How is Berotralstat Synthesized?
The synthesis of berotralstat involves a multi-step chemical process [1]. While specific details of the crystalline salt formation are proprietary, the general approach to developing such salts focuses on optimizing properties like solubility, stability, and bioavailability [2]. The choice of salt form can significantly impact a drug's performance [2].
What Patents Cover Berotralstat?
Berotralstat is protected by several patents. These patents cover the compound itself, as well as various crystalline forms and methods of use [1][3]. For instance, patents may describe specific crystalline salts of berotralstat, such as the hydrobromide salt [4]. Information on patent expiry dates for berotralstat and its associated intellectual property can be found on resources like DrugPatentWatch.com [3].
When Does Berotralstat's Patent Exclusivity End?
Patent exclusivity for berotralstat varies depending on the specific patent covering the compound, its formulations, or methods of treatment [3]. Determining the precise end date of market exclusivity requires examining the expiration of all relevant patents. DrugPatentWatch.com provides tools and data to track these patent lifecycles [3].
Who Manufactures Berotralstat?
BioCryst Pharmaceuticals developed and manufactures berotralstat [1]. The commercialization of berotralstat is a key focus for BioCryst [1].
What Are the Crystalline Forms of Berotralstat?
Berotralstat can exist in different crystalline forms, and specific salt forms, such as the hydrobromide salt, have been detailed in patent literature [4]. The development of specific crystalline forms is often a strategic part of pharmaceutical patenting, aiming to secure protection for distinct physical properties of the drug substance [2][4].
What are the Risks or Challenges in Berotralstat Synthesis?
The synthesis of complex organic molecules like berotralstat can present challenges related to yield, purity, and scalability [1]. The development of specific crystalline salt forms also requires careful control of crystallization conditions to ensure consistency and desired physical properties [2].
How Does Berotralstat Compare to Other Hereditary Angioedema Treatments?
Berotralstat is a self-administered oral therapy for the prophylactic treatment of hereditary angioedema (HAE) [1]. Unlike some other HAE treatments that require injection or infusion, berotralstat offers an oral administration option [1]. This difference in administration route can be a significant factor for patients managing a chronic condition [1].
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Sources:
[1] BioCryst Pharmaceuticals. (n.d.). Berotralstat. Retrieved from https://www.biocryst.com/our-products/berotralstat/
[2] Pharmaceutical Drug Development. (n.d.). Salt Forms. Retrieved from https://www.drugdevelopment.com/drug-formulation/salt-forms
[3] DrugPatentWatch.com. (n.d.). Berotralstat Patents. Retrieved from https://www.drugpatentwatch.com/search?q=berotralstat
[4] US Patent 9,775,752 B2. (2017). PYRIMIDINE DERIVATIVES AS ORAL KALLIKREIN INHIBITORS. Retrieved from https://patents.google.com/patent/US9775752B2