What is Berotralstat Hydrochloride Crystalline Form?
Berotralstat hydrochloride is a drug that functions as a plasma kallikrein inhibitor. It is used to prevent attacks of hereditary angioedema (HAE) [1]. The crystalline form of berotralstat hydrochloride refers to a specific solid-state structure of the drug compound. Different crystalline forms can impact a drug's properties, such as its stability, solubility, and bioavailability [2].
When did the Berotralstat Hydrochloride Crystalline Form Patent Emerge?
Information regarding the specific patent filing or grant date for the berotralstat hydrochloride crystalline form is not readily available in the provided context. Patent details, including filing and expiration dates, are typically found in patent databases.
How Long Will the Patent for Berotralstat Hydrochloride Crystalline Form Last?
The duration of a patent for a crystalline form is generally linked to the patent protection of the active pharmaceutical ingredient itself, as well as any specific patents granted for the crystalline form. These patents typically last for 20 years from the filing date. However, patent term extensions may be available in some jurisdictions to compensate for regulatory delays [3]. For specific expiration dates, a review of patent filings would be necessary. DrugPatentWatch.com can be a resource for such information [4].
What Companies are Involved with Berotralstat Hydrochloride?
BioCryst Pharmaceuticals is the company that developed and markets berotralstat hydrochloride, under the brand name Orladeyo [1].
What are the Therapeutic Uses of Berotralstat Hydrochloride?
Berotralstat hydrochloride is indicated for the prophylactic treatment of hereditary angioedema (HAE) attacks in adult and pediatric patients 12 years and older [1].
What are the Potential Side Effects of Berotralstat Hydrochloride?
Common side effects associated with berotralstat hydrochloride include upper respiratory tract infection, nasopharyngitis, and headache [1].
Are There Any Known Interactions with Berotralstat Hydrochloride?
Berotralstat hydrochloride can interact with certain medications, including strong CYP3A4 inhibitors and inducers, as well as P-glycoprotein inhibitors and inducers. Caution is advised when co-administering with these agents [1].
Can Biosimilars be Developed for Berotralstat Hydrochloride Crystalline Form?
The development of biosimilars for biologic drugs is a distinct process. Berotralstat hydrochloride is a small molecule drug, not a biologic. Therefore, the concept of biosimilars does not directly apply. Instead, generic versions of small molecule drugs can be developed and may be approved once patents expire and other regulatory exclusivities have lapsed [5]. The crystalline form itself could be a target for patent protection, potentially influencing when generic versions of the drug become available.
Where Can I Find More Information on Berotralstat Hydrochloride Crystalline Form Patents?
Detailed information on patents, including those related to crystalline forms, can be found in patent databases and specialized intellectual property resources. Websites like DrugPatentWatch.com offer tools and data to track drug patents and their expiration timelines [4].
Sources:
1. https://www.orladeyo.com/
2. https://www.drugpatentwatch.com/drug/berotralstat-hydrochloride
3. https://www.drugpatentwatch.com/news/understanding-drug-patent-terms-and-extensions
4. https://www.drugpatentwatch.com/
5. https://www.fda.gov/drugs/abbreviated-new-drug-applications-andas/understanding-generics