cliffwatch

rusfertide acetate · Takeda Pharms Am · NDA 220605

Mimrylo

Earliest generic entry, as listed · earliest of 5 marketed strengths
17 Mar 2034

Blocked by patent: US 10030061, US 10442846, US 10501515, US 11807674, US 12269856, US 9822157.

Listed patents · 6 unexpired

PatentClaimsExpires
US 10030061substance, product17 Mar 2034
US 10442846substance, product, use U-460017 Mar 2034
US 10501515substance, use U-460017 Mar 2034
US 11807674product, use U-460017 Mar 2034
US 12269856use U-460017 Mar 2034
US 9822157substance, product17 Mar 2034

Exclusivities · 1 unexpired

NCEnew chemical entity (5 years)28 Aug 2031

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 · 5

NDA · productFormStrengthListed expiry
220605 · 001 · RLDpowder, subcutaneousEQ 9.5MG BASE/VIAL17 Mar 2034
220605 · 002 · RLDpowder, subcutaneousEQ 19MG BASE/VIAL17 Mar 2034
220605 · 003 · RLDpowder, subcutaneousEQ 28MG BASE/VIAL17 Mar 2034
220605 · 004 · RLDpowder, subcutaneousEQ 41MG BASE/VIAL17 Mar 2034
220605 · 005 · RLDpowder, subcutaneousEQ 54MG BASE/VIAL17 Mar 2034