| US Market Size | $52.3MIQVIA MAT Aug 2026 |
|---|---|
| Market Cap | ₹88,572.5 CrLarge Cap |
| TTM P/E Ratio | 16.02xSector: 47.26x |
| RSI | 31.95Near Oversold |
Key highlights
- U.S. FDA approval for Phytonadione Injectable Emulsion USP (1 mg/0.5 mL) in single-dose prefilled syringes
- Targets an estimated U.S. annual market size of USD 52.3 million as of August 2026
- Indicated for treatment and prophylaxis of hypoprothrombinemia and vitamin K deficiency
- Product is bioequivalent to the reference listed drug (RLD) from International Medication Systems, Limited
- Part of a pipeline with 429 cumulative ANDA filings as of June 30, 2026
New Therapeutic Offering for the U.S. Market
Lupin Limited has secured approval for Phytonadione Injectable Emulsion USP, which is used for treating low blood clotting and vitamin K deficiency. The product, delivered as a 1 mg/0.5 mL single-dose prefilled syringe, has been identified as bioequivalent to the reference listed drug from International Medication Systems, Limited. This approval addresses a specialized segment of the pharmaceutical market, with IQVIA data estimating the annual U.S.
sales for this emulsion at USD 52.3 million as of August 2026. This move aligns with Lupin's strategy to expand its complex generic and specialty portfolio in the United States.
Sustained Momentum in Regulatory Approvals
- Received tentative U.S. FDA approval for Apixaban Oral Suspension (1.25 mg/mL) on September 28, 2026
- Obtained approval for Modafinil Tablets USP (100 mg and 200 mg) on September 04, 2026
- Secured final approval for Pitolisant Tablets (4.45 mg and 17.8 mg) on August 17, 2026
- Granted approval for Sodium Zirconium Cyclosilicate for Oral Suspension on August 10, 2026
- Achieved approval for Sugammadex Injection (200 mg/2 mL and 500 mg/5 mL) on July 31, 2026
- Cumulative U.S. FDA filings reached 429 ANDAs with 350 approvals as of June 30, 2026
Strong Financial Backdrop and Performance
The approval comes at a time when Lupin is showing robust growth in its core pharmaceutical operations. For the quarter ended June 30, 2026, the company reported operating revenue of ₹8,276.89 crore, representing a 32.04% increase year-on-year. Net profit for the same period stood at ₹1,415 crore.
The company maintains an operating profit margin of 29.6%, a notable improvement from 27.6% recorded four quarters ago. With 15 state-of-the-art manufacturing facilities and six research centers, the company is leveraging its infrastructure to maintain leadership across cardiovascular, respiratory, and diabetic therapeutic areas.
| Date | Announcement | Amount |
|---|---|---|
| 28 Sep 2026 | U.S. FDA tentative approval for New Drug Application for Apixaban Oral Suspension, 1.25 mg/mLSource: lupin.com | – |
| 04 Sep 2026 | U.S. FDA approval for Abbreviated New Drug Application for Modafinil Tablets USP, 100 mg and 200 mgSource: lupin.com | – |
| 17 Aug 2026 | U.S. FDA final approval for Abbreviated New Drug Application for Pitolisant Tablets, 4.45 mg and 17.8 mgSource: lupin.com | – |
| 10 Aug 2026 | U.S. FDA approval for Abbreviated New Drug Application for Sodium Zirconium Cyclosilicate for Oral Suspension, 5 g/packet and 10 g/packetSource: lupin.com | – |
| 31 Jul 2026 | U.S. FDA approval for Abbreviated New Drug Application for Sugammadex Injection, 200 mg/2 mL and 500 mg/5 mL Single-Dose VialsSource: lupin.com | – |
| 26 Jun 2026 | U.S. FDA tentative approval for Abbreviated New Drug Application for Enzalutamide Tablets, 40 mg, 80 mg, 120 mg, and 160 mgSource: lupin.com | – |
What to watch next
- Commercial launch of biosimilar Pegfilgrastim in the U.S. targeted for H2 FY27
- Declaration of Q2 FY27 financial results scheduled by mid-November 2026
- Progress of the 50 first-to-file filings currently in the U.S. pipeline
| Share price | ₹1936.9 |
|---|---|
| Market capitalisation | ₹88,572.50 Cr |
| Revenue (annual) | ₹27,958.03 Cr |
| Net profit (annual) | ₹5,332.84 Cr |
| Revenue (latest quarter) | ₹8,276.89 Cr+10.73% vs previous quarter |
| Net profit (latest quarter) | ₹1,415.00 Cr-3.10% vs previous quarter |
| P/E (TTM) | 16.02×Sector 47.26× |
| Promoter holding | 46.85%-0.01% QoQ |
| FII holding | 22.42%Current quarter |
Reference market data from a third-party provider, as of the story. Not a valuation or a recommendation.
Exchange filing by Lupin Limited announcing U.S. FDA approval for Phytonadione Injectable Emulsion USP. Market figures from a third-party data provider.
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