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: 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	7694676	03/12/2027		DP			06/13/2011
001	7694676*PED	09/12/2027
001	8022082	01/19/2026		DP	U-1186		10/24/2011
001	8022082*PED	07/19/2026
001	9010323	04/19/2030		DP			04/20/2017

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration

 

 

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