eltrombopag choline · Teva Pharms Inc · NDA 216774

Alvaiz

Earliest generic entry, as listed · earliest of 4 marketed strengths
5 Nov 2038

Blocked by patent: US 11072586.

Listed patents · 1 unexpired

3 Orange Book listing rows for 1 patent. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.

PatentClaimsExpires
US 11072586drug substance, drug product, use U-3936, U-3937, U-39385 Nov 2038
US 11072586 listing rowdrug substance, drug product, use U-3936 · sets the listed date5 Nov 2038
US 11072586 listing rowdrug substance, drug product, use U-3937 · sets the listed date5 Nov 2038
US 11072586 listing rowdrug substance, drug product, use U-3938 · sets the listed date5 Nov 2038

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 · 4

NDA · productFormStrengthListed expiry
216774 · 001 · RLDtablet, oralEQ 9MG BASE5 Nov 2038
216774 · 002 · RLDtablet, oralEQ 18MG BASE5 Nov 2038
216774 · 003 · RLDtablet, oralEQ 36MG BASE5 Nov 2038
216774 · 004 · RLDtablet, oralEQ 54MG BASE5 Nov 2038