cliffwatch

trilaciclib dihydrochloride · Pharmacosmos · NDA 214200

Cosela

Earliest generic entry, as listed
13 Nov 2040

Blocked by patent: US 12168666.

Listed patents · 14 unexpired

17 Orange Book listing rows for 14 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.

PatentClaimsExpires
US 12168666drug substance, drug product · sets the listed date13 Nov 2040
US 11529352use U-350423 Jul 2039
US 12527798use U-35045 Dec 2037
US 8598186drug substance, drug product30 Dec 2034
US 10085992use U-308114 Mar 2034
US 10966984use U-3079, U-308014 Mar 2034
US 10966984 listing rowuse U-307914 Mar 2034
US 10966984 listing rowuse U-308014 Mar 2034
US 11717523use U-3678, U-367914 Mar 2034
US 11717523 listing rowuse U-367814 Mar 2034
US 11717523 listing rowuse U-367914 Mar 2034
US 9487530use U-3079, U-308014 Mar 2034
US 9487530 listing rowuse U-307914 Mar 2034
US 9487530 listing rowuse U-308014 Mar 2034
US 10189849drug substance25 Oct 2031
US 10189850drug product25 Oct 2031
US 10927120drug product25 Oct 2031
US 11040042drug product25 Oct 2031
US 8598197drug substance, drug product25 Oct 2031
US 9957276drug substance25 Oct 2031

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 · 1

NDA · productFormStrengthListed expiry
214200 · 001 · RLDpowder, intravenousEQ 300MG BASE/VIAL13 Nov 2040
Expired or delisted (1)
  • NCE · 12 Feb 2026