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.
47 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
N022291 ELTROMBOPAG OLAMINE PROMACTA TABLET ORAL EQ 50MG ACID 7547719 07/13/2025 DS DP U-930 RX
N022291 ELTROMBOPAG OLAMINE PROMACTA TABLET ORAL EQ 50MG ACID 7547719 07/13/2025 DS DP U-1306 RX
N022291 ELTROMBOPAG OLAMINE PROMACTA TABLET ORAL EQ 50MG ACID 7547719 07/13/2025 DS DP U-1575 RX
N022291 ELTROMBOPAG OLAMINE PROMACTA TABLET ORAL EQ 50MG ACID 7547719 07/13/2025 DS DP U-2452 RX
N022291 ELTROMBOPAG OLAMINE PROMACTA TABLET ORAL EQ 50MG ACID 7547719 07/13/2025 DS DP U-2451 RX
N022291 ELTROMBOPAG OLAMINE PROMACTA TABLET ORAL EQ 75MG ACID 7547719 07/13/2025 DS DP U-930 RX
N022291 ELTROMBOPAG OLAMINE PROMACTA TABLET ORAL EQ 75MG ACID 7547719 07/13/2025 DS DP U-1306 RX
N022291 ELTROMBOPAG OLAMINE PROMACTA TABLET ORAL EQ 75MG ACID 7547719 07/13/2025 DS DP U-1575 RX
N022291 ELTROMBOPAG OLAMINE PROMACTA TABLET ORAL EQ 75MG ACID 7547719 07/13/2025 DS DP U-2452 RX
N022291 ELTROMBOPAG OLAMINE PROMACTA TABLET ORAL EQ 75MG ACID 7547719 07/13/2025 DS DP U-2451 RX
N022291 ELTROMBOPAG OLAMINE PROMACTA TABLET ORAL EQ 50MG ACID 7547719*PED 01/13/2026 RX
N022291 ELTROMBOPAG OLAMINE PROMACTA TABLET ORAL EQ 75MG ACID 7547719*PED 01/13/2026 RX
N022291 ELTROMBOPAG OLAMINE PROMACTA TABLET ORAL EQ 50MG ACID 7795293 05/21/2023 U-930 RX
N022291 ELTROMBOPAG OLAMINE PROMACTA TABLET ORAL EQ 50MG ACID 7795293 05/21/2023 U-1306 RX
N022291 ELTROMBOPAG OLAMINE PROMACTA TABLET ORAL EQ 50MG ACID 7795293 05/21/2023 U-2451 RX
N022291 ELTROMBOPAG OLAMINE PROMACTA TABLET ORAL EQ 75MG ACID 7795293 05/21/2023 U-930 RX
N022291 ELTROMBOPAG OLAMINE PROMACTA TABLET ORAL EQ 75MG ACID 7795293 05/21/2023 U-1306 RX
N022291 ELTROMBOPAG OLAMINE PROMACTA TABLET ORAL EQ 75MG ACID 7795293 05/21/2023 U-2451 RX
N022291 ELTROMBOPAG OLAMINE PROMACTA TABLET ORAL EQ 50MG ACID 7795293*PED 11/21/2023 RX
N022291 ELTROMBOPAG OLAMINE PROMACTA TABLET ORAL EQ 75MG ACID 7795293*PED 11/21/2023 RX
N022291 ELTROMBOPAG OLAMINE PROMACTA TABLET ORAL EQ 25MG ACID 8052993 08/01/2027 DP U-930 RX 12/07/2011
N022291 ELTROMBOPAG OLAMINE PROMACTA TABLET ORAL EQ 25MG ACID 8052993 08/01/2027 DP U-1306 RX 12/07/2011
N022291 ELTROMBOPAG OLAMINE PROMACTA TABLET ORAL EQ 25MG ACID 8052993 08/01/2027 DP U-1575 RX 12/07/2011
N022291 ELTROMBOPAG OLAMINE PROMACTA TABLET ORAL EQ 25MG ACID 8052993 08/01/2027 DP U-2451 RX 12/07/2011
N022291 ELTROMBOPAG OLAMINE PROMACTA TABLET ORAL EQ 25MG ACID 8052993*PED 02/01/2028 RX
N022291 ELTROMBOPAG OLAMINE PROMACTA TABLET ORAL EQ 50MG ACID 8052994 08/01/2027 DP U-930 RX 12/07/2011
N022291 ELTROMBOPAG OLAMINE PROMACTA TABLET ORAL EQ 50MG ACID 8052994 08/01/2027 DP U-1306 RX 12/07/2011
N022291 ELTROMBOPAG OLAMINE PROMACTA TABLET ORAL EQ 50MG ACID 8052994 08/01/2027 DP U-2451 RX 12/07/2011
N022291 ELTROMBOPAG OLAMINE PROMACTA TABLET ORAL EQ 50MG ACID 8052994*PED 02/01/2028 RX
N022291 ELTROMBOPAG OLAMINE PROMACTA TABLET ORAL EQ 75MG ACID 8062665 08/01/2027 DP U-930 RX 12/07/2011
N022291 ELTROMBOPAG OLAMINE PROMACTA TABLET ORAL EQ 75MG ACID 8062665 08/01/2027 DP U-1306 RX 12/07/2011
N022291 ELTROMBOPAG OLAMINE PROMACTA TABLET ORAL EQ 75MG ACID 8062665 08/01/2027 DP U-2451 RX 12/07/2011
N022291 ELTROMBOPAG OLAMINE PROMACTA TABLET ORAL EQ 75MG ACID 8062665*PED 02/01/2028 RX
N022291 ELTROMBOPAG OLAMINE PROMACTA TABLET ORAL EQ 12.5MG ACID 8071129 08/01/2027 DP U-930 RX 12/21/2011
N022291 ELTROMBOPAG OLAMINE PROMACTA TABLET ORAL EQ 12.5MG ACID 8071129 08/01/2027 DP U-1306 RX 12/21/2011
N022291 ELTROMBOPAG OLAMINE PROMACTA TABLET ORAL EQ 12.5MG ACID 8071129 08/01/2027 DP U-2451 RX 12/21/2011
N022291 ELTROMBOPAG OLAMINE PROMACTA TABLET ORAL EQ 12.5MG ACID 8071129*PED 02/01/2028 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 10201542 10/18/2033 DP U-1753 RX 03/14/2019
N208624 DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR VIEKIRA XR TABLET, EXTENDED RELEASE ORAL EQ 200MG BASE;8.33MG;50MG;33.33MG 10201541 05/17/2032 DP RX 03/14/2019
N208624 DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR VIEKIRA XR TABLET, EXTENDED RELEASE ORAL EQ 200MG BASE;8.33MG;50MG;33.33MG 10201584 05/17/2032 U-1889 RX 03/14/2019
N209410 AMANTADINE HYDROCHLORIDE OSMOLEX ER TABLET, EXTENDED RELEASE ORAL EQ 129MG BASE 10213393 02/15/2038 U-20 RX 03/13/2019
N209410 AMANTADINE HYDROCHLORIDE OSMOLEX ER TABLET, EXTENDED RELEASE ORAL EQ 193MG BASE 10213393 02/15/2038 U-20 RX 03/13/2019
N209410 AMANTADINE HYDROCHLORIDE OSMOLEX ER TABLET, EXTENDED RELEASE ORAL EQ 258MG BASE 10213393 02/15/2038 U-20 RX 03/13/2019
N209410 AMANTADINE HYDROCHLORIDE OSMOLEX ER TABLET, EXTENDED RELEASE ORAL EQ 129MG BASE 10213394 02/15/2038 U-2497 RX 03/13/2019
N209410 AMANTADINE HYDROCHLORIDE OSMOLEX ER TABLET, EXTENDED RELEASE ORAL EQ 193MG BASE 10213394 02/15/2038 U-2497 RX 03/13/2019
N209410 AMANTADINE HYDROCHLORIDE OSMOLEX ER TABLET, EXTENDED RELEASE ORAL EQ 258MG BASE 10213394 02/15/2038 U-2497 RX 03/13/2019
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

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Last Updated March 22, 2019.

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