'Not only can there be multiple orphan designations per indication; more than one sponsor can receive an orphan designation for the same drug/indication. However, only the first drug to be approved for a given indication will enjoy the benefits of orphan approval. A product with a different active moiety can also receive orphan approval for an already approved orphan indication. Additionally, a second sponsor may gain orphan approval for a previously approved orphan drug/indication if the second sponsor’s product demonstrates increased clinical benefit, e.g. oral administration instead of intravenous.'


http://www.pharmaceuticalcommerce.com/index.p...leid=27143