Lupin receives tentative FDA approval for novel apixaban oral suspension
- Lupin received tentative FDA approval for Apixaban Oral Suspension 1.25mg/mL on September 28, 2026
- The product was approved via the 505(b)(2) regulatory pathway as a liquid alternative to tablets
- Manufacturing will occur at Lupin's facility in Somerset, New Jersey upon final approval
*this image is generated using AI for illustrative purposes only.
Lupin Limited announced on September 28, 2026, that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its New Drug Application for Apixaban Oral Suspension 1.25mg/mL.
The product was approved via the 505(b)(2) regulatory pathway. This oral liquid formulation of apixaban serves as an alternative administration option for adult patients requiring anticoagulation therapy, specifically targeting those who may have difficulty swallowing tablets.
Product differentiation and market positioning
Apixaban is the active ingredient in Eliquis®, a drug marketed by Bristol Myers Squibb. Lupin's new formulation expands the ways in which this important therapy can be administered. The company stated that this development reinforces its commitment to building a differentiated portfolio that addresses meaningful patient needs.
Vinita Gupta, CEO of Lupin, noted that the tentative approval reflects the company's continued focus on developing medicines that solve specific clinical challenges. The move positions Lupin to capture demand in segments underserved by standard tablet formulations.
Manufacturing and operational readiness
Upon receiving final approval, the product will be manufactured at Lupin's facility in Somerset, New Jersey. This location leverages the company's U.S.-based manufacturing expertise to ensure high-quality standards and supply reliability for the American market.
| Detail | Information |
|---|---|
| Product | Apixaban Oral Suspension 1.25mg/mL |
| Regulatory Pathway | 505(b)(2) |
| Status | Tentative Approval |
| Manufacturing Site | Somerset, New Jersey |
About Lupin's global footprint
Lupin is a global pharmaceutical leader headquartered in Mumbai with products distributed in over 100 markets. The company maintains a diversified portfolio spanning generics, complex generics, specialty medicines, and biosimilars. It holds strong leadership positions in the U.S. and India across core therapeutic areas including cardiovascular, respiratory, diabetes, gastrointestinal, and women's health.
The company operates 15 state-of-the-art manufacturing facilities and employs over 26,000 professionals. Its infrastructure includes six research centers dedicated to sustainable operations and innovation in diagnostics, digital health, and patient-support programs.
Historical Stock Returns for Lupin
| 1 Day | 5 Days | 1 Month | 6 Months | 1 Year | 5 Years |
|---|---|---|---|---|---|
| -0.97% | -0.54% | -4.77% | -11.75% | +5.52% | 0.0% |
When is the final FDA approval expected for Lupin's Apixaban Oral Suspension, and what factors might influence this timeline?
How does the tentative approval impact Lupin's projected revenue growth from its US specialty portfolio in the upcoming fiscal quarters?
What competitive responses are anticipated from Bristol Myers Squibb or other generic manufacturers regarding the oral suspension formulation of apixaban?
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