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.
37 records returned
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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
N021752 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TRUVADA TABLET ORAL 100MG;150MG 6642245 Nov 4, 2020 U-248 RX
N021752 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TRUVADA TABLET ORAL 100MG;150MG 6642245 Nov 4, 2020 U-541 RX
N021752 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TRUVADA TABLET ORAL 100MG;150MG 6642245 Nov 4, 2020 U-1170 RX
N021752 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TRUVADA TABLET ORAL 133MG;200MG 6642245 Nov 4, 2020 U-248 RX
N021752 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TRUVADA TABLET ORAL 133MG;200MG 6642245 Nov 4, 2020 U-541 RX
N021752 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TRUVADA TABLET ORAL 133MG;200MG 6642245 Nov 4, 2020 U-1170 RX
N021752 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TRUVADA TABLET ORAL 167MG;250MG 6642245 Nov 4, 2020 U-248 RX
N021752 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TRUVADA TABLET ORAL 167MG;250MG 6642245 Nov 4, 2020 U-541 RX
N021752 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TRUVADA TABLET ORAL 167MG;250MG 6642245 Nov 4, 2020 U-1170 RX
N021752 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TRUVADA TABLET ORAL 100MG;150MG 6642245*PED May 4, 2021 RX
N021752 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TRUVADA TABLET ORAL 133MG;200MG 6642245*PED May 4, 2021 RX
N021752 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TRUVADA TABLET ORAL 167MG;250MG 6642245*PED May 4, 2021 RX
N022369 BIMATOPROST LATISSE SOLUTION/DROPS TOPICAL 0.03% 9579270 Jan 31, 2021 U-1975 RX
N022416 ESLICARBAZEPINE ACETATE APTIOM TABLET ORAL 200MG 9566244 Oct 23, 2028 DP RX
N022416 ESLICARBAZEPINE ACETATE APTIOM TABLET ORAL 400MG 9566244 Oct 23, 2028 DP RX
N022416 ESLICARBAZEPINE ACETATE APTIOM TABLET ORAL 600MG 9566244 Oct 23, 2028 DP RX
N022416 ESLICARBAZEPINE ACETATE APTIOM TABLET ORAL 800MG 9566244 Oct 23, 2028 DP RX
N203441 TEDUGLUTIDE RECOMBINANT GATTEX KIT POWDER SUBCUTANEOUS 5MG/VIAL 9592273 Nov 1, 2025 U-1320 RX
N203441 TEDUGLUTIDE RECOMBINANT GATTEX KIT POWDER SUBCUTANEOUS 5MG/VIAL 9592274 Nov 1, 2025 U-1320 RX
N204427 TAVABOROLE KERYDIN SOLUTION TOPICAL 5% 9572823 Feb 16, 2026 U-1970 RX
N206627 HYDROCODONE BITARTRATE HYSINGLA TABLET, EXTENDED RELEASE ORAL 20MG 9572804 Oct 30, 2021 DP RX
N206627 HYDROCODONE BITARTRATE HYSINGLA TABLET, EXTENDED RELEASE ORAL 30MG 9572804 Oct 30, 2021 DP RX
N206627 HYDROCODONE BITARTRATE HYSINGLA TABLET, EXTENDED RELEASE ORAL 40MG 9572804 Oct 30, 2021 DP RX
N206627 HYDROCODONE BITARTRATE HYSINGLA TABLET, EXTENDED RELEASE ORAL 60MG 9572804 Oct 30, 2021 DP RX
N206627 HYDROCODONE BITARTRATE HYSINGLA TABLET, EXTENDED RELEASE ORAL 80MG 9572804 Oct 30, 2021 DP RX
N206627 HYDROCODONE BITARTRATE HYSINGLA TABLET, EXTENDED RELEASE ORAL 100MG 9572804 Oct 30, 2021 DP RX
N206627 HYDROCODONE BITARTRATE HYSINGLA TABLET, EXTENDED RELEASE ORAL 120MG 9572804 Oct 30, 2021 DP RX
N208090 OXYCODONE XTAMPZA ER CAPSULE, EXTENDED RELEASE ORAL 9MG 9592200 Jul 7, 2023 DP RX
N208090 OXYCODONE XTAMPZA ER CAPSULE, EXTENDED RELEASE ORAL 13.5MG 9592200 Jul 7, 2023 DP RX
N208090 OXYCODONE XTAMPZA ER CAPSULE, EXTENDED RELEASE ORAL 18MG 9592200 Jul 7, 2023 DP RX
N208090 OXYCODONE XTAMPZA ER CAPSULE, EXTENDED RELEASE ORAL 27MG 9592200 Jul 7, 2023 DP RX
N208090 OXYCODONE XTAMPZA ER CAPSULE, EXTENDED RELEASE ORAL 36MG 9592200 Jul 7, 2023 DP RX
N208194 BENDAMUSTINE HYDROCHLORIDE BENDEKA SOLUTION IV (INFUSION) 100MG/4ML (25MG/ML) 9597397 Mar 15, 2033 U-1971 RX
N208194 BENDAMUSTINE HYDROCHLORIDE BENDEKA SOLUTION IV (INFUSION) 100MG/4ML (25MG/ML) 9597397 Mar 15, 2033 U-1972 RX
N208194 BENDAMUSTINE HYDROCHLORIDE BENDEKA SOLUTION IV (INFUSION) 100MG/4ML (25MG/ML) 9597398 Mar 15, 2033 U-1971 RX
N208194 BENDAMUSTINE HYDROCHLORIDE BENDEKA SOLUTION IV (INFUSION) 100MG/4ML (25MG/ML) 9597399 Mar 15, 2033 U-1971 RX
N208194 BENDAMUSTINE HYDROCHLORIDE BENDEKA SOLUTION IV (INFUSION) 100MG/4ML (25MG/ML) 9597399 Mar 15, 2033 U-1972 RX

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

Last Updated March 28, 2017.

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