Fda orange book use codes

Refer to the eob home page preface for discussion and definitions of the te code and reference listed drug rld. How do i use the electronic orange book to find approved generic drugs. The electronic availability of the orange book brings this valuable tool to the web for healthcare. Cfr code of federal regulations title 21 food and drug. And, oh, by the way, the new regulations will result in other new orange book firsts as fda is required to make several changes to the orange book, including identifying patents for which a dispute has been submitted by an interested party. The nda holder must confirm the correctness of its description of the approved method of use claimed by the patent that has been included as the use code in the orange book, or withdraw or amend the patent information in accordance with paragraph f2 of this section, provide a narrative description no more than 250 words of the nda holders interpretation of the scope of the patent that explains why the existing or amended use code describes only the specific approved method of use. May repeat for multiple applications, multiple products and multiple patents. Codes beginning with a signify the product is deemed therapeutically equivalent to the reference product for the category. Finally, the orange book lists patents that are purported to protect each drug. Food and drug administration fda has approved as both safe and effective.

A major focus of the rule, which goes into effect on december 5, 2016, is patent use codes. Codes beginning with b indicate bioequivalence has not been confirmed. Patent use code code to designate a use patent that covers the approved indication or use of a drug product. The orange book has long been a reliable resource for information about fda approved drugs. 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. Orange book codes the orange book codes supply the fda s therapeutic equivalence rating for applicable multisource categories. Fdas proposed rules to address inaccurate orange book.