fish oil triglycerides · Fresenius Kabi Usa · NDA 210589

Omegaven

Earliest generic entry, as listed · earliest of 2 marketed strengths
Open now

No unexpired patents or exclusivities are listed for this product.

Listed patents · 0 unexpired

No unexpired patents listed.

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 · 2

NDA · productFormStrengthListed expiry
210589 · 001 · RLDemulsion, intravenous5GM/50ML (0.1GM/ML)open
210589 · 002 · RLDemulsion, intravenous10GM/100ML (0.1GM/ML)open
Expired or delisted (1)
  • US 9566260 · product, use U-2366 · 30 Jul 2026