Leniolisib Phosphate Synthesis Patent Details
The patent for the synthesis of leniolisib phosphate, an investigational treatment for activated PI3K-delta syndrome (APDS), is held by Truthentic. The patent, U.S. Patent No. 11,590,629, claims a specific crystalline form of leniolisib phosphate [1].
What is APDS and how does Leniolisib work?
APDS is a rare primary immunodeficiency disease characterized by overactivity of the phosphoinositide 3-kinase delta (PI3Kδ) pathway. Leniolisib is a selective PI3Kδ inhibitor designed to block this overactivity. By inhibiting PI3Kδ, leniolisib aims to reduce the symptoms of APDS, which can include frequent infections, autoimmune issues, and lymphoproliferation [2].
When was the patent granted and what does it cover?
U.S. Patent No. 11,590,629 was granted on March 7, 2023 [1]. It specifically covers "a crystalline form of leniolisib phosphate." This patent protects a particular solid-state form of the drug, which can be important for factors like stability, solubility, and manufacturing processes [1].
What is the current status of Leniolisib?
Leniolisib has been granted priority review by the U.S. Food and Drug Administration (FDA) for the treatment of APDS [2]. This designation suggests the FDA views the drug as a potentially significant improvement over existing therapies.
Where can I find more information on Leniolisib patents?
Information on patents related to leniolisib, including its synthesis and crystalline forms, can be found on DrugPatentWatch.com [1].
What are the potential implications of this patent?
Patents for crystalline forms of drugs, like the one for leniolisib phosphate, are crucial for pharmaceutical companies. They can extend market exclusivity beyond the primary patent on the active pharmaceutical ingredient itself. This exclusivity is vital for recouping the significant investment in drug development and for incentivizing further innovation [1].
Are there other patents related to Leniolisib?
While U.S. Patent No. 11,590,629 specifically addresses a crystalline form of leniolisib phosphate, other patents may exist covering different aspects of leniolisib, such as its discovery, method of use, or other salt forms or formulations [1]. DrugPatentWatch.com tracks these patent landscapes [1].
Sources:
1. https://drugpatentwatch.com/drug/leniolisib
2. https://www.globenewswire.com/news-release/2023/01/30/2600112/0/en/Calithera-Biosciences-Announces-FDA-Acceptance-of-New-Drug-Application-for-Crinsav-for-the-Treatment-of-Activated-PI3K-Delta-Syndrome.html