Hyderabad-Based Pharmaceutical Gets US Nod For Generic ADHD Drug: Why This Matters And What It Means

Hyderabad-based Granules Pharmaceuticals has received tentative approval from the US Food and Drug Administration (FDA) for its generic Attention Deficit Hyperactivity Disorder (ADHD) medication.

The approval relates to Amphetamine Extended-Release Tablets, the generic version of the branded drug Dyanavel XR, which is prescribed for people with ADHD. The approval covers tablet strengths of 5 mg, 10 mg, 15 mg and 20 mg and targets an estimated market of about USD 41 million in the United States.

US drug regulators have also ruled that the company's Abbreviated New Drug Application qualifies for a 180-day exclusivity period, allowing Granules limited competition during the initial phase of commercialisation once final clearance is granted.

What is ADHD?

ADHD is a neurodevelopmental condition that affects both children and adults. It is characterised by symptoms such as difficulty concentrating, impulsive behaviour and hyperactivity. These symptoms can affect academic performance, work productivity and social relationships.

Doctors say ADHD is linked to differences in brain development and is not caused by poor discipline or parenting. While it is commonly diagnosed in childhood, many people continue to experience symptoms into adulthood.

How is ADHD generally treated?

Treatment for ADHD usually involves behavioural therapy, medication, or a combination of both. Medications commonly prescribed include stimulant drugs such as amphetamines, which help improve attention span and reduce impulsivity by increasing certain brain chemicals.

Extended-release formulations are widely used because they release the drug slowly over the day, allowing patients to manage symptoms with a single dose. This is especially helpful for school-going children and working adults who need sustained symptom control.

Why does this drug approval matter?

Branded ADHD medications in the US can be costly, making long-term treatment difficult for many families. The approval of a generic version is expected to improve affordability and access to treatment.

The 180-day exclusivity granted by the FDA means Granules will face limited competition during the initial launch period, encouraging faster market entry while still expanding treatment options for patients.

Granules had also received tentative approval in December 2025 for another generic ADHD drug, Adzenys XR-ODT, indicating a broader push to expand access to complex ADHD therapies.

What does this mean for people with ADHD?

For people, the key benefit is access to a lower-cost alternative that meets the same safety, quality and effectiveness standards as the branded drug. For healthcare providers and insurers, greater availability of generics can help reduce overall prescription drug spending.

Extended-release generic options also provide flexibility for doctors to tailor treatment based on patient needs and tolerance.

Is there anything to worry about?

Medical experts caution that stimulant medications must be used strictly under medical supervision. Side effects can include sleep problems, reduced appetite and increased heart rate, and misuse can lead to dependency.

However, these concerns apply equally to branded and generic drugs. FDA approval ensures that generic medicines are held to the same regulatory standards as their branded counterparts.

The regulator's tentative approval of Granules' generic ADHD drug is expected to improve access, affordability and choice for patients, while highlighting India's growing role in supplying complex generic medicines to global markets.

This development follows closely on another regulatory win for the company. In December, Granules received tentative approval for Amphetamine Extended-Release Orally Disintegrating Tablets, a generic alternative to Adzenys XR-ODT, also used in ADHD treatment.

That earlier-approved product operates in a significantly larger market, with an addressable opportunity of nearly 172 million dollars, and currently faces minimal generic competition, according to the company.

Disclaimer: This content including advice provides generic information only. It is in no way a substitute for a qualified medical opinion. Always consult a specialist or your own doctor for more information. NDTV does not claim responsibility for this information.