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: N202860

Product 001
NITRIC OXIDE (GENOSYL) GAS 800PPM

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 6758214 02/23/2022 DP
06/10/2020
001 7560076 04/21/2027 DP
06/10/2020
001 7618594 10/17/2026 DP
06/10/2020
001 7947227 10/17/2026
U-3037 A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT
01/15/2021
001 8057742 01/18/2026
U-3037 A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT
01/15/2021
001 8226916 08/18/2025
U-3037 A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT
01/15/2021
001 8607785 07/14/2030 DP
01/15/2021
001 8609028 08/18/2025
U-3037 A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT
01/15/2021
001 8821801 08/18/2025 DP
01/15/2021
001 8944049 08/13/2029 DP
01/15/2021
001 9522249 08/18/2025 DP
01/15/2021
001 9604028 08/13/2029
U-2793 A METHOD FOR DELIVERING NITRIC OXIDE TO A PATIENT WITH PULMONARY HYPERTENSION OR HYPOXIA
05/05/2020
001 9701538 01/28/2029 DP
01/15/2021
001 9956373 08/18/2025
U-3037 A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT
01/15/2021
001 10124142 08/18/2025
U-3037 A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT
01/15/2021
001 10213572 02/12/2036 DP
05/05/2020
001 10737051 10/20/2035 DP
08/21/2020
001 10814092 10/17/2025
U-3037 A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT
01/15/2021
001 10926054 08/13/2029 DP
03/09/2021

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration

 

 


View a list of all patent use codes
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