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.
80 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
N205422 BREXPIPRAZOLE REXULTI TABLET ORAL 0.25MG 7888362 04/12/2026 DS RX 07/17/2015
N205422 BREXPIPRAZOLE REXULTI TABLET ORAL 0.5MG 7888362 04/12/2026 DS RX 07/17/2015
N205422 BREXPIPRAZOLE REXULTI TABLET ORAL 1MG 7888362 04/12/2026 DS RX 07/23/2015
N205422 BREXPIPRAZOLE REXULTI TABLET ORAL 2MG 7888362 04/12/2026 DS RX 07/23/2015
N205422 BREXPIPRAZOLE REXULTI TABLET ORAL 3MG 7888362 04/12/2026 DS RX 07/23/2015
N205422 BREXPIPRAZOLE REXULTI TABLET ORAL 4MG 7888362 04/12/2026 DS RX 07/23/2015
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
N208325 ETELCALCETIDE PARSABIV SOLUTION INTRAVENOUS 2.5MG/0.5ML (2.5MG/0.5ML) 10344765 06/27/2034 DP RX 07/19/2019
N208325 ETELCALCETIDE PARSABIV SOLUTION INTRAVENOUS 5MG/ML (5MG/ML) 10344765 06/27/2034 DP RX 07/19/2019
N208325 ETELCALCETIDE PARSABIV SOLUTION INTRAVENOUS 10MG/2ML (5MG/ML) 10344765 06/27/2034 DP RX 07/19/2019
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
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 150MG,N/A;150MG, 100MG 10022352 04/09/2027 DP U-2343 RX 08/08/2018
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 150MG,N/A;150MG, 100MG 10022352 04/09/2027 DP U-2573 RX 08/08/2018
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 75MG,N/A;75MG, 50MG 10022352 04/09/2027 DP U-2343 RX 07/17/2019
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 75MG,N/A;75MG, 50MG 10022352 04/09/2027 DP U-2573 RX 07/17/2019
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 150MG,N/A;150MG, 100MG 10058546 07/15/2033 U-2399 RX 09/21/2018
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 150MG,N/A;150MG, 100MG 10058546 07/15/2033 U-2572 RX 09/21/2018
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 75MG,N/A;75MG, 50MG 10058546 07/15/2033 U-2399 RX 07/17/2019
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 75MG,N/A;75MG, 50MG 10058546 07/15/2033 U-2572 RX 07/17/2019
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 150MG,N/A;150MG, 100MG 10081621 03/25/2031 DP U-2420 RX 10/25/2018
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 150MG,N/A;150MG, 100MG 10081621 03/25/2031 DP U-2571 RX 10/25/2018
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 75MG,N/A;75MG, 50MG 10081621 03/25/2031 DP U-2420 RX 07/17/2019
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 75MG,N/A;75MG, 50MG 10081621 03/25/2031 DP U-2571 RX 07/17/2019
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 150MG,N/A;150MG, 100MG 10206877 04/14/2035 DP U-2498 RX 03/20/2019
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 150MG,N/A;150MG, 100MG 10206877 04/14/2035 DP U-2570 RX 03/20/2019
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 75MG,N/A;75MG, 50MG 10206877 04/14/2035 DP U-2498 RX 07/17/2019
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 75MG,N/A;75MG, 50MG 10206877 04/14/2035 DP U-2570 RX 07/17/2019
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 150MG,N/A;150MG, 100MG 10239867 04/09/2027 DS DP U-2512 RX 04/19/2019
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 150MG,N/A;150MG, 100MG 10239867 04/09/2027 DS DP U-2569 RX 04/19/2019
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 75MG,N/A;75MG, 50MG 10239867 04/09/2027 DS DP U-2512 RX 07/17/2019
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 75MG,N/A;75MG, 50MG 10239867 04/09/2027 DS DP U-2569 RX 07/17/2019
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 75MG,N/A;75MG, 50MG 7495103 05/20/2027 DS DP RX 07/17/2019
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 75MG,N/A;75MG, 50MG 7645789 05/01/2027 DS DP RX 07/17/2019
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 75MG,N/A;75MG, 50MG 7776905 06/03/2027 DS DP RX 07/17/2019
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 75MG,N/A;75MG, 50MG 8324242 08/05/2027 U-2246 RX 07/17/2019
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 75MG,N/A;75MG, 50MG 8410274 12/28/2026 DP RX 07/17/2019
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 75MG,N/A;75MG, 50MG 8415387 11/12/2027 U-2246 RX 07/17/2019
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 75MG,N/A;75MG, 50MG 8598181 05/01/2027 U-2246 RX 07/17/2019
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 75MG,N/A;75MG, 50MG 8623905 05/01/2027 DS DP RX 07/17/2019
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 75MG,N/A;75MG, 50MG 8629162 06/24/2025 U-2247 RX 07/17/2019
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 75MG,N/A;75MG, 50MG 8754224 12/28/2026 DS DP RX 07/17/2019
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 75MG,N/A;75MG, 50MG 9012496 07/15/2033 U-2248 RX 07/17/2019
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 75MG,N/A;75MG, 50MG 9670163 12/28/2026 DP U-2246 RX 07/17/2019
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 150MG,N/A;150MG, 100MG 9931334 12/28/2026 DP U-2275 RX 05/01/2018
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 150MG,N/A;150MG, 100MG 9931334 12/28/2026 DP U-2575 RX 05/01/2018
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 75MG,N/A;75MG, 50MG 9931334 12/28/2026 DP U-2275 RX 07/17/2019
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 75MG,N/A;75MG, 50MG 9931334 12/28/2026 DP U-2575 RX 07/17/2019
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 150MG,N/A;150MG, 100MG 9974781 04/09/2027 DP U-2318 RX 06/20/2018
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 150MG,N/A;150MG, 100MG 9974781 04/09/2027 DP U-2574 RX 06/20/2018
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 75MG,N/A;75MG, 50MG 9974781 04/09/2027 DP U-2318 RX 07/17/2019
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 75MG,N/A;75MG, 50MG 9974781 04/09/2027 DP U-2574 RX 07/17/2019
N210598 REVEFENACIN YUPELRI SOLUTION INHALATION 175MCG/3ML 10343995 03/10/2025 U-2440 RX 07/15/2019

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Last Updated July 23, 2019.

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