Jubilant Life Sciences Ltd, an integrated Pharma and Life Sciences Company and the largest Custom Research & Manufacturing player out of India has received approval from the US Food and Drug Administration (US FDA) for Donepezil Hydrochloride tablets 5 mg and 10 mg, a generic equivalent of Aricept.
Donepezil Hydrochloride tablets are indicated for the treatment of dementia of the Alzheimer’s type, in patients with mild, moderate and severe Alzheimer’s disease. The total annual market sales for Aricept 5 mg and 10 mg tablets were $2.6 billion, according to IMS-MAT: September 2010.
Commenting on the approval, Shyam S Bhartia, chairman & managing director and Hari S Bhartia, co-chairman & managing director, Jubilant Life Sciences said, “the launch of Donepezil, will now expand our generic product portfolio in USA. This will be our first product from the Indian dosage form facility set up in Roorkee, Uttarakhand, for the US market and paves the way for further approvals from this facility.”
Donepezil Hydrochloride Tablets will be manufactured at Jubilant Life Sciences state of the art dosage form facility at Roorkee in India, with backward integration into the API manufactured at the company’s US FDA approved API facility at Nanjangud in India. The product will be marketed by its US subsidiary Jubilant Cadista Pharmaceuticals Inc. under its label. With this approval Jubilant Cadista will have 15 commercialized products in the US market.
Jubilant along with its subsidiary Cadista, currently holds 17 ANDA approvals and has a pipeline of 19 ANDAs awaiting approvals from the US FDA.
Jubilant’s generic formulation of Aricept will benefit the US healthcare system by providing a more affordable treatment option to patients, which will have a positive impact on escalating US healthcare costs. According to the Alzheimer’s Association, 5.3 million Americans of all ages have Alzheimer’s disease. Aricept is a registered trademark of Eisai Inc.