← Patent-cliff monitor small molecule LUTATHERA LUTETIUM LU 177 DOTATATE
Loss of exclusivity January 2039 latest FDA-listed patent expiry
Company ADVANCED ACCELERATOR APPLICATIONS USA INC
Drug detail Brand name LUTATHERA Active ingredient LUTETIUM LU 177 DOTATATE Strength 10mCi/ML Dosage form SOLUTION Route INTRAVENOUS Modality Small molecule FDA approval January 2018 Marketing status RX
Listed patents Patent Expires Type 12168063*PED January 2039 — 12415003*PED January 2039 — 12144873*PED January 2039 — 12151003*PED January 2039 — 12491272*PED January 2039 — 10596278*PED January 2039 — 10596276*PED January 2039 — 12161732*PED January 2039 — 11904027*PED January 2039 — 12168063 July 2038 product 12415003 July 2038 use U-4036 12491272 July 2038 use U-4036 12144873 July 2038 use U-4036 12151003 July 2038 product 12161732 July 2038 product 10596278 July 2038 product 10596276 July 2038 product 11904027 July 2038 product
Regulatory exclusivity Code Expires PED October 2031 ODE-479 April 2031 PED October 2027 NPP April 2027
Source: FDA Orange Book, layered on the CliffBio company graph. Cliff dates are the latest FDA-listed patent expiry; estimates are projections, not legal advice.