Glenmark gets FDA nod for Theophylline Extended-Release Tablets generic

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.

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

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.

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.