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.
38 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
N021937 EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE ATRIPLA TABLET ORAL 600MG;200MG;300MG 8598185 Apr 28, 2029 DP RX
N202324 AXITINIB INLYTA TABLET ORAL 1MG 8791140 Dec 14, 2030 DS RX
N202324 AXITINIB INLYTA TABLET ORAL 5MG 8791140 Dec 14, 2030 DS RX
N204820 COLCHICINE MITIGARE CAPSULE ORAL 0.6MG 9675613 Aug 22, 2033 U-1020 RX
N205755 CERITINIB ZYKADIA CAPSULE ORAL 150MG 8188276 Jan 31, 2023 DS DP RX
N205755 CERITINIB ZYKADIA CAPSULE ORAL 150MG 8399450 Nov 20, 2027 DS DP RX
N205755 CERITINIB ZYKADIA CAPSULE ORAL 150MG 8835430 Jan 31, 2023 DS DP RX
N205755 CERITINIB ZYKADIA CAPSULE ORAL 150MG 9018204 Jan 31, 2023 DS DP RX
N205755 CERITINIB ZYKADIA CAPSULE ORAL 150MG 9416112 Jan 31, 2023 DS DP RX
N206619 DASABUVIR SODIUM ; OMBITASVIR; PARITAPREVIR; RITONAVIR VIEKIRA PAK (COPACKAGED) TABLET, TABLET ORAL EQ 250MG BASE,N/A,N/A,N/A; N/A,12.5MG,75MG,50MG 9629841 Oct 18, 2033 DP U-1753 RX
N206627 HYDROCODONE BITARTRATE HYSINGLA TABLET, EXTENDED RELEASE ORAL 20MG 9669023 Oct 30, 2020 DP RX
N206627 HYDROCODONE BITARTRATE HYSINGLA TABLET, EXTENDED RELEASE ORAL 30MG 9669023 Oct 30, 2020 DP RX
N206627 HYDROCODONE BITARTRATE HYSINGLA TABLET, EXTENDED RELEASE ORAL 40MG 9669023 Oct 30, 2020 DP RX
N206627 HYDROCODONE BITARTRATE HYSINGLA TABLET, EXTENDED RELEASE ORAL 60MG 9669023 Oct 30, 2020 DP RX
N206627 HYDROCODONE BITARTRATE HYSINGLA TABLET, EXTENDED RELEASE ORAL 80MG 9669023 Oct 30, 2020 DP RX
N206627 HYDROCODONE BITARTRATE HYSINGLA TABLET, EXTENDED RELEASE ORAL 100MG 9669023 Oct 30, 2020 DP RX
N206627 HYDROCODONE BITARTRATE HYSINGLA TABLET, EXTENDED RELEASE ORAL 120MG 9669023 Oct 30, 2020 DP RX
N206627 HYDROCODONE BITARTRATE HYSINGLA TABLET, EXTENDED RELEASE ORAL 20MG 9675611 Oct 30, 2020 U-1556 RX
N206627 HYDROCODONE BITARTRATE HYSINGLA TABLET, EXTENDED RELEASE ORAL 30MG 9675611 Oct 30, 2020 U-1556 RX
N206627 HYDROCODONE BITARTRATE HYSINGLA TABLET, EXTENDED RELEASE ORAL 40MG 9675611 Oct 30, 2020 U-1556 RX
N206627 HYDROCODONE BITARTRATE HYSINGLA TABLET, EXTENDED RELEASE ORAL 60MG 9675611 Oct 30, 2020 U-1556 RX
N206627 HYDROCODONE BITARTRATE HYSINGLA TABLET, EXTENDED RELEASE ORAL 80MG 9675611 Oct 30, 2020 U-1556 RX
N206627 HYDROCODONE BITARTRATE HYSINGLA TABLET, EXTENDED RELEASE ORAL 100MG 9675611 Oct 30, 2020 U-1556 RX
N206627 HYDROCODONE BITARTRATE HYSINGLA TABLET, EXTENDED RELEASE ORAL 120MG 9675611 Oct 30, 2020 U-1556 RX
N206627 HYDROCODONE BITARTRATE HYSINGLA TABLET, EXTENDED RELEASE ORAL 20MG 9682077 Oct 30, 2020 U-1556 RX
N206627 HYDROCODONE BITARTRATE HYSINGLA TABLET, EXTENDED RELEASE ORAL 30MG 9682077 Oct 30, 2020 U-1556 RX
N206627 HYDROCODONE BITARTRATE HYSINGLA TABLET, EXTENDED RELEASE ORAL 40MG 9682077 Oct 30, 2020 U-1556 RX
N206627 HYDROCODONE BITARTRATE HYSINGLA TABLET, EXTENDED RELEASE ORAL 60MG 9682077 Oct 30, 2020 U-1556 RX
N206627 HYDROCODONE BITARTRATE HYSINGLA TABLET, EXTENDED RELEASE ORAL 80MG 9682077 Oct 30, 2020 U-1556 RX
N206627 HYDROCODONE BITARTRATE HYSINGLA TABLET, EXTENDED RELEASE ORAL 100MG 9682077 Oct 30, 2020 U-1556 RX
N206627 HYDROCODONE BITARTRATE HYSINGLA TABLET, EXTENDED RELEASE ORAL 120MG 9682077 Oct 30, 2020 U-1556 RX
N208026 LINAGLIPTIN; METFORMIN HYDROCHLORIDE JENTADUETO XR TABLET, EXTENDED RELEASE ORAL 2.5MG;1GM 8846695 Jun 4, 2030 U-1503 RX
N208079 BETAMETHASONE DIPROPIONATE SERNIVO SPRAY TOPICAL EQ 0.05% BASE/SPRAY 9655907 Aug 31, 2030 DP U-1858 RX
N208090 OXYCODONE XTAMPZA ER CAPSULE, EXTENDED RELEASE ORAL 9MG 9682075 Dec 10, 2030 DP U-1556 RX
N208090 OXYCODONE XTAMPZA ER CAPSULE, EXTENDED RELEASE ORAL 13.5MG 9682075 Dec 10, 2030 DP U-1556 RX
N208090 OXYCODONE XTAMPZA ER CAPSULE, EXTENDED RELEASE ORAL 18MG 9682075 Dec 10, 2030 DP U-1556 RX
N208090 OXYCODONE XTAMPZA ER CAPSULE, EXTENDED RELEASE ORAL 27MG 9682075 Dec 10, 2030 DP U-1556 RX
N208090 OXYCODONE XTAMPZA ER CAPSULE, EXTENDED RELEASE ORAL 36MG 9682075 Dec 10, 2030 DP U-1556 RX

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

Last Updated June 23, 2017.

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