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: N209478

Product 001
SPIRONOLACTONE (CAROSPIR) SUSPENSION 25MG/5ML

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
001	9757394	10/28/2036		DP	U-2109		09/21/2017
001	10493083	10/28/2036		DP			01/02/2020
001	10624906	10/28/2036		DP			04/27/2020
001	10660907	10/28/2036		DP			06/15/2020
001	10888570	10/28/2036		DP			01/15/2021
001	11389461	10/28/2036		DP			07/22/2022
001	11395828	10/28/2036			U-2109 U-3401 U-3402		08/02/2022
001	11491166	10/28/2036		DP			11/18/2022

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration

 

 

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