flotufolastat f-18 gallium · Blue Earth · NDA 216023

Posluma

Earliest generic entry, as listed
27 Nov 2041

Blocked by patent: US 12036290, US 12036290, US 12427207.

Listed patents · 8 unexpired

PatentClaimsExpires
US 12036290product, use U-361527 Nov 2041
US 12036290product, use U-361427 Nov 2041
US 12427207product27 Nov 2041
US 11413360substance, use U-361422 Nov 2038
US 11413360substance, use U-361522 Nov 2038
US 12357711substance22 Nov 2038
US 12377176substance22 Nov 2038
US 12390540substance23 Aug 2038

Exclusivities · 1 unexpired

NCEnew chemical entity (5 years)25 May 2028

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
216023 · 001 · RLDsolution, intravenous25ML (8-158mCi/ML)27 Nov 2041