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: N022063

Product 004
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE (MYDAYIS) CAPSULE, EXTENDED RELEASE 12.5MG;12.5MG;12.5MG;12.5MG

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
004 6913768 05/24/2023 DP
U-2025 TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER
07/07/2017
004 8846100 08/24/2029 DP
07/07/2017
004 9173857 05/12/2026
U-2025 TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER
07/07/2017

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
004
M-248INFORMATION ADDED TO THE LABELING TO DESCRIBE A TRIAL EVALUATING A LOWER DOSE THAN THOSE APPROVED FOR PEDIATRIC PATIENTS 13 TO 17 YEARS OF AGE
COMPETITIVE GENERIC THERAPY
09/13/2022
004
M-248INFORMATION ADDED TO THE LABELING TO DESCRIBE A TRIAL EVALUATING A LOWER DOSE THAN THOSE APPROVED FOR PEDIATRIC PATIENTS 13 TO 17 YEARS OF AGE
*PED PEDIATRIC EXCLUSIVITY
03/13/2023

 

 


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