Granules India Secures USFDA Tentative Approval for Generic ADHD Tablets; Eligible for 180-Day Exclusivity
By Axel Miller | 08 Jan 2026
Granules India on Thursday, January 8, 2026, announced that its wholly owned US subsidiary, Granules Pharmaceuticals Inc. (GPI), has received tentative approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Amphetamine Extended-Release (ER) Tablets.
The US regulator has further determined that the ANDA is eligible for 180 days of marketing exclusivity. While this exclusivity remains subject to final approval and the resolution of listed patent matters, it represents a potentially high-value entry opportunity for the Hyderabad-based pharmaceutical major in the US ADHD market.
The “Complex CNS” Portfolio Build
The approved Amphetamine ER tablets, in strengths of 5 mg, 10 mg, 15 mg, and 20 mg, address the same ADHD therapeutic category as branded amphetamine extended-release products such as Dyanavel XR, an extended-release oral suspension marketed by Tris Pharma. Granules’ ANDA represents a tablet-based alternative within the amphetamine ER segment, rather than a like-for-like dosage-form generic.
This marks Granules’ second major regulatory milestone in the CNS space within three weeks. On December 22, 2025, the company received tentative approval for a generic version of Adzenys XR-ODT (orally disintegrating tablets). By focusing on complex CNS delivery formats—extended-release tablets and ODTs—Granules is targeting market segments with structurally higher barriers to entry and lower competitive intensity than conventional oral suspensions.
Market Dynamics: $213 Million Addressable Opportunity
According to IQVIA (IMS Health) MAT data, the combined addressable market for Granules’ two recently approved ADHD products is estimated at over $213 million.
Granules India: Recent ADHD Regulatory Milestones
| Product | Therapeutic Reference | Dosage Form | Market Size (Est.) | Regulatory Status |
|---|---|---|---|---|
| Amphetamine Extended-Release Tablets | Amphetamine ER category (competes with branded ER amphetamine therapies such as Dyanavel XR*) | Extended-Release Tablet | ~$41 million | Tentative Approval (Jan 8, 2026)Eligible for 180-day exclusivity |
| Amphetamine Extended-Release ODT | Adzenys XR-ODT (Tris Pharma) | Orally Disintegrating Tablet (ODT) | ~$172 million | Tentative Approval (Dec 22, 2025) |
* Dyanavel XR is marketed as an extended-release oral suspension. Granules’ approval represents a tablet-based alternative within the same therapeutic category.
“Having a product eligible for 180-day exclusivity validates our long-term strategy of building a differentiated portfolio of complex generics,” said Dr. Krishna Prasad Chigurupati, Chairman and Managing Director of Granules India.
The company confirmed that commercial manufacturing for both products will be centralized at its US facility in Chantilly, Virginia, strengthening supply-chain security and alignment with domestic US sourcing preferences.
Summary
Granules India has achieved a double regulatory win in the ADHD therapeutic space, securing tentative USFDA approval and exclusivity eligibility for its amphetamine extended-release tablet ANDA, following a larger ODT approval in late 2025. While commercial launches remain contingent on patent outcomes, the company’s focus on complex CNS formulations and US-based manufacturing positions it for meaningful revenue traction from FY27 onward.
Frequently Asked Questions (FAQs)
Q1: Is 180-day exclusivity guaranteed?
No. Exclusivity represents eligibility for first-to-file applicants and is granted only upon final approval and commercial launch, subject to patent resolution.
Q2: Is this a generic of the Dyanavel XR liquid?
No. Dyanavel XR is marketed only as an extended-release oral suspension. Granules’ approval is for an amphetamine extended-release tablet that competes within the same therapeutic category, but is not a dosage-form equivalent.
Q3: Why did the stock react modestly to the news?
Market participants noted that tentative approvals do not translate into immediate revenue. With commercialization expected in FY27 and a fundraising EGM scheduled for January 22, some investors remain cautious in the near term.
Q4: When could these products launch?
Based on patent tracking and industry estimates, potential launch windows are expected between late 2026 and early 2027, subject to legal and regulatory outcomes.
