Cysteine Hydrochloride

(rifaximin + N-acetylcysteine three times)

Small molecule

BBaxter Healthcare Corporation

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Timeline

Expected Milestones

Q1 2027

Phase 2Not yet recruiting

Rifaximin

NCT06727422

Clinical

Trials by Indication[1]

Rifaximin1 trial

Efficacy of Rifaximin With NAC in IBS-D

Not yet recruiting·MMark Pimentel, MD·Phase 2·NCT06727422·225 enrolled

Regulatory

FDA Approval Timeline[3]

Oct 22, 1986

CYSTEINE HYDROCHLORIDE

NDA NDA019523

Apr 16, 2019

ELCYS

NDA NDA210660

Dec 13, 2019

NOURESS

NDA NDA212535

Sources

References

[1]
ClinicalTrials.gov — 1 trial record for rifaximin + N-acetylcysteine three times. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — rifaximin + N-acetylcysteine three times compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA212535). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Cysteine Hydrochloride. U.S. Food & Drug Administration.
[5]
SEC EDGAR — Baxter Healthcare Corporation company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: BBaxter Healthcare Corporation

Patent Landscape[4]

Patent Cliff

Jan 14, 2039

Earliest patent expiration — generic entry possible after this date

Patent #Expires

12569514Jan 14, 2039