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 002
METHYLPHENIDATE HYDROCHLORIDE (ADHANSIA XR) CAPSULE, EXTENDED RELEASE 35MG

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
002 9974752 10/30/2035 DP
03/08/2019
002 10111839 10/30/2035
U-2357 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
03/08/2019
002 10292938 10/30/2035 DP
05/22/2019
002 10292939 10/30/2035 DP
U-2357 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
05/22/2019
002 10449159 10/30/2035
U-2357 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
10/22/2019
002 10500162 10/30/2035
U-2357 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
12/11/2019
002 10507186 10/30/2035 DP
12/18/2019
002 10512612 10/30/2035 DP
01/02/2020
002 10512613 10/30/2035
U-2357 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
01/02/2020
002 10568841 10/30/2035 DP
U-2357 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
02/26/2020
002 10688060 10/30/2035 DP
06/23/2020
002 10722473 11/19/2038
U-2357 METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
07/28/2020

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
002
NPNEW PRODUCT
COMPETITIVE GENERIC THERAPY
02/27/2022

 

 


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