The product is bioequivalent to Mylan’s Yupelri inhalation solution and is indicated for the maintenance treatment of patients with Chronic Obstructive Pulmonary Disease (COPD). The referenced product had estimated annual sales of $260.7 million in the US, based on IQVIA MAT March 2026.
Last week, Lupin said it had received approval from the United States Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for famotidine injection USP, 20 mg/2 mL (10 mg/mL), single-dose vials. The product is bioequivalent to the reference listed drug (RLD), Pepcid injection, 10 mg/mL, manufactured by Merck Sharp & Dohme Corp.Also Read: Lupin shares may react to record US sales in Q4, strong operating performance
Famotidine injection USP, 20 mg/2 mL (10 mg/mL) is indicated for intravenous use in certain hospitalised patients with pathological hypersecretory conditions or intractable ulcers. It is also used as an alternative to oral dosage forms for short-term use in patients who are unable to take oral medication.
The drug is prescribed for short-term treatment of active duodenal ulcer, active benign gastric ulcer, gastroesophageal reflux disease (GERD), maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer, and treatment of pathological hypersecretory conditions such as Zollinger-Ellison Syndrome and multiple endocrine adenomas.
The product will be manufactured at Lupin’s Nagpur facility in India. Famotidine Injection had estimated annual sales of $8.7 million in the United States, according to IQVIA MAT March 2026 data.
Also Read: Lupin shares may react to record US sales in Q4, strong operating performance
Shares of Lupin Ltd ended at ₹2,248.00, down by ₹25.90, or 1.14%, on the BSE.
(Edited by : Jomy Jos Pullokaran)
First Published: May 18, 2026 11:08 PM IST
