mobocertinib succinate · Takeda Pharms Usa · NDA 215310

Exkivity

Earliest generic entry, as listed
13 May 2035

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

Blocked by patent: US 10227342, US 9796712.

Listed patents · 2 unexpired

PatentClaimsExpires
US 10227342drug substance, drug product, use U-3220 · sets the listed date13 May 2035
US 9796712drug substance, drug product · sets the listed date13 May 2035

Exclusivities · 1 unexpired

ODE-374orphan drug (7 years)15 Sep 2028

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
215310 · 001 · RLD · discontinuedcapsule, oralEQ 40MG BASE13 May 2035
Expired or delisted (1)
  • NCE · 15 Sep 2026