The lawsuit was registered for submission of an abbreviated new drug application (ANDA) to the
US Food and Drug Administration’s (FDA) prior to the expiration of Noven’s patents in 2018 for approval of a generic version of its Daytrana (methylphenidate transdermal system).
Noven is engaged in the research and development of prescription pharmaceutical products.
Noven mainly focuses on three areas including transdermal drug delivery and related manufacturing, the Novogyne joint venture, and Noven Therapeutics, Noven’s specialty pharmaceutical unit.