Pharma Major Lupine Ltd in Thorsday said he has received an approach to the United States Health Regulator for his generic version or indicated hopptán tablets for a certain type of kidney disease.
The approval of the United States Food and Medicines Administration (USFDA) is for the application for abbreviated medications of tablets or strengths of 15 mg, 30 mg, 45 mg, 60 mg and 90 mg, Lupin said in a regulatory presentation.
These are bioequivalent to the Jynarque tablets in the same strengths of otuka Pharmaceutical Company Ltd, he added.
“Lupin is the exclusive first in the file for this product and is eligible for 180 days of generic exclusive drugs. This product will be manufactured at Lupin facilities in Nagpur and will be launched soon,” said the company.
When commenting on the approach, Lupin’s CEO, Vinita Gupta, said: “This marks a significant entry in the nephrology segment and demonstrates our commitment to address the unattered needs of patients worldwide.” The hopptán is indicated for the slow decrease in renal function in adults at risk that autosomal dominant polycystic disease progresses rapidly (ADPKD), he said.
These tablets had an estimated annual sale of $ 1,467 million in the US. In 2024.
Posted on April 24, 2025