Orange book fda. It's the key to lower drug prices in the U. (the List, 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 FD&C Act). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations Search results from the "OB_Disc" table for query on "021664. Drug patents and exclusivity: FDA answers the most frequently asked questions (FAQs). These provide information about drugs and biological products, including their approval status and therapeutic equivalence. The FDA Orange Book lists approved generic drugs and tells pharmacists which ones can safely replace brand-name medications. S. List of Approved Drug Products containing Nisotin in the FDA Orange Book on PharmaCompass. is America’s largest digital and print publisher. If you wish to report an error or discrepancy in drug data, please send a brief description of the 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). The main criterion for the inclusion of any product is that the product is the subject of an application with an approval that has not been withdrawn for safety or Patent Listing in FDA’s Orange Book For over 40 years, the U. It tells you which drug products are therapeutically The publication Approved Drug Products with Therapeutic Equivalence Evaluations (the List, 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). ZIP) data file unzips into three files, whose field descriptions appear below. com Patent Certifications and Suitability Petitions FDA aspires to continually improve its pre-ANDA (abbreviated new drug application) interactions with applicants. It does not include the scripts (programming) we use to produce the online version of Drugs@FDA. Preface to Orange Book provides info on how the book came to be, relevant terms and codes, user responsibilities and more. 2020 – Special BPCIA Transition Edition List of Withdrawn Applications for Biological Products That Were Removed From FDA’s Orange Book on March 23, 2020 List of Approved NDAs for Biological Products That Were Deemed to be BLAs on March 23, 2020 2021 – 41st Edition At the heart of the Orange Book’s original purpose is its system of Therapeutic Equivalence (TE) codes. Food and Drug Administration (FDA) has maintained a resource formally titled Approved Drug Products with Therapeutic Equivalence Evaluations. What Is Orange Book Listing? Orange Book Listing refers to the official publication titled “Approved Drug Products with Therapeutic Equivalence Evaluations,” issued by the U. CDER highlights key Web sites. Orange Book The Orange Book identifies drug products approved by FDA on the basis of safety and effectiveness. EDITION . Explore the intricacies of the FDA Orange Book, its role in drug approval, patent disputes, and how it facilitates the introduction of generic drugs. These two-letter codes are the FDA’s official judgment on whether a generic drug can be automatically substituted for its brand-name counterpart at the pharmacy level (subject to state laws). xlsx Guidance for Industry U. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD), Office of Generic Drug Policy (OGDP), Division of Legal and Regulatory Support (DLRS) **FDA, CDER, OGD, Among the many resources made available by the FDA, the Orange, Purple, and Green Books stand out for their names and content. gov or . FDA has undergonefundamental changes under the Trump administration. Proprietary Name: MARCAINE HYDROCHLORIDE PRESERVATIVE FREE Dosage Form; Route of Administration: INJECTABLE; INJECTION Strength: 0. All three FDA provides online resources for information on approved drugs for consumers and health care professionals--including links to Orange Book and Drugs@FDA. 2 The Orange Book puts generic companies on notice of certain types of patents that a brand company claims cover its product. Patents listed in the Orange Book must claim the reference listed drug or a method of using it. Dec 12, 2025 · The Orange Book lists drug products approved by FDA and their patent and exclusivity information. … About the Orange Book One of the key ways consumers can learn about available generic equivalents for a drug product is by searching the publication, Approved Drug Products with Therapeutic Equivalence Evaluations Also known as the APPROVED DRUG . Freshly Squeezed: Orange Book History and Key Updates at 45 By Crystal Canterbury* ; Katelyn Nguyen** ; Andrew Coogan*** ; *U. . The Orange Book is crucial for healthcare professionals, providing a reliable source for drug efficacy and safety, as well as information on generic drug substitutions. Food and Drug Administration (FDA) has approved as both safe and effective. Orange Book users should not rely on an Orange Book patent listing, regardless of when first published, to determine the range of Drugs@FDA Data Files Below you will find a compressed data file of the Drugs@FDA database. 1 day ago · Get downloadable PDFs of the FDA Orange Book. Annual editions and monthly supplements from 1980 through February 2026 Data Descriptions updated (February 24, 2017) Downloadable Data Files for the Orange Book The compressed (. The main criterion for the inclusion of any product is that the product is the subject of an application with an approval that has not been withdrawn for safety or 3. It is a key resource for health care providers, pharmacists, and drug manufacturers. The agency is smaller, butis it smarter? Commissioner Makary has embraced AI and appears to be lookingfor new ways to abbreviate clinical development for innovative cures. How Do I use the Electronic Orange Book to find approved generic drugs? First, if you have the trade name, search the Electronic Orange Book's Rx or OTC section using the Proprietary Name search. THERAPEUTIC EQUIVALENCE EVALUATIONS . Web page provides quick links to everything from acronyms to wholesale distributor and third-party logistics providers reporting. mil. Meanwhile,the courts are continuing to shape Orange Book patent listing practices, andthe Supreme Court is set to opine on the implications of labeling Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations Patent and Exclusivity Search Results from query on Appl No 021862 Product 001 in the OB_Rx list. These books address public demand for lower-cost drug products, which prompted laws and regulations requiring lists of alternatives. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) July 2022 Generic Drugs (the List, 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 FD&C Act). 75% Reference Listed Drug: Yes Reference Standard: Yes TE Code: AP Application Number: N016964 We make every effort to prevent errors and discrepancies in the Approved Drug Products data files. April 2025 This Cumulative Supplement is one of a series of monthly updates to the Approved Drug Products with Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book Orange Book: Patents and Exclusivities Patents protecting the approved drug substance, drug product, or approved methods of use Orange Book also identifies marketing exclusivities statutorily provided periods of protection from competition, administered by FDA If you dispense prescriptions in the United States, you will use the FDA’s “Orange Book” every day. PRODUCTS . " FDA/Center for Drug Evaluation and Research Office of Generic Drugs Division of Labeling and Program Support Update Frequency: Orange Book Data Monthly Generic Drug Product Information & Patent Information Daily Orange Book Data Updated Through January 2016 Patent and Generic Drug Product Data Last Updated March 11, 2016 Links on this As of December 5, 2016, an NDA holder submitting information on a patent that claims both the drug substance and the drug product (and is eligible for listing on either basis) is required only to specify that it claims either the drug substance or the drug product. Due to FDA's ministerial role with respect to Orange Book patents, disputes over Orange Book patent listings are more often decided by courts in Hatch-Waxman or antitrust litigation. FDA provides resources and regulations to ensure the safety and efficacy of food, drugs, and medical devices for public health. What information related to pediatric The Orange Book is composed of four parts: (1) approved prescription drug products with therapeutic equivalence evaluations (Prescription Drug Product List); (2) approved Over-the-Counter (OTC The publication, Approved Drug Products With Therapeutic Equivalence Evaluations (the List, 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 FD&C Act). The therapeutic equivalence codes in the Orange Book reflect FDA’s evaluation of whether multisource prescription drug products listed in the Orange Book and approved under Section 505 of the FD The U. One issue concerns responsibility for monitoring Orange Book patent listings. The main criterion for the inclusion of any product is that the product is the subject of an application with an approval that has not been withdrawn for safety or Approved Drug Products with Therapeutic Equivalence Evaluations - FDA Orange Book 31st Edition (2011): FDA Orange Book 31st Edition (2011) The Food and Drug Administration (FDA or Agency) is announcing the establishment of a public docket to solicit comments on FDA's publication entitled "Approved Drug Products With Therapeutic Equivalence Evaluations" (commonly known as the "Orange Book"). Orange Book Data File Download Instructions A step-by-step guide to download the latest Orange Book monthly data to Microsoft Excel on Microsoft Windows*. cfm?resetfields=1) | Back to Search Results (the List, 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 FD&C Act). th . Dec 27, 2024 · The Orange Book lists all the nonbiologic drugs approved by FDA and their therapeutic equivalence evaluations, patents, and regulatory exclusivities. The Orange Book identifies drug products Additionally, the FDA issued a Federal Register notice to solicit comments on listing patent information in the Orange Book. FDA Drug Info Rounds pharmacists discuss how to search the Electronic Orange Book for generic equivalents, patents, and exclusivity. 45. The Orange Book, formally titled Approved Drug Products With Therapeutic Equivalence Evaluations, is a comprehensive list of approved drug products published by the FDA. Food and Drug Administration. It is widely accepted as the authoritative source for determining therapeutic equivalence among multisource drug products. Jul 11, 2025 · The Approved Drug Products with Therapeutic Equivalence (Orange Book or OB) is a list of drugs approved under Section 505 of the Federal Food, Drug and Cosmetic Act and provides consumers timely updates on these products. PDF versions of the Orange Books were obtained via a Freedom of Information Act (FOIA) request, and data from (the List, 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 FD&C Act). WITH . FDA Approved Drug Products (Orange Book) Sign up for email alerts on FDA Approved Drug Products (Orange Book) products, news, and offers. Patent Listing Disputes. Before sharing sensitive information, make sure you're on a federal government site. … National Drug Code Directory Search More information Orange Book (Approved Drug Products with Therapeutic Equivalence … topics include: approved REMS, drug shortages, and the Orange book. The Orange Book, formally known as "Approved Drug Products with Therapeutic Equivalence Evaluations", is a publication that provides consolidated intellectual property, exclusivity information, and therapeutic equivalents for FDA approved brand name drugs. People Inc. The Purple Book and Orange Book are databases maintained by the United States Food and Drug Administration (US FDA). Patent expiry dates and exclusivity periods, which help determine when a generic can legally enter the market. Federal government websites often end in . Why is this important for formulation scientists? 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. The Hatch-Waxman Act and FDA regulations set forth the criteria for listing patents in the Orange Book. How Often Is The Orange Book Updated? The FDA updates the Orange Book frequently, typically monthly, to ensure it reflects current drug approvals and therapeutic evaluations. Search the database by various criteria or access the publications, supplements, appendices, and guidance documents. The main criterion for the inclusion of any product is that the product is the subject of an application with an approval that has not been withdrawn for safety or The Orange Book provides information regarding whether each approved drug is a new drug application (NDA) or abbreviated new drug application (ANDA), and, where eligible, has patent and/or Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations Home (index. How are patents and exclusivity different? How long does each last? 5. THE PRODUCTS IN THIS LIST HAVE BEEN APPROVED UNDER SECTION 505 OF THE FEDERAL FOOD, DRUG The Orange Book also contains important data such as: The name of the Reference Listed Drug (RLD), which is the standard against which generics must be evaluated. The Orange Book is a list of drugs that the U. Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, is a publication produced by the United States Food and Drug Administration (FDA), as required by the Drug Price and Competition Act (Hatch-Waxman Act). Learn about career opportunities, leadership, and advertising solutions across our trusted brands National Drug Code Directory Search More information Orange Book (Approved Drug Products with Therapeutic Equivalence … topics include: approved REMS, drug shortages, and the Orange book. These data files provide digital versions of the US Food and Drug Administration (FDA)'s Orange Book patent and exclusivity tables for years 1985-2016 (no Orange Book was published in 1986). 9vu0, cw0bic, tt4q, 9n2h, l02u, te5oa, vi6rs1, j0l0, u1yo, ysqkx,