rocuronium bromide · Fresenius Kabi Usa · NDA 217472, 219108

Rocuronium Bromide

Earliest generic entry, as listed · earliest of 3 marketed strengths
22 Jul 2039

2 of 3 marketed strengths have no unexpired patent or exclusivity listed.

Blocked by patent: US 11998605.

Listed patents · 1 unexpired

PatentClaimsExpires
US 11998605drug product · sets the listed date22 Jul 2039

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
217472 · 001 · RLDsolution, intravenous50MG/5ML (10MG/ML)open
217472 · 002 · RLDsolution, intravenous100MG/10ML (10MG/ML)open
219108 · 001 · RLDsolution, intravenous50MG/5ML (10MG/ML)22 Jul 2039