Glenmark Pharma gets final nod from USFDA for Theophylline ER tablets

PTI New Delhi | Updated on June 04, 2021

Eligible for 180 days of competitive generic therapy exclusivity for commercial marketing of 450 mg strength

Glenmark Pharma on Friday said it has received final approval from the US health regulator for Theophylline extended-release (ER) tablets.

Theophylline extended-release tablets are used to prevent and treat wheezing, shortness of breath, and chest tightness caused by asthma, chronic bronchitis, emphysema, and other lung diseases.

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In a regulatory filing Glenmark Pharmaceuticals said it has received final approval from the United States Food and Drug Administration (USFDA) for Theophylline extended-release tablets in the strengths of 300 mg and 450 mg.

Glenmark said it has been granted a competitive generic therapy (CGT) designation for Theophylline extended-release tablets USP, 450 mg.

"With this approval, Glenmark is the first approved applicant for such competitive generic therapy and is eligible for 180 days of CGT exclusivity upon commercial marketing of the 450 mg strength," the filing said.

Quoting IQVIA sales data for the 12-month period ending April 2021, the Theophylline extended release tablets, 300 mg and 450 mg market achieved annual sales of approximately $47.8 million.

Glenmark’s current portfolio consists of 173 products authorised for distribution in the US marketplace and 44 abbreviated new drug applications pending approval with the USFDA.

Published on June 04, 2021

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