Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Newly Added Patents

About This List
  • This screen lists the current month's NEW ADDITIONS or NEW CHANGES to the patents for drugs listed in the Orange Book.
  • This list will be purged after the Cumulative Supplement to the Orange Book is published on the first day of the next month. All the information listed on this screen is also available by using the other Orange Book search methods, such as searching by Proprietary Name.
  • Patents will remain available in the Orange Book even when they are no longer listed as NEW additions or NEW changes.
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.
31 records returned
Appl No Active Ingredient Proprietary Name Dosage Form Route Strength Patent No Patent Expire Date Drug Substance Drug Product Patent Use Code Delist Requested Mkt. Status Submission Date
Appl No Active Ingredient Proprietary Name Dosage Form Route Strength Patent No Patent Expire Date Drug Substance Drug Product Patent Use Code Delist Requested Mkt. Status Submission Date
N021829 ROTIGOTINE NEUPRO FILM, EXTENDED RELEASE TRANSDERMAL 2MG/24HR 10350174 12/22/2030 DP RX 07/18/2019
N021829 ROTIGOTINE NEUPRO FILM, EXTENDED RELEASE TRANSDERMAL 4MG/24HR 10350174 12/22/2030 DP RX 07/18/2019
N021829 ROTIGOTINE NEUPRO FILM, EXTENDED RELEASE TRANSDERMAL 6MG/24HR 10350174 12/22/2030 DP RX 07/18/2019
N021829 ROTIGOTINE NEUPRO FILM, EXTENDED RELEASE TRANSDERMAL 1MG/24HR 10350174 12/22/2030 DP RX 07/18/2019
N021829 ROTIGOTINE NEUPRO FILM, EXTENDED RELEASE TRANSDERMAL 3MG/24HR 10350174 12/22/2030 DP RX 07/18/2019
N021829 ROTIGOTINE NEUPRO FILM, EXTENDED RELEASE TRANSDERMAL 8MG/24HR 10350174 12/22/2030 DP RX 07/18/2019
N201688 TOBRAMYCIN TOBI PODHALER POWDER INHALATION 28MG 10207066 11/04/2030 DP U-909 RX 06/17/2019
N201688 TOBRAMYCIN TOBI PODHALER POWDER INHALATION 28MG 8664187 06/20/2025 U-909 RX 06/17/2019
N201688 TOBRAMYCIN TOBI PODHALER POWDER INHALATION 28MG 8869794 09/12/2028 DP U-909 RX 06/17/2019
N201688 TOBRAMYCIN TOBI PODHALER POWDER INHALATION 28MG 9421166 12/19/2022 DP U-909 RX 06/17/2019
N202880 HYDROCODONE BITARTRATE ZOHYDRO ER CAPSULE, EXTENDED RELEASE ORAL 10MG 10322120 07/25/2033 DP RX 07/17/2019
N202880 HYDROCODONE BITARTRATE ZOHYDRO ER CAPSULE, EXTENDED RELEASE ORAL 15MG 10322120 07/25/2033 DP RX 07/17/2019
N202880 HYDROCODONE BITARTRATE ZOHYDRO ER CAPSULE, EXTENDED RELEASE ORAL 20MG 10322120 07/25/2033 DP RX 07/17/2019
N202880 HYDROCODONE BITARTRATE ZOHYDRO ER CAPSULE, EXTENDED RELEASE ORAL 30MG 10322120 07/25/2033 DP RX 07/17/2019
N202880 HYDROCODONE BITARTRATE ZOHYDRO ER CAPSULE, EXTENDED RELEASE ORAL 40MG 10322120 07/25/2033 DP RX 07/17/2019
N202880 HYDROCODONE BITARTRATE ZOHYDRO ER CAPSULE, EXTENDED RELEASE ORAL 50MG 10322120 07/25/2033 DP RX 07/17/2019
N203684 SULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERES LUMASON FOR SUSPENSION INTRAVENOUS 60.7MG/25MG 10335502 07/06/2038 DP RX 07/16/2019
N207589 BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE ENSTILAR AEROSOL, FOAM TOPICAL 0.064%;0.005% 10130640 06/10/2031 DP RX 12/06/2018
N207589 BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE ENSTILAR AEROSOL, FOAM TOPICAL 0.064%;0.005% 10130640*PED 12/10/2031 RX
N207589 BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE ENSTILAR AEROSOL, FOAM TOPICAL 0.064%;0.005% 9119781 06/10/2031 DP U-1761 RX 11/12/2015
N207589 BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE ENSTILAR AEROSOL, FOAM TOPICAL 0.064%;0.005% 9119781*PED 12/10/2031 RX
N209091 DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE QTERN TABLET ORAL 10MG;EQ 5MG BASE 6414126 10/04/2020 DS DP U-493 RX 03/22/2017
N209091 DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE QTERN TABLET ORAL 10MG;EQ 5MG BASE 6515117 10/04/2020 DS DP U-493 RX 03/22/2017
N209091 DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE QTERN TABLET ORAL 10MG;EQ 5MG BASE RE44186 07/31/2023 DS DP U-493 RX 03/22/2017
N209360 ANGIOTENSIN II ACETATE GIAPREZA SOLUTION INTRAVENOUS EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML) 9572856 11/20/2030 U-2221 RX 01/22/2018
N209360 ANGIOTENSIN II ACETATE GIAPREZA SOLUTION INTRAVENOUS EQ 5MG BASE/2ML (EQ 2.5MG BASE/ML) 9572856 11/20/2030 U-2221 DISCN 01/22/2018
N209449 NITISINONE NITYR TABLET ORAL 2MG 10328029 01/05/2035 DP U-1836 RX 07/17/2019
N209449 NITISINONE NITYR TABLET ORAL 5MG 10328029 01/05/2035 DP U-1836 RX 07/17/2019
N209449 NITISINONE NITYR TABLET ORAL 10MG 10328029 01/05/2035 DP U-1836 RX 07/17/2019
N209589 CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE CLENPIQ SOLUTION ORAL 12GM/BOT;3.5GM/BOT;10MG/BOT 9827231 06/26/2034 DP U-2162 RX 12/06/2017
N210598 REVEFENACIN YUPELRI SOLUTION INHALATION 175MCG/3ML 10343995 03/10/2025 U-2440 RX 07/15/2019

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

Last Updated July 19, 2019.

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