FDA gives Lupin tentative approval for generic Trijardy
Trijardy contains three diabetes medications: empagliflozin, linagliptin and metformin hydrochloride.
Lupin has received tentative approval from the Food and Drug Administration for empagliflozin, linagliptin and metformin hydrochloride extended-release tablets, 5 mg/2.5 mg/1,000 mg, 10 mg/5 mg/1,000 mg, 12.5 mg/2.5 mg/1,000 mg and 25 mg/5 mg/1,000 mg, which is a generic of Boehringer Ingelheim’s Trijardy.
The product, which is used to treat Type 2 diabetes in adult patients, will be manufactured at Lupin’s Pithampur facility in India.
[Read more: Lupin receives FDA OK for generic Banzel]
Empagliflozin, Linagliptin and Metformin Hydrochloride ER Tablets had an a market value of roughly $111million, per IQVIA April 2024 data.
[Read more: Lupin receives FDA nod for 3 generics]