Glenmark announced on 16 November 2018 that it had gained US Food and Drug Administration (FDA) approval on 15 November 2018 for its teriflunomide tablets, 7 mg and 14 mg. Glenmark’s product is a generic version of MS treatment Aubagio (teriflunomide) made by Sanofi-Aventis.

According to IQVIA sales data for the 12-month period ending September 2018, Aubagio tablets in dosages of 7 mg and 14 mg market had annual sales of approximately US$1.6 billion.

Then on 22 November 2018, Glenmark announced that it had received FDA approval on 21 November 2018 for its atovaquone oral suspension USP*, 750 mg/5 mL. Glenmark’s product is a generic version of GlaxoSmithKline’s pneumonia treatment Mepron.

According to IQVIA sales data, the Mepron had annual sales of approximately US$119.1 million.

Glenmark says that its current portfolio includes 144 products authorized for distribution in the US and 55 abbreviated new drug applications (ANDAs) pending approval with FDA.

*A USP mark on a medicine indicates to pharmacists, medical practitioners and patients that the product has been made in accordance with the quality standards of the US Pharmacopeia. The US Pharmacopeia is a reference of uniform preparations for the most commonly used drugs – with tests to ensure their quality, potency and purity.

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