_dta: 1. by Jean Roth , jroth@nber.org , 12 Oct 2018 2. NBER URL: http://www.nber.org/data/fda-orange-book-data.html 3. Source Page: http://www.fda.gov/Drugs/InformationOnDrugs/ucm129662.htm 4. Source File URL: www.fda.gov/downloads/Drugs/InformationOnDrugs/UCM163762.zip 5. Source Text File: patent.txt appl_type: 1. New Drug Application Type. The type of new drug application approval. 2. New Drug Applications (NDA or innovator) are "N". Abbreviated New Drug Applications (ANDA or generic) are "A". appl_no: 1. New Drug Application (NDA) Number The FDA assigned number to the application. Format is nnnnnn. product_no: 1. Product Number. The FDA assigned number to identify the application products. 2. Each strength is a separate product. May repeat for multiple part products. Format is nnn. patent_no: 1. Patent Number. Patent numbers as submitted by the applicant holder for patents covered by the statutory provisions. 2. May repeat for multiple applications and multiple products. Includes pediatric exclusivity granted by the agency. 3. Format is nnnnnnnnnnn. patexp: 1. Patent Expire Date. The date the patent expires as submitted by the applicant holder including applicable extensions. 2. The format is MMM DD, YYYY. drugsub: 1. Drug Substance Flag. Patents submitted on FDA Form 3542 and listed after August 18, 2003 may have a drug substance flag 2. indicating the sponsor submitted the patent as claiming the drug substance. Format is Y or null. drugprod: 1. Drug Product Flag. Patents submitted on FDA Form 3542 and listed after August 18, 2003 may have a drug product flag 2. indicating the sponsor submitted the patent as claiming the drug product. Format is Y or null. patuse: 1. Patent Use Code. Code to designate a use patent that covers the approved indication or use of a drug product. 2. May repeat for multiple applications, multiple products and multiple patents. Format is nnnnnnnnnn. delist: 1. Patent Delist Request Flag. Sponsor has requested patent be delisted. This patent has remained listed because, 2. under Section 505(j)(5)(D)(i) of the Act, a first applicant may retain eligibility for 180-day exclusivity 3. based on a paragraph IV certification to this patent for a certain period. 4. Applicants under Section 505(b)(2) are not required to certify to patents where this flag is set to Y. 5. Format is Y or null. obs: 14,174 vars: 11 12 Oct 2018 12:32 size: 779,570 (_dta has notes) ------------------------------------------------------------------------------------------------------------------------------------------- storage display value variable name type format label variable label ------------------------------------------------------------------------------------------------------------------------------------------- appl_type str1 %9s * Application Type appl_no long %12.0g * Application Number product_no byte %8.0g * Product Number patent_no str11 %11s * Patent Number patexpstr str12 %12s Patent Expire Date Text String patexp float %td * Patent Expire Date drugsub str1 %9s * Drug Substance Flag drugprod str1 %9s * Drug Product Flag patuse str7 %9s * Patent Use Code delist str1 %9s * Delist Flag submission_date str12 %12s Submission_Date * indicated variables have notes ------------------------------------------------------------------------------------------------------------------------------------------- Sorted by: product_no patent_no appl_no patuse