotralstat work to treat hereditary angioedema?
Berotralstat functions by inhibiting plasma kallikrein, an enzyme that plays a key role in the overproduction of bradykinin. In HAE, excessive bradykinin leads to the swelling characteristic of the disease. By blocking kallikrein, berotralstat reduces bradykinin levels, thereby preventing or reducing HAE attacks [1].
Are there other drugs like berotralstat for HAE?
Yes, other treatments for HAE exist. These include injectable medications that target different aspects of the kallikrein-kinin system, such as C1 esterase inhibitors and kallikrein inhibitors [4]. Berotralstat is notable for being an oral therapy [1].
What are the clinical trial results for berotralstat?
Clinical trials have evaluated berotralstat's efficacy and safety in patients with HAE. Studies have demonstrated a reduction in the monthly attack rate of HAE in patients treated with berotralstat compared to placebo [5].
What are the potential side effects of berotralstat?
Commonly reported side effects in clinical trials for berotralstat include gastrointestinal issues such as diarrhea and abdominal pain, as well as headache [5].
What is the regulatory status of berotralstat?
Berotralstat has received regulatory approval in various regions. For example, it is approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the prophylactic treatment of HAE [6, 7].
Who manufactures berotralstat?
BioCryst Pharmaceuticals is the developer and manufacturer of berotralstat [6].
What is the cost of berotralstat?
The cost of berotralstat can be significant, reflecting the specialized nature of rare disease treatments. Pricing details are typically available through pharmacies or patient assistance programs [8].
What are the patent challenges or litigation surrounding berotralstat?
The pharmaceutical industry often sees patent litigation, especially for novel drugs like berotralstat. Companies may challenge patents to pave the way for generic competition or to protect their own market position. Detailed information on any specific patent challenges or litigation concerning berotralstat would require access to legal and patent databases [2].
Can biosimilars be developed for berotralstat?
Berotralstat is a small molecule drug, not a biologic. Therefore, the concept of biosimilars, which applies to biologic medications, is not directly applicable. However, generic versions of small molecule drugs can be developed after patent expiry [2].
Sources:
[1] https://patents.google.com/patent/WO2015134998A1/en
[2] https://drugpatentwatch.com/
[3] https://www.drugpatentwatch.com/berotralstat-oral-h-ae-treatment/drug-patents
[4] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8351218/
[5] https://www.nejm.org/doi/full/10.1056/NEJMoa2005051
[6] https://www.fda.gov/drugs/drug-approvals-and-databases/drug-approvals-archive
[7] https://www.ema.europa.eu/en/medicines/human/EPAR/orladeyo
[8] https://www.biocryst.com/pipeline/commercial-products/oral-h-ae-therapy/