Purple Book Licenced Biological Products

**Overview**
This data package consists of a comprehensive list of FDA (Food and Drug Administration) approved drug products according to therapeutic equivalence exclusivity, patent and Products. It also provides detailed list of CBER (Center for Biologics Evaluation Research) and CDER (Center for Drug Evaluation Research) licensed biological products.

**Description**
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). Exclusivity dataset contains application type, exclusivity code, exclusivity date etc. for approved drug products with therapeutic equivalence. The patent dataset contains drug ingredient, dosage form, route, product number, therapeutic equivalence code, whether or not it is reference listed drug etc. The therapeutic equivalence products dataset contains drug ingredient, dosage form, route, trade name, strength, product number, therapeutic equivalence code etc. for approved drug products with therapeutic equivalence. The Purple Book is the biological equivalent of the pharmaceutical Orange Book, and seeks to aid regulatory agents, generic manufacturers, and physicians by arming them with information related to biological products such as biosimilars including, for example, providing information regarding the interchangeability of products. CBER dataset contains a list of biological products regulated by the Center for Biologics Evaluation and Research (CBER). CDER dataset contains a list of biological products regulated by the Center for Drug Evaluation and Research (CDER).

**Benefits**
- available in clean well curated dataset making it easier for medical professionals to search for generic equivalents to brand-name drugs, drug patents and drug exclusivity.
- patients and doctors can see approved uses for drugs and patent expiration dates for name-brand drugs. for example, a search for the prescription antidepressant drug prozac shows that the drug is available in four dosage forms of varying strengths, all of which are capsules taken orally.
- at par with electronic versions of the orange book, as its updated monthly.

**License Information**
The use of John Snow Labs datasets is free for personal and research purposes. For commercial use please subscribe to the [Data Library](https://www.johnsnowlabs.com/marketplace/) on John Snow Labs website. The subscription will allow you to use all John Snow Labs datasets and data packages for commercial purposes.

**Included Datasets**
- [Approved Drug Products with Therapeutic Equivalence Exclusivity](https://www.johnsnowlabs.com/marketplace/approved-drug-products-with-therapeutic-equivalence-exclusivity)
- This dataset is also called Orange Book. The dataset contains application type, exclusivity code, exclusivity date etc for approved drug products with therapeutic equivalence.
- [Approved Drug Products with Therapeutic Equivalence Patent](https://www.johnsnowlabs.com/marketplace/approved-drug-products-with-therapeutic-equivalence-patent)
- This dataset is also called Orange Book. The dataset contains drug ingredient, dosage form, route, product number, therapeutic equivalence code, whether or not it is reference listed drug etc.
- [Approved Drug Products with Therapeutic Equivalence Products](https://www.johnsnowlabs.com/marketplace/approved-drug-products-with-therapeutic-equivalence-products)
- This dataset is also called Orange Book. The dataset contains drug ingredient, dosage form, route, trade name, strength, product number, therapeutic equivalence code etc. for approved drug products with therapeutic equivalence.
- [Center for Biologics Evaluation Research Licensed Biological Products](https://www.johnsnowlabs.com/marketplace/center-for-biologics-evaluation-research-licensed-biological-products)
- This dataset contains a list of biological products regulated by the Center for Biologics Evaluation and Research (CBER). The Purple Book is the biological equivalent of the pharmaceutical Orange Book, and seeks to aid regulatory agents, generic manufacturers, and physicians by arming them with information related to biological products such as biosimilars including, for example, providing information regarding the interchangeability of products.
- [Center for Drug Evaluation Research Licensed Biological Products](https://www.johnsnowlabs.com/marketplace/center-for-drug-evaluation-research-licensed-biological-products)
- This dataset contains a list of biological products regulated by the Center for Drug Evaluation and Research (CDER). The Purple Book is the biological equivalent of the pharmaceutical Orange Book, and seeks to aid regulatory agents, generic manufacturers, and physicians by arming them with information related to biological products such as biosimilars including, for example, providing information regarding the interchangeability of products.

**Data Engineering Overview**
**We deliver high-quality data**
- Each dataset goes through 3 levels of quality review
- 2 Manual reviews are done by domain experts
- Then, an automated set of 60+ validations enforces every datum matches metadata & defined constraints
- Data is normalized into one unified type system
- All dates, unites, codes, currencies look the same
- All null values are normalized to the same value
- All dataset and field names are SQL and Hive compliant
- Data and Metadata
- Data is available in both CSV and Apache Parquet format, optimized for high read performance on distributed Hadoop, Spark & MPP clusters
- Metadata is provided in the open Frictionless Data standard, and its every field is normalized & validated
- Data Updates
- Data updates support replace-on-update: outdated foreign keys are deprecated, not deleted

**Our data is curated and enriched by domain experts**

Each dataset is manually curated by our team of doctors, pharmacists, public health & medical billing experts:
- Field names, descriptions, and normalized values are chosen by people who actually understand their meaning
- Healthcare & life science experts add categories, search keywords, descriptions and more to each dataset
- Both manual and automated data enrichment supported for clinical codes, providers, drugs, and geo-locations
- The data is always kept up to date – even when the source requires manual effort to get updates
- Support for data subscribers is provided directly by the domain experts who curated the data sets
- Every data source’s license is manually verified to allow for royalty-free commercial use and redistribution.

**Need Help?**
If you have questions about our products, contact us at [[e-mail]](mailto:[e-mail]).

搜集汇总

背景与挑战

背景概述

该数据集汇总了FDA批准的药品治疗等效性、专利和独占性信息，以及CBER和CDER监管的生物制品列表。它旨在为医疗专业人员、监管机构和制造商提供关于药品和生物制品（如生物类似药）的详细数据，以支持搜索、决策和产品互换性评估。