Strides Pharma Science Ltd, a prominent global pharmaceutical company, announced that its subsidiary, Strides Pharma Global Pte Ltd, Singapore, has secured approval from the US Food & Drug Administration (USFDA) for its generic version of Theophylline extended-release tablets. These tablets, available in 300 mg and 450 mg dosages, are used to manage respiratory conditions such as chronic asthma, emphysema, and chronic bronchitis. This approval signifies a major milestone for Strides Pharma as it allows the company to enter the competitive US market with its bioequivalent product.
Key Benefits of Theophylline Extended-Release Tablets
Theophylline is a bronchodilator, meaning it helps to open airways and improve airflow in patients suffering from respiratory conditions. It is particularly effective for managing symptoms of reversible airflow obstruction, which is commonly seen in patients with chronic asthma and other lung diseases like emphysema and chronic bronchitis.
The newly approved generic version by Strides Pharma is bioequivalent and therapeutically equivalent to THEO-DUR, the branded version of Theophylline extended-release tablets manufactured by Schering Corp. Bioequivalence means that Strides’ version delivers the same amount of active ingredients to the bloodstream in the same time frame as the original drug, ensuring similar safety and efficacy profiles.
Manufacturing and Market Potential
Strides Pharma will produce these Theophylline extended-release tablets at its flagship facility in KRS Gardens, Bengaluru, which is known for adhering to the highest standards of quality in pharmaceutical manufacturing. Theophylline extended-release tablets (300 mg and 450 mg) have a combined market value of approximately USD 11.5 million, according to IQVIA data. The approval allows Strides Pharma to tap into this market, providing a more affordable alternative to patients in the US who rely on Theophylline for long-term respiratory management.
Theophylline is a xanthine derivative, classified as a bronchodilator, used primarily for the treatment of chronic asthma and chronic obstructive pulmonary diseases (COPD). It works by relaxing the muscles in the lungs, which helps improve breathing. Theophylline is particularly useful in patients who require long-term control of their asthma or COPD symptoms.
These extended-release tablets offer a prolonged effect, ensuring better control over symptoms with fewer doses. In the treatment of chronic asthma, it is often used in conjunction with other drugs like inhaled corticosteroids to manage inflammation and control asthma symptoms effectively.
Impact of Strides Pharma’s Generic Entry
By receiving USFDA approval, Strides Pharma is poised to contribute to the US healthcare market by offering a cost-effective alternative to the branded version of Theophylline. For many patients, the high cost of medication can be a barrier to long-term treatment adherence, especially for chronic conditions like asthma, where ongoing management is crucial. Strides Pharma’s generic alternative aims to reduce this financial burden without compromising the quality or effectiveness of the treatment.
This move aligns with Strides Pharma’s strategic focus on expanding its presence in the regulated markets and offering affordable healthcare solutions worldwide. The US market, being one of the most lucrative pharmaceutical markets globally, presents a significant opportunity for the company to grow its portfolio of approved products and make its mark as a leading provider of generic medications.
A Step Toward Affordable Respiratory Care
The introduction of Strides Pharma’s Theophylline extended-release tablets will bring relief to patients suffering from chronic respiratory diseases, who depend on reliable, affordable medication for symptom management. With a global push toward making healthcare more accessible, this approval is a significant step in enhancing treatment options for patients in need.
(Input from various sources)
(Rehash/Ankur Deka/MSM)
