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: N207960

Product 003
METHYLPHENIDATE HYDROCHLORIDE (QUILLICHEW ER) TABLET, EXTENDED RELEASE, CHEWABLE 40MG

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
003	8202537	03/15/2027		DP			12/23/2015
003	8287903	02/15/2031		DP			12/23/2015
003	8999386	08/14/2033		DP			12/23/2015
003	9295642	08/14/2033		DP	U-1827		04/01/2016
003	9545399	08/14/2033		DP	U-1827		01/30/2017
003	9844544	08/14/2033		DP	U-2203		12/21/2017
003	10857143	08/14/2033		DP	U-2993		12/08/2020
003	11103494	08/14/2033		DP			08/31/2021
003	11103495	08/14/2033		DP	U-2993		08/31/2021
003	11633389	08/14/2033		DP			05/09/2023

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration

 

 

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