What are authorized generics?
An authorized generic is a medicine that was originally marketed and sold as a reference (branded) product, but is relabeled and marketed under a generic product name, usually once patent protection expires. It may be marketed by the brand company itself or through a subsidiary, or the brand company may license the product to another company in return for royalties. Authorized generics are sold at lower cost and as an alternative to the branded product. They do not have to respect the 180-day market exclusivity provision granted by the Hatch Waxman Act to the first generic on the market.