small molecule

LUTATHERA

LUTETIUM LU-177 DOTATATE

Loss of exclusivityJanuary 2039latest FDA-listed patent expiry

CompanyADVANCED 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.