BioTech IP Review

Assignee: Mirati Therapeutics, Inc.
Patent Number: 12,383,503 B2
Filed: August 5, 2024
Issued: August 12, 2025
Inventors: Cletus Nunes, Mehrdad Kheiripour, Monika Gavireddi

What the Patent Covers

This patent protects solid pharmaceutical compositions of adagrasib — the orally administered KRAS G12C inhibitor developed by Mirati for treating certain cancers (notably non‑small‑cell lung cancer and other KRAS G12C‑mutant tumors).
Specifically, the patent claims:

• Pharmaceutical solid forms (e.g., tablets, capsules) that include adagrasib as the active ingredient.
• Methods of manufacturing these solid dosage forms with desirable properties (e.g., stability, bioavailability).
• Methods of treating cancer by administering these compositions to subjects with cancerous tumors responsive to KRAS G12C inhibition.

Why This Patent Is Significant

• Core Product Protection: Adagrasib (brand name Krazati) is one of Mirati’s leading commercial products and a cornerstone of its oncology portfolio. The solid composition patent strengthens IP around how the drug is delivered as a patient‑friendly oral treatment, which directly impacts market exclusivity.
• Commercial Value: By safeguarding formulations suitable for routine clinical use, Mirati can better defend against generic competition and protect revenue streams tied to adagrasib sales.
• Manufacturing and Treatment Claims: Including methods of manufacture and treatment in the patent broadens its protective scope — not just covering composition‑of‑matter but also the practical therapeutic use.