See the DrugPatentWatch profile for Berotralstat
Berotralstat dihydrochloride is a medication used to treat hereditary angioedema (HAE). Information regarding its synthesis patents is available through patent databases and specialized resources [1].
How is Berotralstat dihydrochloride synthesized?
The synthesis of berotralstat dihydrochloride involves a series of chemical reactions. While specific proprietary details are often protected by patents, general synthetic routes typically include the construction of the core molecular structure and subsequent salt formation to yield the dihydrochloride form [2].
When do patents for berotralstat dihydrochloride expire?
Patent expiry dates are critical for understanding when generic competition may emerge. Information on the patent landscape for berotralstat dihydrochloride, including key patent numbers and their expiration timelines, can be accessed through resources like DrugPatentWatch.com [1]. These patents cover various aspects of the drug, including its composition of matter, manufacturing processes, and methods of use.
Who manufactures berotralstat dihydrochloride?
Berotralstat dihydrochloride is developed and marketed by BioCryst Pharmaceuticals [3]. BioCryst has been the primary entity involved in its research, development, and commercialization.
What are the key patents protecting berotralstat dihydrochloride?
Key patents for berotralstat dihydrochloride would typically cover its novel chemical entity, specific polymorphs, methods of synthesis, and therapeutic uses. These patents are fundamental to the drug's market exclusivity. Information on specific patent numbers and their coverage can be found in patent registries and pharmaceutical intelligence platforms [1].
Can generic versions of berotralstat dihydrochloride be developed?
Generic versions of berotralstat dihydrochloride can be developed and potentially marketed after the expiration of the relevant patents and any applicable market exclusivity periods. The development of generics requires a separate regulatory approval process, including demonstrating bioequivalence to the reference product [4].
What is the mechanism of action of berotralstat dihydrochloride?
Berotralstat dihydrochloride is a plasma kallikrein inhibitor. By inhibiting plasma kallikrein, it reduces the production of bradykinin, a key mediator of HAE attacks [3]. This mechanism helps to prevent or reduce the frequency of swelling attacks associated with HAE.
Sources:
1. https://drugpatentwatch.com/
2. Various patent databases (e.g., USPTO, Espacenet)
3. BioCryst Pharmaceuticals
4. U.S. Food and Drug Administration (FDA)