- Strides is the “first approved applicant” and is eligible for 180 days of Competitive Generic Therapy (CGT) exclusivity for Theophylline Extended-Release Tablets, 300 mg
Bangalore, India, September 6, 2024 – Strides Pharma Science Limited (Strides) today announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for the generic version of Theophylline Extended-Release Tablets, 300 mg and 450 mg, from the United States Food & Drug Administration (USFDA).
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), THEO-DUR®, of Schering Corp. Theophylline extended-release tablets are indicated for the treatment of symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis.
Theophylline Extended-Release Tablets, 300 mg and 450 mg have a combined market size of ~US$ 11.5 mn, with the 300 mg dosage contributing ~US$ 10.8 mn as per IQVIA. The Theophylline Extended-Release Tablets, 300 mg and 450 mg will be manufactured at the company’s flagship facility in KRS Gardens in Bangalore, India.
