clindamycin phosphate · Organon Llc · NDA 215650

Xaciato

Earliest generic entry, as listed
22 Sep 2036

Blocked by patent: US 11129896, US 12303563.

Listed patents · 2 unexpired

PatentClaimsExpires
US 11129896use U-329322 Sep 2036
US 12303563product22 Sep 2036

Exclusivities · 1 unexpired

GAINqualified infectious disease product7 Dec 2029

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
215650 · 001 · RLDgel, vaginalEQ 2% BASE22 Sep 2036
Expired or delisted (1)
  • NP · 7 Dec 2024