Senores Pharmaceuticals Limited has announced that it has received final approval from the United States Food and Drug Administration (USFDA) for the marketing of Metoprolol Tartrate and Hydrochlorothiazide Tablet USP in strengths of 50 mg/25 mg and 100 mg/25 mg. This approval positions the company to address hypertension treatment in the U.S. market, providing an opportunity to expand its market presence in a segment with limited competition.
Key Details:
- Product Overview: The tablets combine Metoprolol Tartrate, a beta adrenoceptor blocker, with Hydrochlorothiazide (HCTZ), a thiazide diuretic. The combination is indicated for treating hypertension, reducing the risk of cardiovascular events such as strokes and myocardial infarctions.
- Market Size: According to IQVIA and Symphony sales data for the 12 months ending November 2024:
- 50 mg/25 mg tablets accounted for approximately $6 million in annual sales.
- 100 mg/25 mg tablets generated around $10 million in sales.
- Portfolio Strength: With this approval, Senores now has 24 ANDA products approved for distribution in the U.S. The company is also seeking external collaborations to accelerate the development of its existing pipeline.
Management Commentary:
Swapnil Shah, Managing Director of Senores Pharmaceuticals, stated, “This approval underscores our commitment to enhancing our product portfolio with specialty and complex pharmaceutical formulations. Metoprolol Tartrate and Hydrochlorothiazide are niche formulations, and with limited competition in the U.S., we aim to capture a significant market share.”
About Senores Pharmaceuticals:
Senores Pharmaceuticals Limited specializes in developing and manufacturing complex pharmaceutical products for regulated and emerging markets. The company’s U.S.-based subsidiary, Senores Pharmaceuticals, Inc., is one of the fastest-growing pharmaceutical firms in the region.
