🧪 About the Drug

• Generic Name: Rifaximin Tablets, 550 mg
• Reference Brand: Xifaxan®
• Use: Treatment of IBS-D in adults
• US Market Size: $2,672.9 million (as per IQVIA MAT March 2025)

EduDecode: IBS-D is that thing where your stomach disagrees with every buffet you ever loved. And Rifaximin is the peace treaty.

🏭 Where It’ll Be Made

• Zydus’ manufacturing site at SEZ II, Ahmedabad
• This plant is already part of Zydus’ US exports ecosystem

📦 Zydus’ USFDA Track Record

Tentative = Approved from a quality/safety standpoint, but launch delayed due to patent exclusivity or litigation.

🧠 EduInvesting Take

Zydus is showing up to the US pharma party with a very expensive dessert — but the host hasn’t let them in yet.

The $2.67 billion market for Xifaxan is huge. But the tentative approval means:

• There’s still a patent cliff to cross
• No immediate revenue = no EPS pop
• But future upside? Massive — even 5% market share = ~$130M in potential annual revenue

🚨 Risk Factors

• Xifaxan is a heavily patented brand by Bausch Health. Litigation delays are common.
• No launch timeline disclosed
• Price erosion risk once multiple generics get approved (Zydus isn’t alone in filing)

🧮 Revenue Potential: What If?

Assuming price erosion is moderate and patent hurdles clear.

🎯 Focus Keyword: Zydus Rifaximin USFDA Approval

Meta Description: Zydus gets USFDA tentative approval for Rifaximin 550 mg. $2.67B US market opportunity awaits. Will Zydus unlock the next pharma jackpot?

🏷️ Tags:

Zydus Lifesciences, USFDA Approval, Rifaximin Tablets, IBS-D Drug, Indian Pharma Exports, ANDA Approvals, Xifaxan Generic, EduInvesting

Author: Prashant Marathe
Date: June 2, 2025