ephedrine sulfate · Nexus · NDA 213407

Emerphed

Earliest generic entry, as listed · earliest of 2 marketed strengths
16 May 2040

Blocked by patent: US 11090278, US 11241400, US 11464752, US 11478436, US 11571398.

Listed patents · 5 unexpired

PatentClaimsExpires
US 11090278use U-3183 · sets the listed date16 May 2040
US 11241400use U-3183 · sets the listed date16 May 2040
US 11464752drug product · sets the listed date16 May 2040
US 11478436use U-3183 · sets the listed date16 May 2040
US 11571398use U-3183 · sets the listed date16 May 2040

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
213407 · 001 · RLDsolution, intravenous50MG/10ML (5MG/ML)16 May 2040
213407 · 002 · RLDsolution, intravenous25MG/5ML (5MG/ML)16 May 2040