Cipla gains on USFDA approval for Nexium generic

Cipla rose 1.88% to Rs 383.80 after the company said it received US drug regulator's final approval for generic version of AstraZeneca Pharmaceutical's Nexium.

In an exchange filing made before market hours today, Cipla said it received final approval for its abbreviated new drug application (ANDA) for Esomeprazole for oral suspension 10mg, 20mg and 40mg from the United States Food and Drug Administration (USFDA). Cipla is the first company to file for the 10mg strength.

Cipla's Esomeprazole for oral suspension 10mg, 20mg and 40mg is AB-rated generic therapeutic equivalent version of AstraZeneca Pharmaceutical's Nexium.

Nexium is a proton pump inhibitor indicated for treatment of gastroesophageal reflux disease (GERD), reducing risk of NSAID-associated gastric ulcer, eradication of helicobacter pylori (H. pylori) bacteria to reduce the risk of duodenal ulcer recurrence and for pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

According to IQVIA (IMS Health), Nexium and its generic equivalents had US sales of approximately $70 million for the 12-month period ending November 2019. The product is available for shipping immediately.

Cipla is a global pharmaceutical company focused on complex generics. The company's strengths lay in the respiratory, anti-retroviral, urology, cardiology, anti-infective and central nervous system (CNS) segments.

On a consolidated basis, the drug maker's net profit rose 5.7% to Rs 351.03 crore on a 8.4% increase in net sales to Rs 4234.55 crore in Q3 December 2019 over Q3 December 2018.

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