Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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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: N206756

Product 001
OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE (STIOLTO RESPIMAT) SPRAY, METERED EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 7056916 12/07/2023 DS DP
06/10/2015
001 7220742 05/12/2025 DS DP
U-1703 TREATMENT OF RESPIRATORY COMPLAINTS
06/10/2015
001 7284474 08/26/2024 DP
06/10/2015
001 7284474*PED 02/26/2025
001 7396341 10/10/2026 DP
06/10/2015
001 7396341*PED 04/10/2027
001 7491719 11/10/2023 DS DP
06/10/2015
001 7727984 01/19/2027 DS
06/10/2015
001 7786111 11/10/2023 DP
06/10/2015
001 7837235 03/13/2028 DP
06/10/2015
001 7837235*PED 09/13/2028
001 7896264 05/26/2025 DP
06/10/2015
001 8034809 05/12/2025
U-1702 TREATMENT OF COPD
06/10/2015
001 8044046 11/10/2023
U-1702 TREATMENT OF COPD
06/10/2015
001 8733341 10/16/2030 DP
06/10/2015
001 9027967 03/31/2027 DP
06/10/2015

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001
M-233INFORMATION ADDED TO THE LABELING TO DESCRIBE FIXED-DOSE COMBINATION OF TIOTROPIUM BROMIDE AND OLODATEROL TO INCLUDE REDUCTION OF COPD EXACERBATIONS
COMPETITIVE GENERIC THERAPY
10/05/2021

 

 


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