Lupin receives FDA nod for 3 generics

Lupin recently received the Food and Drug Administration’s blessing for three generics.

Lupin has received permission from the FDA for Loteprednol Etabonate Ophthalmic Suspension, 0.2%, which is the generic of Bausch & Lomb’s Alrex. 

Loteprednol Etabonate Ophthalmic Suspension, 0.2%, is indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis.

Loteprednol Etabonate Ophthalmic Suspension, 0.2% (RLD Alrex), had a market value of roughly $29.1 million, per IQVIA October 2023 data.

Lupin also has obtained the FDA’s clearance for Allopurinol Tablets, 100 mg and 300 mg, which is the generic of Casper Pharma’s Zyloprim. 

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

Allopurinol Tablets are indicated for the management of:

• Adult patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy);
• Adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels; and
• Adult patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients, despite lifestyle changes. 

Allopurinol Tablets (RLD Zyloprim) had a market value of roughly $88.1 million, per IQVIA October 2023 data.

Lupin also has received the FDA’s green light for Sitagliptin Tablets, 25 mg, 50 mg, and 100 mg, which is a generic of Merck’s Januvia. 

Sitagliptin Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in patients with Type 2 diabetes mellitus.

Sitagliptin Tablets (RLD Januvia) had a market value of approximately $5.8 billion, per IQVIA October 2023 data.

The three new generics will be manufactured at Lupin’s Pithampur facility in India.