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: N022202

Product 001
DICLOFENAC POTASSIUM (ZIPSOR) CAPSULE 25MG

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
001	7662858	02/24/2029			U-1035
001	7884095	02/24/2029			U-1111		02/22/2011
001	7939518	02/24/2029			U-980		05/19/2011
001	8110606	02/24/2029			U-980		02/13/2012
001	8623920	02/24/2029			U-1482		02/05/2014
001	9561200	02/24/2029			U-1482		02/14/2017

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration
001	NPP	05/25/2024

 

 

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