Last Updated on December 22, 2024 by The Health Master
USFDA approval
Glenmark Specialty SA (Glenmark) has a reason to celebrate! They’ve secured final U.S. Food and Drug Administration approval (USFDA approval) for their Esomeprazole Magnesium delayed-release capsules USP, 20 mg (OTC).
This medication offers much-needed relief for heartburn sufferers and is poised to become a major player in the rapidly growing OTC heartburn treatment market.
Bioequivalent to Leading Brand Nexium 24HR
The USFDA has determined that Glenmark’s Esomeprazole Magnesium capsules are bioequivalent to Nexium 24 HR Delayed-Release Capsules, 20 mg (OTC), a leading brand from Haleon U.S. Holdings LLC.
This means both medications deliver the same amount of the active ingredient (esomeprazole) into the bloodstream at the same rate, ensuring comparable effectiveness in treating heartburn.
Entering the Lucrative OTC Heartburn Market
With ANDA (Abbreviated New Drug Application) USFDA approval in hand, Glenmark’s Esomeprazole Magnesium capsules are now cleared for entry into the vast U.S. OTC heartburn medication market.
This market is experiencing significant growth, with Nielsen syndicated data revealing annual sales of approximately $259.2 million for the Nexium 24 HR capsules alone (for the 52 weeks ending May 18, 2024).
This data suggests a significant opportunity for Glenmark to capture a sizeable share of this market.
Strong US Presence for Glenmark
Glenmark’s success with Esomeprazole Magnesium further strengthens their position in the U.S. pharmaceutical market.
They already boast an impressive portfolio of 197 USFDA-approved products and have 50 additional ANDA applications pending.
This robust pipeline demonstrates Glenmark’s commitment to expanding its U.S. presence and catering to diverse healthcare needs.
Overall, Glenmark’s USFDA approval for Esomeprazole Magnesium capsules is a significant development for both the company and consumers.
It offers patients a potentially more affordable alternative for treating heartburn while positioning Glenmark to capitalize on a lucrative market segment.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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