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: N022306

Product 001
SOTALOL HYDROCHLORIDE (SOTALOL HYDROCHLORIDE) SOLUTION 150MG/10ML (15MG/ML)

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
001	10512620	08/14/2038			U-2769 U-3547		03/26/2020
001	10799138	04/05/2039			U-3125 U-3549		06/11/2021
001	11583216	08/21/2039			U-3549		03/27/2023
001	11696902	08/14/2038			U-2769		07/31/2023

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration

 

 

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