Shares of Granules India Ltd. gave up early gains on Thursday, January 8, despite its US-based subsidiary receiving tentative approval from the US drug regulator with 180-day exclusivity for a drug that treats attention deficit hyperactivity disorder (ADHD).

FDA Approval Details

The company's wholly-owned subsidiary Granules Pharmaceuticals Inc. has received the US Food and Drug Administration's tentative approval for its abbreviated new drug application for generic Amphetamine Extended-Release Tablets. The approval covers multiple strengths including 5mg, 10mg, 15mg and 20mg formulations, serving as the generic equivalent of DYANAVEL XR.

Additional ADHD Portfolio Expansion

Granules announced on December 22 that it had received tentative approval for Amphetamine Extended-Release Orally Disintegrating Tablets in six different strengths: 3.1mg, 6.3mg, 9.4mg, 12.5mg, 15.7mg and 18.8mg. This drug serves as the generic equivalent of ADZENYS XR-ODT, also for ADHD treatment.

Strategic Market Position

"Having a product that is eligible for 180-day exclusivity, Granules strongly validates our long-term strategy of building a differentiated portfolio of complex generics," said Krishna Prasad Chigurupati, the chairman and managing director of Granules India.

The 180-day exclusivity period provides Granules with a significant competitive advantage, allowing the company to be among the first to market these generic ADHD treatments before other competitors can enter.

Stock Performance

Shares of Granules India are currently trading little changed on Thursday at ₹611.90. The stock has remained flat over the last 12 months, showing minimal movement despite the regulatory achievements in the ADHD treatment segment.

Granules India Limited announced that its wholly owned subsidiary Granules Pharmaceuticals Inc. has received tentative approval from the U.S. Food and Drug Administration (FDA) for its second generic ADHD medication within weeks. The latest approval, announced on January 8, 2026, covers generic Amphetamine Extended-Release Tablets with 180-day exclusivity, marking a significant milestone in the company's central nervous system therapeutic expansion.

Latest FDA Approval with Market Exclusivity

The recent tentative approval covers generic Amphetamine Extended-Release Tablets in four strengths, positioning it as the generic equivalent of DYANAVEL XR. The FDA has determined that Granules' ANDA is eligible for 180-day exclusivity, providing the company with a competitive advantage in this specialized market segment.

Previous ADHD Drug Approval

Granules previously received tentative approval on December 22, 2025, for Amphetamine Extended-Release Orally Disintegrating Tablets, the generic equivalent of ADZENYS XR-ODT. This earlier approval covers six different strengths and targets a significantly larger market opportunity.

Strategic Market Positioning

Both products are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), positioning Granules to serve different segments of this therapeutic market. The combined market opportunity of approximately USD 213.00 million demonstrates the company's strategic focus on high-value, complex generic formulations with limited competition.

Management Commentary and Strategic Vision

Dr. Krishna Prasad Chigurupati, Chairman and Managing Director, emphasized that having a product eligible for 180-day exclusivity strongly validates Granules' long-term strategy of building a differentiated portfolio of complex generics. He highlighted that this achievement reinforces the company's commitment to strengthening its presence in the central nervous system therapeutic space while enhancing value creation in the U.S. generics market.

The consecutive approvals within weeks demonstrate Granules' expanding capabilities in complex formulation development and regulatory execution, reinforcing the company's ability to identify, develop, and progress technically challenging products that deliver meaningful differentiation and long-term value in the U.S. generics market.