Lupin Secures Us Fda Approval For Tolvaptan Tablets, Eyeing Nephrology Market

SUMMARY

Lupin Limited connected Thursday said it received support from nan United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Tolvaptan tablets successful 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg strengths.

Tolvaptan tabs are bioequivalent to Jynarque tablets from Otsuka Pharmaceutical Company. This support positions Lupin arsenic nan exclusive first-to-file manufacturer, granting it 180 days of generic supplier exclusivity. The tablets will beryllium produced astatine Lupin’s Nagpur installation successful India, pinch plans for a forthcoming launch.

Tolvaptan is utilized to negociate kidney usability diminution successful adults who are astatine consequence of quickly progressing autosomal ascendant polycystic kidney illness (ADPKD).

The US marketplace for Tolvaptan tablets is significant, pinch estimated yearly income reaching $1,467 cardinal arsenic of nan fiscal twelvemonth ending December 31, 2024. This improvement is portion of Lupin's strategy to fortify its foothold successful nan nephrology sector, addressing a captious area of diligent need.

Vinita Gupta, CEO of Lupin, expressed restitution pinch this regulatory milestone, stating: "We are very pleased to person obtained support for generic Tolvaptan from nan US FDA. This marks a important introduction into nan nephrology conception and demonstrates our committedness to addressing nan unmet needs of patients globally." Lupin's attraction connected expanding its merchandise portfolio successful targeted areas is evident successful this strategical move.

The support of Tolvaptan tablets further underscores Lupin's dedication to providing affordable healthcare solutions globally. With nan manufacturing group successful India, nan institution is poised to leverage its accumulation capabilities while entering nan lucrative US generic market.

This improvement is expected to person affirmative implications for Lupin's marketplace position and its ongoing efforts to present high-quality, accessible medicines.

Lupin shares were past seen trading 0.78 per cent higher astatine Rs 2,105.10.

Published on: Apr 24, 2025 12:56 PM IST