ferric pyrophosphate citrate · Rockwell Medical Inc · NDA 206317, 208551

Triferic

Earliest generic entry, as listed · earliest of 3 marketed strengths
17 Apr 2029

1 of 3 marketed strengths has no unexpired patent or exclusivity listed; no marketed reference-listed strength; date taken from all listed strengths.

Blocked by patent: US 7816404. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.

Listed patents · 2 unexpired

PatentClaimsExpires
US 7816404product, use U-165617 Apr 2029
US 7857977use U-16568 Sep 2027

Exclusivities · 0 unexpired

No unexpired exclusivities listed.

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 · 3

NDA · productFormStrengthListed expiry
206317 · 001 · RLD · discontinuedsolution, intravenous27.2MG IRON/5ML (5.44MG IRON/ML)17 Apr 2029
206317 · 002 · RLD · discontinuedsolution, intravenous272MG IRON/50ML (5.44MG IRON/ML)open
208551 · 001 · RLD · discontinuedpowder, intravenous272MG IRON/PACKET17 Apr 2029