Tentative FDA nod, exclusivity for generic Dyanavel XR

Indian drugmaker Granules India (BSE: 532482) has announced its US subsidiary has secured tentative approval from the US Food and Drug Administration (FDA)for amphetamine extended-release tablets, with eligibility for 180-day exclusivity. The product is a generic version of Dyanavel XR (amphetamine) for attention deficit hyperactivity disorder.

The filing covers 5 mg, 10 mg, 15 mg and 20 mg strengths. Granules said the branded reference product has an estimated US market size of about $41 million. Commercial launch will depend on the clearance of remaining regulatory and patent-related barriers.

The tentative nod follows a similar decision late last month for generic Adzenys XR-ODT (amphetamine), marking back-to-back approvals for Granules Pharmaceuticals within weeks. That earlier product targets an addressable US market of about $172 million, with limited existing generic competition.