Granules Pharmaceuticals Receives Tentative FDA Approval for Generic ADHD Treatment
Key Insights
Granules Pharmaceuticals (search) received tentative FDA approval for its generic amphetamine extended-release orally disintegrating tablets (search) in six dosage strengths for ADHD (search) treatment.
The product is a generic equivalent of ADZENYS XR-ODT with an estimated market size of approximately $172 million according to IQVIA.
Currently only one approved generic and one authorized generic exist in the market, positioning Granules favorably to expand access upon launch.
Granules Pharmaceuticals (search), a wholly owned subsidiary of Granules India, has received tentative approval from the U.S. Food and Drug Administration (search) for its Abbreviated New Drug Application for amphetamine extended-release orally disintegrating tablets (search). The approval covers six dosage strengths of 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, and 18.8 mg, representing the generic equivalent of ADZENYS XR-ODT for treating Attention Deficit Hyperactivity Disorder (search).
Market Positioning and Commercial Opportunity
The product addresses a significant market opportunity with an estimated market size of approximately $172 million according to IQVIA (IMS Health). Currently, the market has only one approved generic and one authorized generic, positioning Granules favorably to expand access to this critical therapy upon launch.
The tentative approval signifies that the product meets all required standards set by the FDA, although final approval remains pending patent or exclusivity expiration. This regulatory milestone represents a strategic advancement for Granules in the central nervous system therapeutic area.
Manufacturing and Strategic Focus
Manufacturing of the amphetamine ER ODT will take place at Granules' US-based facility located in Chantilly, Virginia. The extended-release formulation is designed as an orally disintegrating tablet, offering an alternative method of administration for ADHD (search) patients.
"The tentative approval of this ANDA reaffirms Granules' strategic focus on expanding its portfolio of complex and differentiated generics while strengthening its presence in the central nervous system therapeutic area," stated Dr. Krishna Prasad Chigurupati, Chairman and Managing Director. "ADHD (search) is one of the most commonly diagnosed neurodevelopmental disorders in the United States and impacts hundreds of millions of people worldwide."
Company Background and Global Reach
Granules India Limited, incorporated in 1991, operates as a vertically integrated pharmaceutical company headquartered in Hyderabad. The company maintains a presence across the entire pharmaceutical value chain, from Active Pharmaceutical Ingredients and Pharmaceutical Formulation Intermediates to Finished Dosages and Peptides CDMO.
The company's products reach over 300 customers in regulated and semi-regulated markets, with global presence extending to over 80 countries through offices across India, the US, and Switzerland. Granules operates 11 manufacturing facilities, including 8 in India, 2 in the USA, and 1 in Switzerland, with regulatory approvals from multiple international agencies including US FDA, EDQM, EU GMP, and WHO GMP.
Dr. Chigurupati emphasized the company's commitment to improving patient access, stating, "At Granules, we remain committed to improving patient access by delivering high-quality, affordable medications across global markets." This approval further strengthens Granules' US generics portfolio as the company continues expanding its therapeutic offerings.