See the DrugPatentWatch profile for berotralstat
How is Berotralstat Synthesized?
The synthesis of berotralstat involves a multi-step process. Key steps include reacting a benzoyl chloride derivative with an amine to form an amide, followed by further functionalization and cyclization to construct the final molecule. The process requires careful control of reaction conditions to ensure purity and yield [1].
What are the Key Patents for Berotralstat?
Several patents cover the synthesis and use of berotralstat. For example, U.S. Patent No. 10,913,733 B2, assigned to BioCryst Pharmaceuticals, Inc., describes methods of preparing berotralstat [1]. Information on berotralstat's patent landscape can be found on DrugPatentWatch.com [2].
When Does Berotralstat's Patent Protection Expire?
The expiration of patent protection for berotralstat will determine when generic versions can enter the market. U.S. Patent No. 10,913,733 B2 is expected to expire in 2037. However, additional patents related to formulation or method of use may extend market exclusivity further [1, 2].
Who Manufactures Berotralstat?
Berotralstat is developed and manufactured by BioCryst Pharmaceuticals, Inc. [1].
What is Berotralstat Used For?
Berotralstat, marketed as Orladeyo, is a plasma kallikrein inhibitor used for the prophylactic treatment of hereditary angioedema (HAE) in adult and pediatric patients 12 years and older [3].
How Effective is Berotralstat in Clinical Trials?
Clinical trials have demonstrated berotralstat's efficacy in reducing the number of HAE attacks. In the APeX-2 study, patients taking berotralstat experienced a significant reduction in monthly HAE attack rates compared to placebo [3].
What are the Potential Side Effects of Berotralstat?
Common side effects reported in clinical trials include gastrointestinal issues such as diarrhea, nausea, and abdominal pain. Patients should discuss any concerns about side effects with their healthcare provider [3].
What is the Difference Between Berotralstat and Other HAE Treatments?
Berotralstat is an oral, once-daily therapy, distinguishing it from injectable HAE treatments. It targets plasma kallikrein, an enzyme involved in the HAE attack cascade [3].
What is the Future Outlook for Berotralstat?
The drug's oral administration and established efficacy position it as a significant treatment option for HAE patients. Ongoing research and potential label expansions could further influence its market presence [3].
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Sources:
1. U.S. Patent No. 10,913,733 B2. (n.d.).
2. DrugPatentWatch.com. (n.d.). Berotralstat.
3. BioCryst Pharmaceuticals, Inc. (n.d.). Orladeyo® (berotralstat) Prescribing Information.