Erzofri

(LY03010; paliperidone palmitate)

Small molecule

WWim Janssens

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Clinical

Trials by Indication[1]

Drug1 trial

Relative Bioavailability of LY03010 Compared to Listed Drug

Completed· Luye Pharma Group Ltd. logo

Luye Pharma Group Ltd.·Phase 1·NCT04922593·281 enrolled

Regulatory

FDA Approval Timeline[3]

Jul 31, 2009

INVEGA SUSTENNA

NDA NDA022264

Aug 30, 2021

INVEGA HAFYERA

NDA NDA207946

Jul 26, 2024

ERZOFRI

NDA NDA216352

Sources

References

[1]
ClinicalTrials.gov — 1 trial record for LY03010; paliperidone palmitate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — LY03010; paliperidone palmitate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA216352). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Erzofri. U.S. Food & Drug Administration.
[5]
SEC EDGAR — Wim Janssens company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: WWim Janssens

Patent Landscape[4]

Patent Cliff

Jan 26, 2031

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9439906Jan 26, 2031

10143693Apr 5, 2036

12128049Oct 26, 2038

11666573Sep 24, 2039

11324751May 7, 2041

3 more patents

11304951May 7, 2041

12208100May 7, 2041

11666697Nov 24, 2041