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Rifaximin plus lactulose
Rifaximin plus lactulose is a marketed combination therapy developed by the Institute of Liver and Biliary Sciences in India, primarily indicated for liver-related conditions. The key composition patent expires in 2028, providing a strong barrier to generic competition until then. The primary risk is the lack of detailed revenue data and key trial results, which may limit investor confidence and market valuation.
At a glance
| Generic name | Rifaximin plus lactulose |
|---|---|
| Also known as | Rifaxa plus Duphalac |
| Sponsor | Institute of Liver and Biliary Sciences, India |
| Modality | Small molecule |
| Phase | FDA-approved |
Approved indications
Common side effects
Key clinical trials
- Evaluation of the Outcome of Fecal Microbiota Transplantation (PHASE1, PHASE2)
- Efficacy and Safety of Early Initiation of Midodrine for Control and Prevention of Ascites and Its Related Complications in Acute-on-chronic Liver Failure. (NA)
- Hydrogen Breath Test an Instrument to Predict Rifaximin-Response in Irritable Bowel Syndrome Predominant Diarrhea (PHASE4)
- Efficacy and Safety of Nifuroxazide in the Treatment of Hepatic Encephalopathy in Egyptian Patients With Liver Cirrhosis (PHASE3)
- A Trial for Comparing Rifaximin, Probiotic and L-ornithine- L Aspartate With Lactulose in Overt Hepatic Encephalopathy. (PHASE4)
- BCAA vs. Rifaximin in Patients With Cirrhosis for Secondary Prophylaxis of HE (PHASE4)
- Longitudinal Monitoring of Stool Characteristics
- Goal Directed Ammonia Lowering Therapy in Hyperammonemic ACLF Patients With no Overt HE to Reduce Major Adverse Liver Related Outcomes (GOAL Trial) (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Rifaximin plus lactulose CI brief — competitive landscape report
- Rifaximin plus lactulose updates RSS · CI watch RSS
- Institute of Liver and Biliary Sciences, India portfolio CI