Glenmark Pharma trades flat despite getting USFDA nod for Theophylline ER tablets

Glenmark Pharmaceuticals Ltd, a leading pharmaceutical company, announced today that it has received USFDA approval for Theophylline extended-release (ER) tablets of strengths 300 mg & 450 mg.   

These tablets are bioequivalent and therapeutically equivalent to Theophylline extended-release tablet (of strengths 300 mg & 450 mg), a reference-listed drug (RLD) of Alembic Pharmaceuticals Limited.   

Theophylline extended-release tablet is a bronchodilator. It helps in opening up the airways in the lungs for making it easier to breathe. This medicine is used to treat the symptoms of asthma, bronchitis & emphysema.  

The pharma company has received a competitive generic therapy (CGT) designation for Theophylline extended-release tablets USP of strength 450 mg. With this grant, it becomes the first-approved applicant for such a competitive generic therapy. This makes the company eligible for CGT exclusivity for the tenure of 180 days upon commercial marketing of the 450 mg strength.   

As per the sales data of IQVIA, Theophylline ER tablets of strengths 300 mg & 450 mg had annual sales of approximately $47.8 million during a 12-month period ending April 2021.  

With this approval, Glenmark’s product portfolio now comprises 173 products, which are authorized for distribution in the US marketplace. It also has 44 ANDAs (abbreviated new drug applications) that are pending approval with USFDA.   

At 1.53 pm, the share price of Glenmark Pharmaceuticals Ltd was trading at Rs 613.60, down by 0.43 per cent over its previous day’s closing price of Rs 616.25 on BSE.