US-based Elite Pharmaceuticals has announced the acquisition of an approved abbreviated new drug application (ANDA) for naltrexone hydrochloride from Mikah Pharma.
The product and its generics equivalents had annual sales totalling $14m in 2009, and there are currently three other approved generic manufacturers. Elite expects to begin manufacturing the drug early next year, with the ANDA transfer starting immediately.
As part of the agreement, Elite will sell the drug in the US and its territories, with Mikah licensed to sell the drug in the remainder of the world.
Elite and Mikah have also entered an agreement to develop a product, with Elite responsible for the formulation, clinical batch manufacture and validation work before seeking approval. Mikah will then be responsible for the manufacture and supply of the product, following an agreement between the two parties.
