LUPIN · Lupin Limited · BSE · Filed 8 Oct · 1 min read

Lupin Gets U.S. FDA Approval for Phytonadione Injectable Emulsion

The company said the FDA approved its ANDA for a vitamin K injectable used to treat and prevent low blood clotting.

What was approved

Lupin said, in a press release filed under Regulation 30, that it has received U.S. FDA approval for its Abbreviated New Drug Application (ANDA) for Phytonadione Injectable Emulsion USP, supplied as a single-dose prefilled syringe. Per the filing, the product was approved as bioequivalent to the reference listed drug of International Medication Systems, Limited.

The product and its use

The company said the injectable is indicated for the treatment and prophylaxis of hypoprothrombinemia (low blood clotting) and vitamin K-deficiency. The approval adds another injectable generic to a U.S. portfolio the filing describes as spanning generics, complex generics, specialty medicines and biosimilars across core therapeutic areas.

Why it matters to a holder

The filing cites an IQVIA-estimated figure for the molecule's annual U.S. sales, which gives a sense of the market the approval opens. It does not state Lupin's own expected share, launch timing, or revenue contribution, so this is an incremental product clearance rather than a company-wide event.

Estimated annual U.S. sales of the molecule: USD 52.3 million
Strength / presentation: 1 mg/0.5 mL Single-dose Prefilled Syringe

The approval clears Lupin to market another injectable generic in the U.S.; the filing quantifies the molecule's addressable market but does not disclose expected sales, share, or launch timing, so the earnings impact is not stated.