What is Orladeyo berotralstat?
Orladeyo (berotralstat) is an oral therapy used for the prophylactic treatment of hereditary angioedema (HAE) in adult and pediatric patients 12 years and older [1]. It functions by inhibiting plasma kallikrein [1].
What are the crystalline salt forms of berotralstat?
Berotralstat hydrochloride, specifically a crystalline salt form, is utilized in Orladeyo [2]. This crystalline structure contributes to the drug's stability and formulation [2].
When does the berotralstat patent expire?
The patent landscape for berotralstat is complex, with multiple patents covering different aspects of the drug and its formulations. For instance, U.S. Patent No. 11,597,734, which covers a crystalline salt form of berotralstat, is expected to expire around 2041 [3]. DrugPatentWatch.com provides detailed information on patent expiry dates and exclusivities for berotralstat [4].
How does berotralstat's patent differ from other HAE treatments?
Patents for HAE treatments often focus on the active pharmaceutical ingredient, specific salt forms, manufacturing processes, or methods of use. The crystalline salt patent for berotralstat is an example of protection for a specific physical form of the drug, which can impact its bioavailability and manufacturing [2, 3]. This differs from patents covering, for example, antibody-based therapies for HAE which target different biological pathways [5].
What is the status of berotralstat litigation or challenges?
Information regarding specific litigation or patent challenges concerning berotralstat's crystalline salt patent is not detailed in the provided context. However, patent challenges are common in the pharmaceutical industry, particularly as exclusivity periods approach, aiming to enable generic competition [4].
What are the clinical data and patient concerns for Orladeyo?
Orladeyo has demonstrated a significant reduction in HAE attack rates in clinical trials [1]. Common side effects reported include gastrointestinal issues such as diarrhea, abdominal pain, and nausea [1]. Patients and healthcare providers consider factors like oral administration and efficacy in managing HAE symptoms [1, 5].
Who are the competitors in the HAE treatment market?
The HAE treatment market includes other prophylactic therapies such as Lanadelumab (Takhzyro), which is an injectable biologic, and C1 esterase inhibitor (C1-INH) concentrates [5]. Berotralstat's oral administration offers a distinct alternative to injectable treatments [1].
Sources:
[1] https://www.orladeyo.com/
[2] https://pubchem.ncbi.nlm.nih.gov/compound/Berotralstat
[3] https://patents.google.com/patent/US11597734B2/en
[4] https://drugpatentwatch.com/
[5] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7351428/