Shares of Granules India Ltd fell 1.5% on 8th January after touching a day’s high of Rs 621.80. This occurred despite the company saying its US-based subsidiary received tentative approval from the US drug regulator. The approval came along with 180-day exclusivity for a drug used to treat attention deficit hyperactivity disorder (ADHD).

Granules India said its wholly-owned US subsidiary, Granules Pharmaceuticals Inc., has received tentative approval. The approval is from the US Food and Drug Administration (USFDA) for its abbreviated new drug application for generic Amphetamine Extended-Release Tablets.

The tablets are approved in 5mg, 10mg, 15mg and 20mg strengths. They are the generic equivalent of DYANAVEL XR, used to treat attention deficit hyperactivity disorder (ADHD).

The company said this product has an estimated market size of around $41 million in the US.

Earlier, on 22nd December, Granules received tentative approval for Amphetamine Extended-Release Orally Disintegrating Tablets. These come in strengths ranging from 3.1mg to 18.8mg.

This product is the generic version of ADZENYS XR-ODT, also used for ADHD treatment. Currently, it has only one approved generic and one authorised generic. The addressable market size is $172 million.

Commenting on the development, Chairman and Managing Director Krishna Prasad Chigurupati said the 180-day exclusivity eligibility is a strong support. It aligns well with Granules’ long-term strategy of building a differentiated portfolio of complex generics.

At 11:40 AM, shares of Granules India were trading 0.97% lower at Rs 605 on NSE.

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