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Neoprofen

(Comparator - Dolormin ibuprofen lysine tablets)

Small molecule

RRECORDATI GROUP

0

Indications

2

Total Trials

0

Active Trials

0

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

1

Patents

Clinical

Trials by Indication[1]

Ibuprofen2 trials

Ibuprofen Bioavailability Study

Completed·RReckitt Benckiser Healthcare (UK) Limited·Phase 1·NCT03180879·36 enrolled

Ibuprofen and Pseudoephedrine Comparative Pharmacokinetic Study

Completed·RReckitt Benckiser Healthcare (UK) Limited·Phase 1·NCT03184766·55 enrolled

Regulatory

FDA Approval Timeline[3]

Apr 13, 2006

NEOPROFEN

NDA NDA021903

Sources

References

[1]
ClinicalTrials.gov — 2 trial records for Comparator - Dolormin ibuprofen lysine tablets. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Comparator - Dolormin ibuprofen lysine tablets compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA021903). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Neoprofen. U.S. Food & Drug Administration.
[5]
SEC EDGAR — RECORDATI GROUP company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: RRECORDATI GROUP

Patent Landscape[4]

Patent Cliff

Mar 2, 2032

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8415337Mar 2, 2032

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