Zydus Bags Tentative USFDA Nod for $2.67 Billion Rifaximin — Blockbuster or Waiting Room?

🧪 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 atSEZ
  • II, Ahmedabad
  • This plant is already part of Zydus’ US exports ecosystem

📦 Zydus’ USFDA Track Record

MetricCount
ANDA Filings (since FY04)492
ANDA Approvals427
Current Filing StatusTentative Approval

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

🧠 EduInvesting Take

Zydus is showing up to the

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