Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Product Details

Additional Information about Patents

  • Patent information is published on or after the submission date as defined in 21 CFR 314.53(d)(5).
  • Patent listings published prior to August 18, 2003, only identify method-of-use claims. The listed patents may include drug substance and/or drug product claims that are not indicated in the listing.
  • 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. Orange Book users should not rely on an Orange Book patent listing, regardless of when first published, to determine the range of patent claims that may be asserted by an NDA holder or patent owner.

Patent and Exclusivity for: N021395

Product 001
TIOTROPIUM BROMIDE (SPIRIVA) POWDER EQ 0.018MG BASE/INH

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 6777423 09/24/2021 DS DP
001 6777423*PED 03/24/2022
001 6908928 09/24/2021 DS DP
U-566 FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF BRONCHOSPASM ASSOCIATED WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND EMPHYSEMA
U-762 TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
001 6908928*PED 03/24/2022
001 7070800 01/22/2022 DP
U-566 FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF BRONCHOSPASM ASSOCIATED WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND EMPHYSEMA
001 7070800*PED 07/22/2022
001 7309707 09/24/2021 DS DP
001 7309707*PED 03/24/2022
001 7642268 09/24/2021 DS DP
001 7642268*PED 03/24/2022
001 7694676 03/12/2027 DP
06/13/2011
001 7694676*PED 09/12/2027
001 8022082 01/19/2026 DP
U-1186 ADMINISTRATION OF AN INHALABLE POWDER COMPRISING TIOTROPIUM VIA DEVICE
10/24/2011
001 8022082*PED 07/19/2026
001 9010323 04/19/2030 DP
04/20/2017
001 RE38912 10/11/2021 DP
001 RE38912*PED 04/11/2022
001 RE39820 01/30/2018 DS DP
U-566 FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF BRONCHOSPASM ASSOCIATED WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND EMPHYSEMA
001 RE39820*PED 07/30/2018

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
There is no unexpired exclusivity for this product in the Orange Book database.

View a list of all patent use codes
View a list of all exclusivity codes

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English