Zenara Pharma Receives U.S. FDA Approval for First Generic of Sertraline Hydrochloride Capsules with 180-Day CGT Exclusivity
HYDERABAD, India, August 1, 2025 /PRNewswire/ -- Zenara Pharma Private Limited ("Zenara"), a Biophore company, today announced that it has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Sertraline Hydrochloride Capsules, 150 mg and 200 mg. This approval marks the first FDA-approved generic equivalent of the reference listed drug marketed by Almatica Pharma, LLC.
The product has also been granted Competitive Generic Therapy (CGT) designation by the FDA. As the first approved applicant under this pathway, Zenara's ANDA has secured 180 days of marketing exclusivity in the U.S., which commenced with the product's launch1.
Sertraline Hydrochloride Capsules are classified as selective serotonin reuptake inhibitors (SSRIs) and are indicated for the treatment of Major Depressive Disorder (MDD) in adults and Obsessive-Compulsive Disorder (OCD) in adults and pediatric patients aged six years and older.
Commenting on the milestone, Dr. Srinivas Arutla, CEO of Zenara Pharma Pvt. Ltd., said:
"Receiving the first generic approval for Sertraline Hydrochloride Capsules highlights Zenara's strong R&D capabilities and operational excellence. We remain committed to our mission of delivering to patients, early access to high-quality, affordable pharmaceuticals."
According to IQVIA™ sales data for the 12-month period ending June 2025, U.S. sales of the reference product totaled approximately $35.5 million.
About Zenara:
Zenara Pharma Private Limited – a Biophore company, is a vertically integrated pharmaceutical company, committed to delivering high-quality pharmaceuticals that are safe, effective, and affordable to patients. Zenara is an industry leader in Research and Development and Manufacturing of Affordable and Quality finished dosage pharmaceutical Products. Zenara is focused on the therapeutic areas of Neurology, Orphan Drugs, Complex Products, Women's health, Cardiology, Imaging, and Contrast Agents among others. For more information, please visit us on the web, or connect with us on our LinkedIn page.
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1 U.S. FDA, Competitive Generic Therapy Approvals
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