Lupin Expands U.S. Portfolio with Authorized Generic Launch of Ravicti

Mumbai-headquartered Lupin Limited announced the launch of its authorized generic version of Ravicti (glycerol phenylbutyrate) oral solution in the U.S. market. The medication, approved by the U.S. Food and Drug Administration (FDA), is used for chronic management of urea cycle disorders (UCDs)—rare metabolic diseases requiring strict nitrogen control.

Lupin’s latest launch expands its presence in niche therapy areas and reinforces its leadership in complex generics. The authorized generic has been launched under a commercial agreement with Horizon Therapeutics, offering U.S. patients an affordable treatment alternative without compromising on quality, efficacy, or safety. Lupin continues to position itself as a key supplier in the rare disease segment while diversifying its U.S. product portfolio.

Market experts estimate that the total annual U.S. sales for Ravicti exceeded USD 340 million, underlining the commercial and strategic significance of this launch.

Notable Updates:

Lupin launches authorized generic of Ravicti in the U.S. market.

Approved by U.S. FDA for treating urea cycle disorders (UCD).

Manufactured at Lupin’s U.S. FDA-approved Nagpur facility.

Strengthens Lupin’s complex generics and specialty product pipeline.

U.S. annual sales for Ravicti estimated at USD 340 million (IQVIA data).

Sources: Lupin Press Release, U.S. FDA Database, Moneycontrol Pharma News, PR Newswire.