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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: N020845

Product 003
NITRIC OXIDE (INOMAX) GAS 800PPM

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
003 8282966 06/30/2029 U-1286
003 8282966*PED 12/30/2029
003 8291904 01/06/2031 DP U-1226
003 8291904*PED 07/06/2031
003 8293284 06/30/2029 U-1286
003 8293284*PED 12/30/2029
003 8431163 06/30/2029 U-1286
003 8431163*PED 12/30/2029
003 8573209 01/06/2031 DP 12/04/2013
003 8573209*PED 07/06/2031
003 8573210 01/06/2031 DP U-1453 12/04/2013
003 8573210*PED 07/06/2031
003 8776794 01/06/2031 DP U-1226 07/23/2014
003 8776794*PED 07/06/2031
003 8776795 01/06/2031 DP U-1226 07/23/2014
003 8776795*PED 07/06/2031
003 8795741 06/30/2029 U-1286 08/07/2014
003 8795741*PED 12/30/2029
003 8846112 06/30/2029 U-1286 10/02/2014
003 8846112*PED 12/30/2029
003 9265911 01/06/2031 DP U-1824 03/18/2016
003 9265911*PED 07/06/2031
003 9279794 02/19/2034 DP U-1823 03/18/2016
003 9279794*PED 08/19/2034
003 9295802 01/06/2031 DP U-1226 04/06/2016
003 9295802*PED 07/06/2031
003 9408993 01/06/2031 DP U-1824 08/17/2016
003 9408993*PED 07/06/2031
003 9770570 05/03/2036 U-2148 10/25/2017
003 9770570*PED 11/03/2036
003 11931377 06/03/2029 DS DP U-3903 05/06/2024
003 11931377*PED 12/03/2029

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration

 

 


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