Lupin Gets USFDA Nod for UCD Drug; Market Size $337 Million

Lupin Limited has received approval from the United States Food and Drug Administration for its Abbreviated New Drug Application for Glycerol Phenylbutyrate Oral Liquid, 1.1 grams per mL. This approval marks a significant addition to Lupin’s portfolio in the US pharmaceutical market.

Bioequivalence to Reference Drug

The approved product is bioequivalent to the reference listed drug Ravicti Oral Liquid, developed by Horizon Therapeutics U.S. Holding LLC. Bioequivalence ensures that the generic version matches the branded drug in terms of dosage, safety, strength, and efficacy.

This allows Lupin to offer a cost-effective alternative in the market while maintaining the same therapeutic benefits.

Indication and Medical Use

Glycerol Phenylbutyrate Oral Liquid is indicated for the chronic management of patients suffering from urea cycle disorders (UCDs). These are rare genetic conditions that impair the body’s ability to remove ammonia from the bloodstream.

The drug is particularly used in cases where the condition cannot be effectively managed through dietary protein restriction or amino acid supplementation alone, making it a critical treatment option for patients.

Market Opportunity

According to industry data, the reference drug recorded sales of approximately $337 million for the year ended December 2025. This highlights a sizeable market opportunity for Lupin as it enters the segment with its approved generic version.

The approval is expected to strengthen Lupin’s presence in the US generics market, especially in specialised therapeutic areas.

Lupin Share Price Today

On May 5, 2026, Lupin share price opened at ₹2,354.00, touching the day’s low at ₹2,334.00, as of 11:58 AM on the NSE.

Also Read: Lupin Pharmaceuticals Arm to Settle Antitrust Case with Humana for $30 Million!

Conclusion

The USFDA approval represents a strategic milestone for Lupin, enabling it to tap into a niche yet high-value market. With a focus on complex generics and specialty treatments, the company continues to expand its footprint in global pharmaceutical markets while addressing critical patient needs.

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