The hydromorphone hydrochloride tablets are the generic equivalent of Dilaudid 8mg. The brand product and its generic equivalents had annual sales of approximately $28m in 2009 and there are currently four other approved generic manufacturers plus the innovator.
The transfer of the ANDA will begin immediately and Elite expects to begin manufacturing of the product later in the year.
Jerry Treppel, chairman and CEO of Elite, said: “This acquisition continues our strategy of leveraging the manufacturing expertise of the company into products that can generate positive cash flow to support our research activities. We hope to be able to announce other such product acquisitions in the future.”
Elite Pharmaceuticals is a developer of oral sustained and controlled release products. Elite’s strategy includes assisting partner companies in the life cycle management of products to improve off-patent drug products and developing generic versions of controlled release drug products with high barriers to entry.