Lupin wins FDA approval for generic vitamin K injection with $52.3M U.S. market
Lupin Limited received FDA approval on October 8, 2026, for its Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL single-dose prefilled syringe. The product is bioequivalent to International Medication Systems' reference drug and had estimated annual U.S. sales of USD 52.3 million.
Lupin Limited said on this date that the U.S. FDA had approved its Abbreviated New Drug Application for Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-dose Prefilled Syringe.12
The FDA found Lupin's prefilled syringe bioequivalent to the reference listed drug Phytonadione Injectable Emulsion, 1 mg/0.5 mL, from International Medication Systems, Limited.12
IQVIA MAT August 2026 put estimated annual U.S. sales of Phytonadione Injectable Emulsion at this level, indicating the size of the market the approved generic would compete in.2
Story
Lupin's FDA Approval for Phytonadione Injectable EmulsionLupin Limited announced on October 8, 2026, that the U.S. Food and Drug Administration approved its Abbreviated New Drug Application for Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-dose Prefilled Syringe.12 The approval covers a generic injectable form of vitamin K, a product that had estimated annual sales of USD 52.3 million in the United States, according to IQVIA MAT August 2026.2 That figure represents the size of the market Lupin is entering with this approval.2 The product is indicated for the treatment and prophylaxis of hypoprothrombinemia, or low blood clotting, and vitamin K-deficiency.12
The FDA approved Lupin's product as bioequivalent to the reference listed drug Phytonadione Injectable Emulsion, 1 mg/0.5 mL, of International Medication Systems, Limited.12 That bioequivalence finding means Lupin's version is a generic alternative to the International Medication Systems product.1 The reference drug and Lupin's product share the same strength and volume: 1 mg/0.5 mL.12 The approval was granted through the Abbreviated New Drug Application pathway, which is used for generic versions of already-approved drugs.12
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India.12 It has a strong presence across India, the U.S., Other Developed Markets, and Emerging Markets, and its products are distributed in over 100 markets.12 The company's portfolio spans generics, complex generics, specialty medicines, and biosimilars.12 In the U.S. and India, Lupin holds leading positions in several core therapeutic areas, such as cardiovascular, respiratory, diabetes, gastrointestinal, and women's health.12
Lupin operates 15 state-of-the-art manufacturing facilities and 6 research centers, and it employs more than 26,000 professionals.12 These resources support its global reach and its ability to bring products like the newly approved phytonadione injection to market.1 The company is broadening its healthcare offerings to include diagnostics, digital health, patient-support programs, and disease management initiatives.12 Sustainability continues to be a core pillar of Lupin's business strategy.12
The approval is for a single-dose prefilled syringe, a format that can simplify administration for healthcare providers.12 The product is intended for patients with hypoprothrombinemia, a condition of low blood clotting, and for those with vitamin K-deficiency.12 The estimated annual U.S. sales of USD 52.3 million, based on IQVIA data for the period ending August 2026, indicate the commercial scale of the market for this product.2 That figure is a measure of the market Lupin's generic will compete in, not a projection of Lupin's own sales.2
The FDA's bioequivalence determination is central to the approval, as it confirms that Lupin's product is an appropriate substitute for the reference drug.12 The reference listed drug is Phytonadione Injectable Emulsion, 1 mg/0.5 mL, from International Medication Systems, Limited.12 Lupin's approved product matches that strength and volume exactly.12 The approval was announced on October 8, 2026, by Lupin Limited.12
Lupin's global footprint includes products distributed in more than 100 markets, supported by 15 manufacturing facilities and 6 research centers.12 The company employs over 26,000 professionals.12 Its therapeutic strengths in the U.S. and India cover cardiovascular, respiratory, diabetes, gastrointestinal, and women's health.12 The new approval adds to a portfolio that already includes generics, complex generics, specialty medicines, and biosimilars.12
The market for Phytonadione Injectable Emulsion in the U.S. was estimated at USD 52.3 million annually, according to IQVIA MAT August 2026.2 That estimate reflects sales of the product category, not Lupin's potential share.2 The approval gives Lupin a generic alternative in a market that already has an established reference product.12 The product is indicated for low blood clotting and vitamin K-deficiency, conditions that require reliable treatment options.12
Lupin's business strategy also includes broadening its healthcare offerings to include diagnostics, digital health, patient-support programs, and disease management initiatives.12 Sustainability remains a core pillar of that strategy.12 The company's scale, with over 26,000 employees and 15 manufacturing facilities, supports its ability to supply products across more than 100 markets.12 The approval of the phytonadione injection is part of that broader global pharmaceutical operation.12
The FDA approval was granted for Lupin's Abbreviated New Drug Application for Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-dose Prefilled Syringe.12 The product is bioequivalent to the reference listed drug from International Medication Systems, Limited.12 It is indicated for the treatment and prophylaxis of hypoprothrombinemia and vitamin K-deficiency.12 The estimated annual U.S. sales of USD 52.3 million, per IQVIA MAT August 2026, provide context for the market opportunity.2
Structure
Who is connected to whom- 1Lupin Limited
- located in →Fact
History
How it came to this- Before October 8, 2026Lupin files an Abbreviated New Drug Application for phytonadione injectionLupin sought FDA approval of a generic version of Phytonadione Injectable Emulsion, 1 mg/0.5 mL, through the abbreviated pathway used for generics of already-approved drugs.
- October 8, 2026FDA approves Lupin's phytonadione injectionThe FDA approved Lupin's Abbreviated New Drug Application for Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-dose Prefilled Syringe, finding it bioequivalent to the reference listed drug from International Medication Systems, Limited.
- NowUSD 52.3 million Estimated annual U.S. sales of Phytonadione Injectable Emulsion
Impact
Spreading outward, level by level- Level 1U.S. market for phytonadione injectable emulsion
The approval adds a generic alternative in a U.S. product category with estimated annual sales of USD 52.3 million, according to IQVIA MAT August 2026.2
Fact - Level 2Patients needing vitamin K therapy
The approved product is indicated for the treatment and prophylaxis of hypoprothrombinemia, or low blood clotting, and vitamin K-deficiency.12
Fact - Level 3Substitution for the reference product
Because the FDA found Lupin's product bioequivalent to the reference listed drug, it is a generic alternative to International Medication Systems, Limited's product.12
Fact - Level 4Lupin's U.S. generics business
The approval adds to a portfolio that already spans generics, complex generics, specialty medicines, and biosimilars, and to Lupin's leadership in core therapeutic areas in the U.S. and India.12
Fact - Level 5Lupin's global supply and reach
Lupin's 15 manufacturing facilities, 6 research centers, and more than 26,000 employees support distribution in over 100 markets, which may help it supply the newly approved product.
Analysis
Sources
What each source supportsWritten by AI from the sources listed below: every fact was checked word for word against its source, and inference is marked apart. How we write