Tolvaptan is indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Rexulti Tablets
Tolvaptan Tablets (RLD Jynarque) had estimated annual sales of USD 287 million in the U.S. (IQVIA MAT August 2023)
Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, (RLD Rexulti) had estimated annual sales of US $1,575 million in the US (IQVIA MAT December 2022)
Companies finalize termination with an agreed-upon settlement fee of $55M to be paid to Akebia
The product will be commercialized from Unichem's Ghaziabad plant
This product will be manufactured at Lupin’s Pithampur facility In India
Subscribe To Our Newsletter & Stay Updated
