plozasiran sodium · Arrowhead · NDA 219947

Redemplo

Earliest generic entry, as listed
10 Sep 2038

Blocked by patent: US 10597657, US 11214801, US 12365899.

Listed patents · 5 unexpired

PatentClaimsExpires
US 10597657substance, product, use U-436010 Sep 2038
US 11214801substance, product, use U-436010 Sep 2038
US 12365899substance, product, use U-436010 Sep 2038
US 10294474substance, product, use U-43607 Mar 2037
US 11174481substance, product7 Mar 2037

Exclusivities · 1 unexpired

ODE-541orphan drug (7 years)18 Nov 2032

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
219947 · 001 · RLDsolution, subcutaneousEQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)10 Sep 2038