when a new drug is introduced to the public the food and drug administration fda awards the drugmaker a medical patent that protects the product from competitors for a given period of time orphan drug patents last for seven years while a new chemical entity exclusivity lasts for five years 6
under the hatch waxman act in order for a generic drug manufacturer to win approval they must certify that they will not launch their generic product until after the expiration of the patent 7the orange book is available as a pdf in print and electronically the electronic version of the orange book is the most up to date because there are updates made daily including generic drug approvals and patent information other information may only be updated monthly such as new drug application approvals ad discontinued products 81patent terms are set by statute currently the term of a new patent is 20 years from the date on which the application for the patent was filed in the united states many other factors can affect the duration of a patent 