8 months ago
Hyderabad Firm Gets US Nod for Generic ADHD Drug
A company in Hyderabad, India, called Granules Pharmaceuticals, has gotten permission from the US government to sell a cheaper version of a medicine used to treat ADHD.
This medicine, called Amphetamine Extended-Release Tablets, is a copy of a more expensive drug called Dyanavel XR.
The US government has also said that Granules can be the only company selling this medicine for 180 days, which means they won't have competition for a while.
This is good news because it might make the medicine cheaper and easier to get for people who need it.
The company has also gotten permission to sell another ADHD medicine in the US.
Doctors use these medicines to help people with ADHD focus better and control their behavior.
But it's important to use these medicines carefully, as they can have side effects and should only be taken under a doctor's supervision.
Granules Pharmaceuticals received US FDA tentative approval for generic ADHD drug Amphetamine Extended-Release Tablets.
The drug is a generic version of the branded medication Dyanavel XR, available in 5 mg, 10 mg, 15 mg, and 20 mg strengths.
The approval covers an estimated USD 41 million market in the US and includes a 180-day exclusivity period.
The company previously received tentative approval for another generic ADHD drug, Adzenys XR-ODT, in December 2025.
The approval aims to improve affordability and access to ADHD treatment, with the generic drug meeting the same safety and quality standards as the branded version.
- Who
- Granules Pharmaceuticals, a Hyderabad-based company
- What
- Received tentative US FDA approval for generic ADHD drug
- Where
- United States
- When
- Not specified
- Why
- To improve affordability and access to ADHD treatment
Key facts
- Company
- Granules Pharmaceuticals
- Drug
- Amphetamine Extended-Release Tablets
- Branded Drug
- Dyanavel XR
- Market Size
- USD 41 million
- Exclusivity Period
- 180 days
- Tablet Strengths
- 5 mg, 10 mg, 15 mg, 20 mg
- Previous Approval
- Adzenys XR-ODT (December 2025)
- Previous Market Size
- USD 172 million
