Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Product Details

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: N022517

Product 002
DESMOPRESSIN ACETATE (NOCDURNA) TABLET 0.0553MG

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
002 7560429 02/02/2024 DP
U-2326 TREATMENT OF NOCTURIA DUE TO NOCTURNAL POLYURIA IN ADULTS
07/19/2018
002 7947654 12/29/2023 DP
07/25/2018
002 8802624 12/29/2023
U-2326 TREATMENT OF NOCTURIA DUE TO NOCTURNAL POLYURIA IN ADULTS
07/19/2018
002 9220747 05/07/2023
U-2326 TREATMENT OF NOCTURIA DUE TO NOCTURNAL POLYURIA IN ADULTS
07/19/2018
002 9504647 05/07/2023 DP
U-2326 TREATMENT OF NOCTURIA DUE TO NOCTURNAL POLYURIA IN ADULTS
07/19/2018
002 9919025 05/07/2023
U-2326 TREATMENT OF NOCTURIA DUE TO NOCTURNAL POLYURIA IN ADULTS
07/19/2018
002 9974826 04/13/2030
U-2327 TREATMENT OF NOCTURIA DUE TO NOCTURNAL POLYURIA IN ADULTS, COMPRISING MONITORING A PATIENT'S SERUM SODIUM CONCENTRATION
07/19/2018
002 10137167 05/21/2029
U-2327 TREATMENT OF NOCTURIA DUE TO NOCTURNAL POLYURIA IN ADULTS, COMPRISING MONITORING A PATIENT'S SERUM SODIUM CONCENTRATION
12/12/2018
002 10307459 05/07/2023 DP
08/12/2019

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
002
NPNEW PRODUCT
COMPETITIVE GENERIC THERAPY
06/21/2021

 

 


View a list of all patent use codes
View a list of all exclusivity codes

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English