octreotide acetate · Chiesi · NDA 208232

Mycapssa

Earliest generic entry, as listed
28 Dec 2040

Blocked by patent: US 11141457, US 11890316. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.

Listed patents · 16 unexpired

PatentClaimsExpires
US 11141457use U-3232 · sets the listed date28 Dec 2040
US 11890316use U-3232 · sets the listed date28 Dec 2040
US 10238709use U-28573 Feb 2036
US 10695397use U-28573 Feb 2036
US 11052126use U-28573 Feb 2036
US 11338011use U-28573 Feb 2036
US 11510963use U-28573 Feb 2036
US 11857595use U-37843 Feb 2036
US 12246054use U-28573 Feb 2036
US 12251418use U-28573 Feb 2036
US 11969471drug product17 Sep 2029
US 11986529use U-285717 Sep 2029
US 8329198drug product17 Sep 2029
US 8535695use U-285717 Sep 2029
US 9265812drug product17 Sep 2029
US 9566246drug product17 Sep 2029

Exclusivities · 1 unexpired

ODE-474orphan drug (7 years)26 Jun 2027

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 · 1

NDA · productFormStrengthListed expiry
208232 · 001 · RLDcapsule, delayed release, oralEQ 20MG BASE28 Dec 2040