Lupin secures tentative FDA approval for Xywav oral solution generic

Global pharma leader, Lupin Limited, proudly announced its tentative approval from the United States Food and Drug Administration (U.S. FDA). This nod gives green light to its Abbreviated New Drug Application for Calcium, Magnesium, Potassium, and Sodium Oxybates Oral Solution, 0.5 g/mL. Aiming to tap into the lucrative market, Lupin’s product is set to be a generic counterpart to Xywav Oral Solution, 0.5 g/mL of Jazz Pharmaceuticals Ireland Limited.

Lupin’s US Somerset Facility Gears Up for Production

Highlighting its manufacturing prowess, Lupin has identified its Somerset facility in the US as the prime location for producing the newly approved generic solution. This strategic decision positions Lupin to swiftly cater to the US market, leveraging its established infrastructure.

Exclusive First-to-File Rights and Potential 180-Day Exclusivity for Lupin

Lupin stands out with its exclusive first-to-file status, potentially allowing the pharma major a golden 180-day exclusivity period during its product launch. This exclusivity could provide Lupin with a significant competitive edge in the pharmaceutical market.

Stellar Sales Forecast for Lupin’s Generic Oral Solution

The financial potential for Lupin’s Calcium, Magnesium, Potassium, and Sodium Oxybates Oral Solution (RLD Xywav) is evident. The product reported a commendable net product sales of USD 958.4 million for the year ending December 2022. The momentum doesn’t stop there, as the sales skyrocketed to USD 604.3 million just in the first half of 2023, pointing towards a promising future for Lupin’s venture.