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: N206439

Product 001
DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE (NAMZARIC) CAPSULE, EXTENDED RELEASE 10MG;14MG

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 8039009 03/24/2029
U-1641 MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
001 8039009*PED 09/24/2029
001 8058291 12/05/2029
U-1641 MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
01/22/2015
001 8168209 11/22/2025 DP
01/22/2015
001 8168209*PED 05/22/2026
001 8173708 11/22/2025
U-1641 MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
01/22/2015
001 8173708*PED 05/22/2026
001 8283379 11/22/2025
U-1641 MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
01/22/2015
001 8283379*PED 05/22/2026
001 8293794 11/22/2025 DP
01/22/2015
001 8329752 11/22/2025 DP
08/16/2016
001 8329752*PED 05/22/2026
001 8338485 11/22/2025 DP
08/16/2016
001 8338486 11/22/2025
U-1641 MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
08/16/2016
001 8362085 11/22/2025
U-1641 MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
08/16/2016
001 8362085*PED 05/22/2026
001 8580858 11/22/2025
U-1641 MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
08/16/2016
001 8598233 11/22/2025 DP
08/16/2016
001 8598233*PED 05/22/2026

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration

 

 


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