copper cu-64 dotatate · Curium · NDA 213227

Detectnet

Earliest generic entry, as listed
3 Sep 2041

Blocked by patent: US 12102696.

Listed patents · 4 unexpired

PatentClaimsExpires
US 12102696product3 Sep 2041
US 10383961use U-29512 Jul 2033
US 10159759use U-295123 Aug 2032
US 11160888use U-295123 Aug 2032

Exclusivities · 1 unexpired

ODE-317orphan drug (7 years)3 Sep 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

No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.

Products covered · 1

NDA · productFormStrengthListed expiry
213227 · 001 · RLDsolution, intravenous4mL (1mCi/ML)3 Sep 2041