Glenmark gets FDA nod for Theophylline Extended-Release Tablets generic

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Glenmark Pharmaceuticals has secured final approval from the US Food and Drug Administration (FDA) for Theophylline Extended-Release Tablets, 300 mg, and 450 mg.

The Indian pharma company’s Theophylline Extended-Release Tablets are bioequivalent and therapeutically equivalent to the reference listed drug – Theophylline Extended-Release Tablets, 300 mg, and 450 mg, owned by Alembic Pharmaceuticals.

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Theophylline extended-release tablets are used for treating symptoms and reversible airflow obstruction seen in chronic asthma, emphysema, chronic bronchitis, and other chronic lung diseases.

Glenmark Pharmaceuticals has been given a competitive generic therapy (CGT) designation for Theophylline Extended-Release Tablets USP, 450 mg. This makes the Indian pharma company the first approved applicant for such a type of competitive generic therapy.

Glenmark Pharmaceuticals gets FDA approval for Theophylline Extended-Release Tablets generic

Glenmark Pharmaceuticals gets FDA approval for Theophylline Extended-Release Tablets generic. Photo courtesy of The U.S. Food and Drug Administration/Wikipedia.org.

Glenmark Pharmaceuticals is eligible for 180 days of CGT exclusivity upon commercial marketing of the 450 mg dose.

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For the 12-month period ending April 2021, the Theophylline Extended-Release Tablets, 300 mg and 450 mg had annual sales of around $47.8 million, as per IQVIA sales data.

The current portfolio of Glenmark Pharmaceuticals features 173 products that are approved in the US and 44 ANDA’s waiting for approval from the FDA.

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Recently, the Indian pharma company launched Rufinamide Tablets USP, 200 mg and 400 mg in the US, the therapeutic equivalent of Eisai’s Banzel Tablets, 200 mg and 400 mg.

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