rosuvastatin calcium · Sun Pharm · NDA 208647

Ezallor Sprinkle

Earliest generic entry, as listed · earliest of 4 marketed strengths
12 Feb 2036

No marketed reference-listed strength; date taken from all listed strengths.

Blocked by patent: US 10413543.

Listed patents · 1 unexpired

PatentClaimsExpires
US 10413543product12 Feb 2036

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
208647 · 001 · RLD · discontinuedcapsule, oralEQ 5MG BASE12 Feb 2036
208647 · 002 · RLD · discontinuedcapsule, oralEQ 10MG BASE12 Feb 2036
208647 · 003 · RLD · discontinuedcapsule, oralEQ 20MG BASE12 Feb 2036
208647 · 004 · RLD · discontinuedcapsule, oralEQ 40MG BASE12 Feb 2036