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: N212038

Product 006
METHYLPHENIDATE HYDROCHLORIDE (ADHANSIA XR) CAPSULE, EXTENDED RELEASE 85MG

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
006	9974752	10/30/2035		DP			03/08/2019
006	10111839	10/30/2035			U-2357		03/08/2019
006	10292938	10/30/2035		DP			05/22/2019
006	10292939	10/30/2035		DP	U-2357		05/22/2019
006	10449159	10/30/2035			U-2357		10/22/2019
006	10500162	10/30/2035			U-2357		12/11/2019
006	10507186	10/30/2035		DP			12/18/2019
006	10512612	10/30/2035		DP			01/02/2020
006	10512613	10/30/2035			U-2357		01/02/2020
006	10568841	10/30/2035		DP	U-2357		02/26/2020
006	10688060	10/30/2035		DP			06/23/2020
006	10722473	11/19/2038			U-2357		07/28/2020

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration
006	M-82	06/28/2024

 

 

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