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: N208694

Product 001
CETIRIZINE HYDROCHLORIDE (ZERVIATE) SOLUTION/DROPS EQ 0.24% BASE

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
001	8829005	03/15/2030			U-1680		06/23/2017
001	8829005*PED	09/15/2030
001	9254286	07/09/2032		DP			06/23/2017
001	9254286*PED	01/09/2033
001	9750684	03/15/2030		DP			09/14/2017
001	9993471	03/15/2030			U-1680		07/03/2018

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration

 

 

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