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.
49 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
N020986 INSULIN ASPART RECOMBINANT NOVOLOG FLEXTOUCH INJECTABLE SUBCUTANEOUS 300 UNITS/3ML (100 UNITS/ML) 10376652 01/20/2026 DP DISCN 09/13/2019
N021148 SOMATROPIN NORDITROPIN FLEXPRO INJECTABLE INJECTION 5MG/1.5ML 10376652 01/20/2026 DP RX 09/13/2019
N021148 SOMATROPIN NORDITROPIN FLEXPRO INJECTABLE INJECTION 10MG/1.5ML 10376652 01/20/2026 DP RX 09/13/2019
N021148 SOMATROPIN NORDITROPIN FLEXPRO INJECTABLE INJECTION 15MG/1.5ML 10376652 01/20/2026 DP RX 09/13/2019
N021148 SOMATROPIN NORDITROPIN FLEXPRO INJECTABLE INJECTION 30MG/3ML 10376652 01/20/2026 DP RX 09/13/2019
N021536 INSULIN DETEMIR RECOMBINANT LEVEMIR FLEXTOUCH INJECTABLE SUBCUTANEOUS 300 UNITS/3ML (100 UNITS/ML) 10376652 01/20/2026 DP RX 09/13/2019
N022527 FINGOLIMOD HYDROCHLORIDE GILENYA CAPSULE ORAL EQ 0.5MG BASE 9187405 06/25/2027 U-2613 RX 12/02/2015
N022527 FINGOLIMOD HYDROCHLORIDE GILENYA CAPSULE ORAL EQ 0.5MG BASE 9187405*PED 12/25/2027 RX
N202379 ABIRATERONE ACETATE ZYTIGA TABLET ORAL 250MG 8822438 08/24/2027 U-1579 Y RX 10/01/2014
N202379 ABIRATERONE ACETATE ZYTIGA TABLET ORAL 250MG 8822438 08/24/2027 U-1580 Y RX 10/01/2014
N202379 ABIRATERONE ACETATE ZYTIGA TABLET ORAL 250MG 8822438 08/24/2027 U-2235 Y RX 10/01/2014
N202379 ABIRATERONE ACETATE ZYTIGA TABLET ORAL 500MG 8822438 08/24/2027 U-1579 Y RX 08/02/2017
N202379 ABIRATERONE ACETATE ZYTIGA TABLET ORAL 500MG 8822438 08/24/2027 U-1580 Y RX 08/02/2017
N202379 ABIRATERONE ACETATE ZYTIGA TABLET ORAL 500MG 8822438 08/24/2027 U-2235 Y RX 08/02/2017
N203313 INSULIN ASPART; INSULIN DEGLUDEC RYZODEG 70/30 SOLUTION SUBCUTANEOUS 90 UNITS/3ML;210 UNITS/3ML (30 UNITS/ML;70 UNITS/ML) 10376652 01/20/2026 DP DISCN 09/13/2019
N203314 INSULIN DEGLUDEC TRESIBA SOLUTION SUBCUTANEOUS 300 UNITS/3ML (100 UNITS/ML) 10376652 01/20/2026 DP RX 09/13/2019
N203314 INSULIN DEGLUDEC TRESIBA SOLUTION SUBCUTANEOUS 600 UNITS/3ML (200 UNITS/ML) 10376652 01/20/2026 DP RX 09/13/2019
N203314 INSULIN DEGLUDEC TRESIBA SOLUTION SUBCUTANEOUS 1000 UNITS/10ML (100 UNITS/ML) 10376652 01/20/2026 DP RX 09/13/2019
N205832 NINTEDANIB ESYLATE OFEV CAPSULE ORAL EQ 100MG BASE 10154990 12/20/2025 U-2620 RX 09/18/2019
N205832 NINTEDANIB ESYLATE OFEV CAPSULE ORAL EQ 150MG BASE 10154990 12/20/2025 U-2620 RX 09/18/2019
N206321 LIRAGLUTIDE RECOMBINANT SAXENDA SOLUTION SUBCUTANEOUS 18MG/3ML (6MG/ML) 10376652 01/20/2026 DP RX 09/13/2019
N208583 INSULIN DEGLUDEC; LIRAGLUTIDE XULTOPHY 100/3.6 SOLUTION SUBCUTANEOUS 300 UNITS/3ML;10.8MG/3ML (100 UNITS/ML;3.6MG/ML) 10376652 01/20/2026 DP RX 09/13/2019
N208751 INSULIN ASPART FIASP FLEXTOUCH SOLUTION SUBCUTANEOUS 300 UNITS/3ML (100 UNITS/ML) 10376652 01/20/2026 DP RX 09/13/2019
N209637 SEMAGLUTIDE OZEMPIC SOLUTION SUBCUTANEOUS 2MG/1.5ML (1.34MG/ML) 10376652 01/20/2026 DP RX 09/13/2019
N209936 COPANLISIB DIHYDROCHLORIDE ALIQOPA POWDER INTRAVENOUS 60MG/VIAL 10383876 03/29/2032 DS DP RX 09/18/2019
N210632 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM SOLUTION INTRAVENOUS 100MCG/5ML (20MCG/ML) 10398669 12/01/2036 DP RX 09/13/2019
N210632 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM SOLUTION INTRAVENOUS 200MCG/5ML (40MCG/ML) 10398669 12/01/2036 DP RX 09/13/2019
N210632 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM SOLUTION INTRAVENOUS 500MCG/5ML (100MCG/ML) 10398669 12/01/2036 DP RX 09/13/2019
N211150 PITOLISANT HYDROCHLORIDE WAKIX TABLET ORAL EQ 4.45MG BASE 7169928 02/02/2020 DS DP RX 09/11/2019
N211150 PITOLISANT HYDROCHLORIDE WAKIX TABLET ORAL EQ 17.8MG BASE 7169928 02/02/2020 DS DP RX 09/11/2019
N211150 PITOLISANT HYDROCHLORIDE WAKIX TABLET ORAL EQ 4.45MG BASE 7910605 09/23/2022 U-1101 RX 09/11/2019
N211150 PITOLISANT HYDROCHLORIDE WAKIX TABLET ORAL EQ 17.8MG BASE 7910605 09/23/2022 U-1101 RX 09/11/2019
N211150 PITOLISANT HYDROCHLORIDE WAKIX TABLET ORAL EQ 4.45MG BASE 8207197 02/25/2029 DS DP RX 09/11/2019
N211150 PITOLISANT HYDROCHLORIDE WAKIX TABLET ORAL EQ 17.8MG BASE 8207197 02/25/2029 DS DP RX 09/11/2019
N211150 PITOLISANT HYDROCHLORIDE WAKIX TABLET ORAL EQ 4.45MG BASE 8354430 02/26/2026 U-1101 RX 09/11/2019
N211150 PITOLISANT HYDROCHLORIDE WAKIX TABLET ORAL EQ 17.8MG BASE 8354430 02/26/2026 U-1101 RX 09/11/2019
N211150 PITOLISANT HYDROCHLORIDE WAKIX TABLET ORAL EQ 4.45MG BASE 8486947 09/26/2029 U-1101 RX 09/11/2019
N211150 PITOLISANT HYDROCHLORIDE WAKIX TABLET ORAL EQ 17.8MG BASE 8486947 09/26/2029 U-1101 RX 09/11/2019
N211672 LEFAMULIN ACETATE XENLETA TABLET ORAL EQ 600MG BASE 6753445 07/09/2021 DS DP U-2619 RX 09/17/2019
N211672 LEFAMULIN ACETATE XENLETA TABLET ORAL EQ 600MG BASE 8071643 01/16/2029 DS DP RX 09/17/2019
N211672 LEFAMULIN ACETATE XENLETA TABLET ORAL EQ 600MG BASE 8153689 03/19/2028 DS DP RX 09/17/2019
N211672 LEFAMULIN ACETATE XENLETA TABLET ORAL EQ 600MG BASE 9120727 05/23/2031 DS DP RX 09/17/2019
N211673 LEFAMULIN ACETATE XENLETA SOLUTION INTRAVENOUS EQ 150MG BASE/15ML (EQ 10MG BASE/ML) 6753445 07/09/2021 DS DP U-2619 RX 09/17/2019
N211673 LEFAMULIN ACETATE XENLETA SOLUTION INTRAVENOUS EQ 150MG BASE/15ML (EQ 10MG BASE/ML) 8071643 01/16/2029 DS DP RX 09/17/2019
N211673 LEFAMULIN ACETATE XENLETA SOLUTION INTRAVENOUS EQ 150MG BASE/15ML (EQ 10MG BASE/ML) 8153689 03/19/2028 DS DP RX 09/17/2019
N211675 UPADACITINIB RINVOQ TABLET, EXTENDED RELEASE ORAL EQ 15MG BASE 8962629 01/15/2031 DS U-2616 RX 09/13/2019
N211675 UPADACITINIB RINVOQ TABLET, EXTENDED RELEASE ORAL EQ 15MG BASE 9951080 10/17/2036 DS DP RX 09/13/2019
N211675 UPADACITINIB RINVOQ TABLET, EXTENDED RELEASE ORAL EQ 15MG BASE 9963459 10/17/2036 DP RX 09/13/2019
N211675 UPADACITINIB RINVOQ TABLET, EXTENDED RELEASE ORAL EQ 15MG BASE RE47221 12/01/2030 DS RX 09/13/2019

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

Last Updated September 19, 2019.

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