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: 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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