risperidone · Indivior · NDA 210655

Perseris Kit

Earliest generic entry, as listed · earliest of 2 marketed strengths
13 Feb 2028

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

Blocked by patent: US 10010612, US 10376590, US 11013809, US 11712475, US 9180197, US 9186413.

Listed patents · 7 unexpired

PatentClaimsExpires
US 10010612product13 Feb 2028
US 10376590use U-260813 Feb 2028
US 11013809product, use U-313513 Feb 2028
US 11712475use U-313513 Feb 2028
US 9180197product13 Feb 2028
US 9186413use U-54313 Feb 2028
US 11110093product, use U-31355 Nov 2026

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
210655 · 001 · RLD · discontinuedfor suspension, extended release, subcutaneous90MG13 Feb 2028
210655 · 002 · RLD · discontinuedfor suspension, extended release, subcutaneous120MG13 Feb 2028
Expired or delisted (3)
  • US 10058554 · use U-2363 · 26 Sep 2026
  • US 9597402 · product · 26 Sep 2026
  • US 10406160 · product, use U-2608 · 26 Jun 2026