Granules India Ltd announced that its wholly-owned subsidiary Granules Pharmaceuticals Inc has received US Food and Drug Administration's (USFDA) tentative approval on January 8, 2026 for Amphetamine Extended-Release Tablets used for treating attention deficit hyperactivity disorder (ADHD). The latest approval covers strengths of 5mg, 10mg, 15mg, and 20mg, serving as the generic equivalent of DYANAVEL XR. This marks the second consecutive approval for the company's subsidiary within weeks, following a previous tentative approval received on December 22, 2025 for Amphetamine Extended-Release Orally Disintegrating Tablets in strengths of 3.1mg, 6.3mg, 9.4mg, 12.5mg, 15.7mg, and 18.8mg, the generic equivalent of ADZENYS XR-ODT. Both approvals come with 180-day exclusivity, providing the company with a competitive advantage in the CNS therapeutic space.
The two approved generic formulations target a combined market estimated at $213 million. According to the company's latest announcement, the DYANAVEL XR generic targets an estimated market size of approximately $41 million, while the ADZENYS XR-ODT generic addresses a market of $172 million. The company noted that for the ADZENYS XR-ODT product, only one other approved generic and one authorized generic exist in the market, positioning Granules India favorably with limited competition. Both approvals significantly strengthen the company's presence in the lucrative ADHD treatment segment within the central nervous system therapeutic space.
Krishna Prasad Chigurupati, chairman and managing director of Granules India, emphasized the strategic importance of the approvals. "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," he stated. The 180-day exclusivity periods for both products are expected to strengthen Granules India's positioning in the US generics market, providing critical windows to capture additional market share upon launch. The company's focus on complex formulations in the CNS therapeutic space aligns with broader trends favoring differentiated product portfolios that reduce direct competition and optimize margins.
Despite the positive regulatory developments, Granules India shares declined 1.5% to ₹605 during trading on Thursday, January 8, reflecting a negative investor response to the strategic wins. The stock had touched a day's high of ₹621.80 before declining, showing initial optimism that faded during the session. At 11:40 AM, shares were trading 0.97% lower at ₹605 on NSE, indicating continued weakness despite the regulatory milestone. The negative market reaction suggests investors may be awaiting actual product launches and revenue generation from the exclusivity periods before responding more positively to these strategic approvals, with the stock remaining broadly flat over the past twelve months despite recent regulatory successes.
