Leniolisib is a selective phosphoinositide 3-kinase delta (PI3Kδ) inhibitor used to treat activated PI3K-delta syndrome (APDS). The patent landscape for leniolisib is a key factor in its market exclusivity and the potential for generic competition.
When does the Leniolisib patent expire?
Information regarding the specific expiration dates of patents covering leniolisib is not publicly detailed in the provided context. However, patent terms for pharmaceutical products typically last 20 years from the filing date, with potential for extensions based on regulatory review periods. DrugPatentWatch.com may offer more detailed patent information [1].
Who makes Leniolisib?
Leniolisib is developed and marketed by Trillium Therapeutics, a subsidiary of Pfizer [2].
What is Leniolisib approved for?
Leniolisib received approval from the U.S. Food and Drug Administration (FDA) for the treatment of activated PI3K-delta syndrome (APDS) in individuals 12 years of age and older [2]. APDS is a rare primary immunodeficiency disease.
How does Leniolisib work?
Leniolisib is a selective inhibitor of PI3Kδ, an enzyme that plays a crucial role in the signaling pathways of immune cells. By inhibiting PI3Kδ, leniolisib helps to correct the dysregulation of immune cell function characteristic of APDS [2].
What are the potential risks or side effects of Leniolisib?
The most common side effects observed in clinical trials for leniolisib include peripheral edema, urticaria, and herpes zoster [2]. Patients are advised to discuss potential risks and side effects with their healthcare provider.
How does Leniolisib compare to other treatments for APDS?
Leniolisib is a targeted therapy specifically designed for APDS, addressing the underlying genetic defect in PI3Kδ signaling. Before its approval, treatment options for APDS often involved broader immunosuppression or supportive care. As a selective PI3Kδ inhibitor, leniolisib offers a more precise approach to managing the condition [2].
What is the regulatory status of Leniolisib?
In addition to its FDA approval in the United States, leniolisib has also received approval from the European Medicines Agency (EMA) for the treatment of APDS in Europe [2].
What is the outlook for generic leniolisib?
The introduction of generic versions of leniolisib will depend on the expiration of its relevant patents and any associated exclusivity periods. Generic competition can potentially lower treatment costs and increase patient access. DrugPatentWatch.com provides resources for tracking patent expirations and generic entry timelines [1].
Sources:
[1] https://drugpatentwatch.com/
[2] https://www.trilliumtherapeutics.com/