The publication approved drug products with therapeutic equivalence evaluations commonly known as the orange book identifies drug products approved on the basis of safety and effectiveness by the food and drug administration fda under the federal food, drug, and cosmetic act the act and related patent and exclusivity information. Reference standard rs a reference standard is the drug product selected by fda that an applicant seeking approval of an anda must use in conducting an in vivo bioequivalence study required for approval of an anda. Fda introduces patent submission date updates to the orange book. These were crossreferenced with the food and drug administrations orange book, which lists approved pharmaceutical drugs patents, patent expiration dates and. If the nda holder is submitting information on a patent that claims an approved drug or an approved method of using the drug after approval of an nda or supplement, use form fda 3542. In the electronic orange book, an rld is identified by rld in the rld column. I want drug information not found in the orange book. Purpose and history of fdas orange book brief overview. Food and drug administrations orange book has been a bedrock of pharmaceutical patent disputes in the decades since it was first published. Patents submitted on fda form 3542 and listed after august 18, 2003 may have a drug product flag indicating the sponsor submitted the patent. Ndas must be accompanied by certain patent information, which the fda then lists in its approved drug products with therapeutic equivalence evaluations publication known as the orange book.
Food and drug administration fda introduced an important data update to approved drug products with. The agency will not list or publish patent information in the orange book if it is not provided on form fda 3542. A new breed of antitrust challenges to fdas orange book. Ascii text files of the orange book drug product, patent, and exclusivity data at. The orange book has long been a reliable resource for information about fdaapproved drugs. Having patent information listed in the fda s orange book provides benefits of possible regulatory stays under the hatchwaxman act, which protect nda holders from harm that could otherwise result from fda approval of an infringing drug product.
The fda s publication approved drug products with therapeutic equivalence evaluations, commonly referred to as the orange book, includes information about patents or exclusivities that. The list is cumulative in nature and is organized by drug product established name and patent numbers. Orange book cumulative supplement 03 march 2020 fda. Electronic orange book fda food and drug administration. There are ascii text files of the orange book drug product, patent, and exclusivity data. Exclusivity is a statutory provision and is granted to an nda. Requirements, benefits, and possible consequences of.
The patent listing dispute list contains relevant drug product information and the disputed patent. Food and drug administration fda introduced an important data update to approved drug products. Key content and format of the obs drug product lists. Food and drug administration fda has approved as both safe and effective. Approved drug products with therapeutic equivalence evaluations. Fda drug info rounds pharmacists discuss how to search the electronic orange book for generic equivalents, patents, and exclusivity. Exclusivity is exclusive marketing rights granted by the fda upon approval of a drug and can run concurrently with a patent or not. The orange book provides information on patents for drugs that the fda has approved for public use, which makes it much easier for generic drug companies to identify whether or not the drug they wish to manufacture is already patented and fdaapproved.