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.
87 records returned
Appl No Active Ingredient Proprietary Name Dosage Form Route Strength Patent No Patent Expiration Date Drug Substance Claim Drug Product Claim Patent Use Code Delist Requested Mkt. Status
Appl No Active Ingredient Proprietary Name Dosage Form Route Strength Patent No Patent Expiration Date Drug Substance Claim Drug Product Claim Patent Use Code Delist Requested Mkt. Status
N021344 FULVESTRANT FASLODEX INJECTABLE INTRAMUSCULAR 50MG/ML 6774122 Jan 9, 2021 U-596 RX
N021344 FULVESTRANT FASLODEX INJECTABLE INTRAMUSCULAR 50MG/ML 6774122 Jan 9, 2021 U-1826 RX
N021344 FULVESTRANT FASLODEX INJECTABLE INTRAMUSCULAR 50MG/ML 6774122 Jan 9, 2021 U-2108 RX
N021344 FULVESTRANT FASLODEX INJECTABLE INTRAMUSCULAR 50MG/ML 6774122*PED Jul 9, 2021 RX
N021344 FULVESTRANT FASLODEX INJECTABLE INTRAMUSCULAR 50MG/ML 7456160 Jan 9, 2021 U-596 RX
N021344 FULVESTRANT FASLODEX INJECTABLE INTRAMUSCULAR 50MG/ML 7456160 Jan 9, 2021 U-1826 RX
N021344 FULVESTRANT FASLODEX INJECTABLE INTRAMUSCULAR 50MG/ML 7456160 Jan 9, 2021 U-2108 RX
N021344 FULVESTRANT FASLODEX INJECTABLE INTRAMUSCULAR 50MG/ML 7456160*PED Jul 9, 2021 RX
N021344 FULVESTRANT FASLODEX INJECTABLE INTRAMUSCULAR 50MG/ML 8329680 Jan 9, 2021 U-596 RX
N021344 FULVESTRANT FASLODEX INJECTABLE INTRAMUSCULAR 50MG/ML 8329680 Jan 9, 2021 U-1826 RX
N021344 FULVESTRANT FASLODEX INJECTABLE INTRAMUSCULAR 50MG/ML 8329680 Jan 9, 2021 U-2108 RX
N021344 FULVESTRANT FASLODEX INJECTABLE INTRAMUSCULAR 50MG/ML 8329680*PED Jul 9, 2021 RX
N021344 FULVESTRANT FASLODEX INJECTABLE INTRAMUSCULAR 50MG/ML 8466139 Jan 9, 2021 U-596 RX
N021344 FULVESTRANT FASLODEX INJECTABLE INTRAMUSCULAR 50MG/ML 8466139 Jan 9, 2021 U-1826 RX
N021344 FULVESTRANT FASLODEX INJECTABLE INTRAMUSCULAR 50MG/ML 8466139 Jan 9, 2021 U-2108 RX
N021344 FULVESTRANT FASLODEX INJECTABLE INTRAMUSCULAR 50MG/ML 8466139*PED Jul 9, 2021 RX
N021398 BRIMONIDINE TARTRATE; TIMOLOL MALEATE COMBIGAN SOLUTION/DROPS OPHTHALMIC 0.2%;EQ 0.5% BASE 9770453 Apr 19, 2022 DP U-2131 RX
N022257 VALGANCICLOVIR HYDROCHLORIDE VALCYTE FOR SOLUTION ORAL 50MG/ML 8889109 Dec 11, 2027 DP RX
N201656 DESMOPRESSIN ACETATE NOCTIVA SPRAY, METERED NASAL 0.00166MG/SPRAY 7799761 Sep 26, 2024 DP Y RX
N205109 SUCROFERRIC OXYHYDROXIDE VELPHORO TABLET, CHEWABLE ORAL 500MG 6174442 Dec 19, 2018 DS U-1468 RX
N205836 BRIVARACETAM BRIVIACT TABLET ORAL 10MG 6784197 Feb 21, 2021 DS DP U-1815 RX
N205836 BRIVARACETAM BRIVIACT TABLET ORAL 10MG 6784197 Feb 21, 2021 DS DP U-2130 RX
N205836 BRIVARACETAM BRIVIACT TABLET ORAL 25MG 6784197 Feb 21, 2021 DS DP U-1815 RX
N205836 BRIVARACETAM BRIVIACT TABLET ORAL 25MG 6784197 Feb 21, 2021 DS DP U-2130 RX
N205836 BRIVARACETAM BRIVIACT TABLET ORAL 50MG 6784197 Feb 21, 2021 DS DP U-1815 RX
N205836 BRIVARACETAM BRIVIACT TABLET ORAL 50MG 6784197 Feb 21, 2021 DS DP U-2130 RX
N205836 BRIVARACETAM BRIVIACT TABLET ORAL 75MG 6784197 Feb 21, 2021 DS DP U-1815 RX
N205836 BRIVARACETAM BRIVIACT TABLET ORAL 75MG 6784197 Feb 21, 2021 DS DP U-2130 RX
N205836 BRIVARACETAM BRIVIACT TABLET ORAL 100MG 6784197 Feb 21, 2021 DS DP U-1815 RX
N205836 BRIVARACETAM BRIVIACT TABLET ORAL 100MG 6784197 Feb 21, 2021 DS DP U-2130 RX
N205836 BRIVARACETAM BRIVIACT TABLET ORAL 10MG 6911461 Feb 21, 2021 DS DP U-1815 RX
N205836 BRIVARACETAM BRIVIACT TABLET ORAL 10MG 6911461 Feb 21, 2021 DS DP U-2130 RX
N205836 BRIVARACETAM BRIVIACT TABLET ORAL 25MG 6911461 Feb 21, 2021 DS DP U-1815 RX
N205836 BRIVARACETAM BRIVIACT TABLET ORAL 25MG 6911461 Feb 21, 2021 DS DP U-2130 RX
N205836 BRIVARACETAM BRIVIACT TABLET ORAL 50MG 6911461 Feb 21, 2021 DS DP U-1815 RX
N205836 BRIVARACETAM BRIVIACT TABLET ORAL 50MG 6911461 Feb 21, 2021 DS DP U-2130 RX
N205836 BRIVARACETAM BRIVIACT TABLET ORAL 75MG 6911461 Feb 21, 2021 DS DP U-1815 RX
N205836 BRIVARACETAM BRIVIACT TABLET ORAL 75MG 6911461 Feb 21, 2021 DS DP U-2130 RX
N205836 BRIVARACETAM BRIVIACT TABLET ORAL 100MG 6911461 Feb 21, 2021 DS DP U-1815 RX
N205836 BRIVARACETAM BRIVIACT TABLET ORAL 100MG 6911461 Feb 21, 2021 DS DP U-2130 RX
N205836 BRIVARACETAM BRIVIACT TABLET ORAL 10MG 8492416 Feb 21, 2021 U-1815 RX
N205836 BRIVARACETAM BRIVIACT TABLET ORAL 10MG 8492416 Feb 21, 2021 U-2130 RX
N205836 BRIVARACETAM BRIVIACT TABLET ORAL 25MG 8492416 Feb 21, 2021 U-1815 RX
N205836 BRIVARACETAM BRIVIACT TABLET ORAL 25MG 8492416 Feb 21, 2021 U-2130 RX
N205836 BRIVARACETAM BRIVIACT TABLET ORAL 50MG 8492416 Feb 21, 2021 U-1815 RX
N205836 BRIVARACETAM BRIVIACT TABLET ORAL 50MG 8492416 Feb 21, 2021 U-2130 RX
N205836 BRIVARACETAM BRIVIACT TABLET ORAL 75MG 8492416 Feb 21, 2021 U-1815 RX
N205836 BRIVARACETAM BRIVIACT TABLET ORAL 75MG 8492416 Feb 21, 2021 U-2130 RX
N205836 BRIVARACETAM BRIVIACT TABLET ORAL 100MG 8492416 Feb 21, 2021 U-1815 RX
N205836 BRIVARACETAM BRIVIACT TABLET ORAL 100MG 8492416 Feb 21, 2021 U-2130 RX
N208079 BETAMETHASONE DIPROPIONATE SERNIVO SPRAY TOPICAL EQ 0.05% BASE/SPRAY 9775851 Aug 31, 2030 DP U-1858 RX
N208716 ABEMACICLIB VERZENIO TABLET ORAL 50MG 7855211 Dec 15, 2029 DS DP U-2132 RX
N208716 ABEMACICLIB VERZENIO TABLET ORAL 50MG 7855211 Dec 15, 2029 DS DP U-2135 RX
N208716 ABEMACICLIB VERZENIO TABLET ORAL 100MG 7855211 Dec 15, 2029 DS DP U-2132 RX
N208716 ABEMACICLIB VERZENIO TABLET ORAL 100MG 7855211 Dec 15, 2029 DS DP U-2135 RX
N208716 ABEMACICLIB VERZENIO TABLET ORAL 150MG 7855211 Dec 15, 2029 DS DP U-2132 RX
N208716 ABEMACICLIB VERZENIO TABLET ORAL 150MG 7855211 Dec 15, 2029 DS DP U-2135 RX
N208716 ABEMACICLIB VERZENIO TABLET ORAL 200MG 7855211 Dec 15, 2029 DS DP U-2132 RX
N208716 ABEMACICLIB VERZENIO TABLET ORAL 200MG 7855211 Dec 15, 2029 DS DP U-2135 RX
N209022 FLUTICASONE PROPIONATE XHANCE SPRAY, METERED NASAL 0.093MG 6715485 Mar 3, 2020 DP RX
N209022 FLUTICASONE PROPIONATE XHANCE SPRAY, METERED NASAL 0.093MG 7975690 Dec 29, 2025 U-2133 RX
N209022 FLUTICASONE PROPIONATE XHANCE SPRAY, METERED NASAL 0.093MG 8327844 Oct 8, 2023 U-2133 RX
N209022 FLUTICASONE PROPIONATE XHANCE SPRAY, METERED NASAL 0.093MG 8522778 May 11, 2022 DP RX
N209022 FLUTICASONE PROPIONATE XHANCE SPRAY, METERED NASAL 0.093MG 8550073 Oct 22, 2029 DP RX
N209022 FLUTICASONE PROPIONATE XHANCE SPRAY, METERED NASAL 0.093MG 8555878 Mar 20, 2020 DP RX
N209022 FLUTICASONE PROPIONATE XHANCE SPRAY, METERED NASAL 0.093MG 8978647 Aug 6, 2030 DP RX
N209022 FLUTICASONE PROPIONATE XHANCE SPRAY, METERED NASAL 0.093MG 9072857 Apr 10, 2021 DP RX
N209022 FLUTICASONE PROPIONATE XHANCE SPRAY, METERED NASAL 0.093MG 9468727 Jul 30, 2020 DP RX
N209482 FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE TRELEGY ELLIPTA POWDER INHALATION 0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH 6537983 Aug 3, 2021 DP U-2125 RX
N209482 FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE TRELEGY ELLIPTA POWDER INHALATION 0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH 6759398 Aug 3, 2021 DP U-2125 RX
N209482 FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE TRELEGY ELLIPTA POWDER INHALATION 0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH 6878698 Aug 3, 2021 U-2134 RX
N209482 FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE TRELEGY ELLIPTA POWDER INHALATION 0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH 7101866 Aug 3, 2021 DS DP U-2126 RX
N209482 FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE TRELEGY ELLIPTA POWDER INHALATION 0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH 7439393 May 21, 2025 DS DP U-2127 RX
N209482 FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE TRELEGY ELLIPTA POWDER INHALATION 0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH 7488827 Dec 18, 2027 DS DP RX
N209482 FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE TRELEGY ELLIPTA POWDER INHALATION 0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH 7498440 Apr 27, 2025 DS DP RX
N209482 FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE TRELEGY ELLIPTA POWDER INHALATION 0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH 7629335 Aug 3, 2021 DP RX
N209482 FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE TRELEGY ELLIPTA POWDER INHALATION 0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH 7776895 Sep 11, 2022 DP RX
N209482 FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE TRELEGY ELLIPTA POWDER INHALATION 0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH 8113199 Oct 23, 2027 DP RX
N209482 FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE TRELEGY ELLIPTA POWDER INHALATION 0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH 8161968 Feb 5, 2028 DP RX
N209482 FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE TRELEGY ELLIPTA POWDER INHALATION 0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH 8183257 Jul 27, 2025 U-2128 RX
N209482 FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE TRELEGY ELLIPTA POWDER INHALATION 0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH 8309572 Apr 27, 2025 U-2129 RX
N209482 FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE TRELEGY ELLIPTA POWDER INHALATION 0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH 8511304 Jun 14, 2027 DP RX
N209482 FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE TRELEGY ELLIPTA POWDER INHALATION 0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH 8534281 Aug 10, 2029 DP RX
N209482 FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE TRELEGY ELLIPTA POWDER INHALATION 0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH 8746242 Oct 11, 2030 DP RX
N209482 FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE TRELEGY ELLIPTA POWDER INHALATION 0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH 9333310 Oct 2, 2027 DP RX
N209482 FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE TRELEGY ELLIPTA POWDER INHALATION 0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH 9750762 Nov 29, 2030 DP RX
N209482 FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE TRELEGY ELLIPTA POWDER INHALATION 0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH RE44874 Mar 23, 2023 DS DP U-2127 RX

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Last Updated October 20, 2017.

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