Lupin receives nod for generic Adderall XR, launches generic Bumex

Lupin is busy on the generics front. The company has received approval from the Food and Drug Administration for a new generic and the company is rolling out a new generic product.

Lupin has received the FDA’s nod for dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules (mixed salts of a single entity amphetamine product), 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg, which is a generic of Takeda’s Adderall XR Extended-Release capsules. 

Generic Adderall will be manufactured at Lupin’s Somerset facility in the United States.

Generic Adderall XR capsules are indicated for the treatment of attention deficit hyperactivity disorder in adults and pediatric patients 6 years and older.

[Read more: Lupin receives FDA OK for generic Banzel]

The product had a market value of roughly $865 million, per IQVIA September 2024 data.

After receiving FDA approval, Lupin is launching bumetanide injection, 1 mg/4 ml (0.25 mg/ml) single-dose vials and 2.5 mg/10 ml (0.25 mg/ml) multiple-dose vials, which is a generic of Validus Pharmaceuticals’ Bumex Injection. The product is indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome.

Bumetanide Injection (RLD Bumex) had a market value of roughly $20 million, per IQVIA  September 2024 data.

[Read more: Lupin rolls out generic Doxil]