Ribociclib Tablet
Patent No. EP4197530 (titled "Ribociclib Tablet") was filed by Novartis on Apr 14, 2016. The application was issued on Nov 12, 2025.
Patent Summary
This invention provides a coated pharmaceutical oral tablet comprising ribociclib succinate (also known as LEE011), a cyclin-dependent kinase (CDK1, CDK2, CDK3, CDK4, CDK5, CDK6, CDK9) inhibitor and glycogen synthase kinase-3 (GSK-3) modulator. The tablet core contains at least 40% w/w ribociclib succinate and may include fillers (cellulose, mannitol, di-calcium phosphate, lactose, microcrystalline cellulose), binders (hydroxypropyl cellulose, polyvinyl-pyrrolidone), and lubricants (magnesium stearate, stearic acid, talc, silicon dioxide, sodium stearyl fumarate). The tablet is finished with an aqueous moisture barrier coating comprising polyvinyl alcohol (PVA), such as Opadry® amb II. This PVA-based coating prevents tablet cracking and logo bridging defects observed with standard HPMC-based coatings (e.g., Opadry®), ensuring high stability, high drug load, and an immediate release profile.
Patent Family
Patent Oppositions (3)
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Dossier Documents
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Date
Description
EP4197530
- Application Number
- EP22203730A
- Filing Date
- Apr 14, 2016
- Status
- Granted And Under Opposition
- Oct 10, 2025
- Publication Date
- Nov 12, 2025
- External Links
- Slate, Register , Google Patents