cliffwatch

lutetium lu-177 dotatate · Aaa Usa Inc · NDA 208700

Lutathera

Earliest generic entry, as listed
25 Jan 2039

Blocked by patent: US 10596276, US 10596278, US 11904027, US 12144873, US 12151003, US 12161732, US 12168063, US 12415003, US 12491272.

Listed patents · 18 unexpired

PatentClaimsExpires
US 10596276—25 Jan 2039
US 10596278—25 Jan 2039
US 11904027—25 Jan 2039
US 12144873—25 Jan 2039
US 12151003—25 Jan 2039
US 12161732—25 Jan 2039
US 12168063—25 Jan 2039
US 12415003—25 Jan 2039
US 12491272—25 Jan 2039
US 10596276product25 Jul 2038
US 10596278product25 Jul 2038
US 11904027product25 Jul 2038
US 12144873use U-403625 Jul 2038
US 12151003product, use U-403625 Jul 2038
US 12161732product, use U-403625 Jul 2038
US 12168063product, use U-403625 Jul 2038
US 12415003use U-403625 Jul 2038
US 12491272use U-403625 Jul 2038

Exclusivities · 4 unexpired

PEDpediatric (6 months added)23 Oct 2031
ODE-479orphan drug (7 years)23 Apr 2031
PEDpediatric (6 months added)23 Oct 2027
NPPnew patient population23 Apr 2027

Paragraph IV certifications · 0

No Paragraph IV certification listed by FDA for this drug.

The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.

Event history

  • 25 Oct 2026First generic approved · 208700-001
  • 25 Oct 2026Generic approved · 208700-001

Products covered · 1

NDA · productFormStrengthListed expiry
208700 · 001 · RLDsolution, intravenous10mCi/ML25 Jan 2039