Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
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.
| 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 |
| N215727 | COLCHICINE | LODOCO | TABLET | ORAL | 0.5MG | 10130585 | 05/09/2034 | U-3642 | RX | 06/29/2023 | |||
| N215192 | VADADUSTAT | VAFSEO | TABLET | ORAL | 150MG | 10149842 | 11/14/2034 | DS | DP | RX | 04/10/2024 | ||
| N215192 | VADADUSTAT | VAFSEO | TABLET | ORAL | 450MG | 10149842 | 11/14/2034 | DS | DP | RX | 04/10/2024 | ||
| N215192 | VADADUSTAT | VAFSEO | TABLET | ORAL | 300MG | 10149842 | 11/14/2034 | DS | DP | RX | 04/10/2024 | ||
| N215727 | COLCHICINE | LODOCO | TABLET | ORAL | 0.5MG | 10206891 | 11/01/2033 | U-3641 | RX | 06/29/2023 | |||
| N215727 | COLCHICINE | LODOCO | TABLET | ORAL | 0.5MG | 10265281 | 11/01/2033 | U-3639 | RX | 06/29/2023 | |||
| N212489 | OPICAPONE | ONGENTYS | CAPSULE | ORAL | 25MG | 10357468 | 05/27/2035 | U-2812 | Y | RX | 05/19/2020 | ||
| N212489 | OPICAPONE | ONGENTYS | CAPSULE | ORAL | 50MG | 10357468 | 05/27/2035 | U-2812 | Y | RX | 05/19/2020 | ||
| N213217 | ZANUBRUTINIB | BRUKINSA | CAPSULE | ORAL | 80MG | 10570139 | 04/22/2034 | U-1745 | RX | 06/04/2021 | |||
| N213217 | ZANUBRUTINIB | BRUKINSA | CAPSULE | ORAL | 80MG | 10570139 | 04/22/2034 | U-3063 | RX | 06/04/2021 | |||
| N213217 | ZANUBRUTINIB | BRUKINSA | CAPSULE | ORAL | 80MG | 10570139 | 04/22/2034 | U-2666 | RX | 06/04/2021 | |||
| N213217 | ZANUBRUTINIB | BRUKINSA | CAPSULE | ORAL | 80MG | 10570139 | 04/22/2034 | U-2537 | RX | 06/04/2021 | |||
| N213217 | ZANUBRUTINIB | BRUKINSA | CAPSULE | ORAL | 80MG | 10570139 | 04/22/2034 | U-2145 | RX | 06/04/2021 | |||
| N213217 | ZANUBRUTINIB | BRUKINSA | CAPSULE | ORAL | 80MG | 10570139 | 04/22/2034 | U-3860 | RX | 06/04/2021 | |||
| N213217 | ZANUBRUTINIB | BRUKINSA | CAPSULE | ORAL | 80MG | 10570139 | 04/22/2034 | U-3486 | RX | 06/04/2021 | |||
| N217677 | NIROGACESTAT HYDROBROMIDE | OGSIVEO | TABLET | ORAL | EQ 100MG BASE | 10590087 | 08/09/2039 | DS | RX | 04/12/2024 | |||
| N217677 | NIROGACESTAT HYDROBROMIDE | OGSIVEO | TABLET | ORAL | EQ 150MG BASE | 10590087 | 08/09/2039 | DS | RX | 04/12/2024 | |||
| N217865 | GIVINOSTAT HYDROCHLORIDE | DUVYZAT | SUSPENSION | ORAL | EQ 8.86MG BASE/ML | 10688047 | 10/28/2036 | DP | U-3885 | RX | 04/19/2024 | ||
| N217677 | NIROGACESTAT HYDROBROMIDE | OGSIVEO | TABLET | ORAL | EQ 100MG BASE | 10710966 | 08/09/2039 | DS | U-3754 | RX | 04/12/2024 | ||
| N217677 | NIROGACESTAT HYDROBROMIDE | OGSIVEO | TABLET | ORAL | EQ 150MG BASE | 10710966 | 08/09/2039 | DS | U-3754 | RX | 04/12/2024 | ||
| N215727 | COLCHICINE | LODOCO | TABLET | ORAL | 0.5MG | 10842762 | 11/01/2033 | U-3640 | RX | 06/29/2023 | |||
| N211617 | BEMPEDOIC ACID; EZETIMIBE | NEXLIZET | TABLET | ORAL | 180MG;10MG | 10912751 | 03/14/2036 | U-3884 | RX | 10/14/2021 | |||
| N211617 | BEMPEDOIC ACID; EZETIMIBE | NEXLIZET | TABLET | ORAL | 180MG;10MG | 10912751 | 03/14/2036 | U-3224 | RX | 10/14/2021 | |||
| N217686 | APROCITENTAN | TRYVIO | TABLET | ORAL | 12.5MG | 10919881 | 02/26/2038 | DS | DP | RX | 04/16/2024 | ||
| N217677 | NIROGACESTAT HYDROBROMIDE | OGSIVEO | TABLET | ORAL | EQ 100MG BASE | 10941118 | 08/09/2039 | DS | U-3754 | RX | 04/12/2024 | ||
| N217677 | NIROGACESTAT HYDROBROMIDE | OGSIVEO | TABLET | ORAL | EQ 150MG BASE | 10941118 | 08/09/2039 | DS | U-3754 | RX | 04/12/2024 | ||
| N218490 | MACITENTAN; TADALAFIL | OPSYNVI | TABLET | ORAL | 10MG;20MG | 10946015 | 09/11/2026 | DP | U-3881 | RX | 04/18/2024 | ||
| N218490 | MACITENTAN; TADALAFIL | OPSYNVI | TABLET | ORAL | 10MG;40MG | 10946015 | 09/11/2026 | DP | U-3881 | RX | 04/18/2024 | ||
| N215727 | COLCHICINE | LODOCO | TABLET | ORAL | 0.5MG | 11026899 | 11/01/2033 | U-3639 | RX | 06/29/2023 | |||
| N215727 | COLCHICINE | LODOCO | TABLET | ORAL | 0.5MG | 11026900 | 11/01/2033 | U-3639 | RX | 06/29/2023 | |||
| N215727 | COLCHICINE | LODOCO | TABLET | ORAL | 0.5MG | 11026901 | 11/01/2033 | U-3638 | RX | 06/29/2023 | |||
| N215192 | VADADUSTAT | VAFSEO | TABLET | ORAL | 150MG | 11065237 | 11/14/2034 | DS | DP | U-3876 | RX | 04/10/2024 | |
| N215192 | VADADUSTAT | VAFSEO | TABLET | ORAL | 450MG | 11065237 | 11/14/2034 | DS | DP | U-3876 | RX | 04/10/2024 | |
| N215192 | VADADUSTAT | VAFSEO | TABLET | ORAL | 300MG | 11065237 | 11/14/2034 | DS | DP | U-3876 | RX | 04/10/2024 | |
| N213217 | ZANUBRUTINIB | BRUKINSA | CAPSULE | ORAL | 80MG | 11142528 | 04/22/2034 | DP | U-1745 | RX | 11/12/2021 | ||
| N213217 | ZANUBRUTINIB | BRUKINSA | CAPSULE | ORAL | 80MG | 11142528 | 04/22/2034 | DP | U-3063 | RX | 11/12/2021 | ||
| N213217 | ZANUBRUTINIB | BRUKINSA | CAPSULE | ORAL | 80MG | 11142528 | 04/22/2034 | DP | U-2666 | RX | 11/12/2021 | ||
| N213217 | ZANUBRUTINIB | BRUKINSA | CAPSULE | ORAL | 80MG | 11142528 | 04/22/2034 | DP | U-2537 | RX | 11/12/2021 | ||
| N213217 | ZANUBRUTINIB | BRUKINSA | CAPSULE | ORAL | 80MG | 11142528 | 04/22/2034 | DP | U-2145 | RX | 11/12/2021 | ||
| N213217 | ZANUBRUTINIB | BRUKINSA | CAPSULE | ORAL | 80MG | 11142528 | 04/22/2034 | DP | U-3860 | RX | 11/12/2021 | ||
| N213217 | ZANUBRUTINIB | BRUKINSA | CAPSULE | ORAL | 80MG | 11142528 | 04/22/2034 | DP | U-3486 | RX | 11/12/2021 | ||
| N217686 | APROCITENTAN | TRYVIO | TABLET | ORAL | 12.5MG | 11174247 | 11/06/2037 | U-3879 | RX | 04/16/2024 | |||
| N215192 | VADADUSTAT | VAFSEO | TABLET | ORAL | 150MG | 11324734 | 03/31/2036 | DP | RX | 04/10/2024 | |||
| N215192 | VADADUSTAT | VAFSEO | TABLET | ORAL | 450MG | 11324734 | 03/31/2036 | DP | RX | 04/10/2024 | |||
| N215192 | VADADUSTAT | VAFSEO | TABLET | ORAL | 300MG | 11324734 | 03/31/2036 | DP | RX | 04/10/2024 | |||
| N217806 | TIRZEPATIDE | ZEPBOUND | SOLUTION | SUBCUTANEOUS | 2.5MG/0.5ML (2.5MG/0.5ML) | 11357820 | 06/14/2039 | DP | RX | 04/18/2024 | |||
| N217806 | TIRZEPATIDE | ZEPBOUND | SOLUTION | SUBCUTANEOUS | 5MG/0.5ML (5MG/0.5ML) | 11357820 | 06/14/2039 | DP | RX | 04/18/2024 | |||
| N217806 | TIRZEPATIDE | ZEPBOUND | SOLUTION | SUBCUTANEOUS | 7.5MG/0.5ML (7.5MG/0.5ML) | 11357820 | 06/14/2039 | DP | RX | 04/18/2024 | |||
| N217806 | TIRZEPATIDE | ZEPBOUND | SOLUTION | SUBCUTANEOUS | 12.5MG/0.5ML (12.5MG/0.5ML) | 11357820 | 06/14/2039 | DP | RX | 04/18/2024 | |||
| N217806 | TIRZEPATIDE | ZEPBOUND | SOLUTION | SUBCUTANEOUS | 10MG/0.5ML (10MG/0.5ML) | 11357820 | 06/14/2039 | DP | RX | 04/18/2024 | |||
| N217806 | TIRZEPATIDE | ZEPBOUND | SOLUTION | SUBCUTANEOUS | 15MG/0.5ML (15MG/0.5ML) | 11357820 | 06/14/2039 | DP | RX | 04/18/2024 | |||
| N217677 | NIROGACESTAT HYDROBROMIDE | OGSIVEO | TABLET | ORAL | EQ 100MG BASE | 11504354 | 07/08/2042 | DP | RX | 04/12/2024 | |||
| N217677 | NIROGACESTAT HYDROBROMIDE | OGSIVEO | TABLET | ORAL | EQ 150MG BASE | 11504354 | 07/08/2042 | DP | RX | 04/12/2024 | |||
| N217677 | NIROGACESTAT HYDROBROMIDE | OGSIVEO | TABLET | ORAL | EQ 100MG BASE | 11612588 | 07/08/2042 | DP | U-3754 | RX | 04/12/2024 | ||
| N217677 | NIROGACESTAT HYDROBROMIDE | OGSIVEO | TABLET | ORAL | EQ 150MG BASE | 11612588 | 07/08/2042 | DP | U-3754 | RX | 04/12/2024 | ||
| N217686 | APROCITENTAN | TRYVIO | TABLET | ORAL | 12.5MG | 11680058 | 07/26/2038 | U-3878 | RX | 04/16/2024 | |||
| N211616 | BEMPEDOIC ACID | NEXLETOL | TABLET | ORAL | 180MG | 11744816 | 03/14/2036 | U-3883 | RX | 04/19/2024 | |||
| N211617 | BEMPEDOIC ACID; EZETIMIBE | NEXLIZET | TABLET | ORAL | 180MG;10MG | 11744816 | 03/14/2036 | U-3883 | RX | 10/03/2023 | |||
| N211617 | BEMPEDOIC ACID; EZETIMIBE | NEXLIZET | TABLET | ORAL | 180MG;10MG | 11744816 | 03/14/2036 | U-3692 | RX | 10/03/2023 | |||
| N213217 | ZANUBRUTINIB | BRUKINSA | CAPSULE | ORAL | 80MG | 11786531 | 01/19/2043 | U-3715 | RX | 11/02/2023 | |||
| N213217 | ZANUBRUTINIB | BRUKINSA | CAPSULE | ORAL | 80MG | 11786531 | 01/19/2043 | U-3720 | RX | 11/02/2023 | |||
| N213217 | ZANUBRUTINIB | BRUKINSA | CAPSULE | ORAL | 80MG | 11786531 | 01/19/2043 | U-3719 | RX | 11/02/2023 | |||
| N213217 | ZANUBRUTINIB | BRUKINSA | CAPSULE | ORAL | 80MG | 11786531 | 01/19/2043 | U-3875 | RX | 11/02/2023 | |||
| N213217 | ZANUBRUTINIB | BRUKINSA | CAPSULE | ORAL | 80MG | 11786531 | 01/19/2043 | U-3718 | RX | 11/02/2023 | |||
| N213217 | ZANUBRUTINIB | BRUKINSA | CAPSULE | ORAL | 80MG | 11786531 | 01/19/2043 | U-3717 | RX | 11/02/2023 | |||
| N213217 | ZANUBRUTINIB | BRUKINSA | CAPSULE | ORAL | 80MG | 11786531 | 01/19/2043 | U-3716 | RX | 11/02/2023 | |||
| N217686 | APROCITENTAN | TRYVIO | TABLET | ORAL | 12.5MG | 11787782 | 03/02/2038 | U-3877 | RX | 04/16/2024 | |||
| N217677 | NIROGACESTAT HYDROBROMIDE | OGSIVEO | TABLET | ORAL | EQ 100MG BASE | 11807611 | 09/08/2042 | DP | U-3754 | RX | 04/12/2024 | ||
| N217677 | NIROGACESTAT HYDROBROMIDE | OGSIVEO | TABLET | ORAL | EQ 150MG BASE | 11807611 | 09/08/2042 | DP | U-3754 | RX | 04/12/2024 | ||
| N217677 | NIROGACESTAT HYDROBROMIDE | OGSIVEO | TABLET | ORAL | EQ 100MG BASE | 11820748 | 08/09/2039 | DP | RX | 04/12/2024 | |||
| N217677 | NIROGACESTAT HYDROBROMIDE | OGSIVEO | TABLET | ORAL | EQ 150MG BASE | 11820748 | 08/09/2039 | DP | RX | 04/12/2024 | |||
| N215192 | VADADUSTAT | VAFSEO | TABLET | ORAL | 150MG | 11844756 | 03/31/2036 | U-3876 | RX | 04/10/2024 | |||
| N215192 | VADADUSTAT | VAFSEO | TABLET | ORAL | 450MG | 11844756 | 03/31/2036 | U-3876 | RX | 04/10/2024 | |||
| N215192 | VADADUSTAT | VAFSEO | TABLET | ORAL | 300MG | 11844756 | 03/31/2036 | U-3876 | RX | 04/10/2024 | |||
| N217677 | NIROGACESTAT HYDROBROMIDE | OGSIVEO | TABLET | ORAL | EQ 100MG BASE | 11844780 | 09/08/2042 | DP | U-3754 | RX | 04/12/2024 | ||
| N217677 | NIROGACESTAT HYDROBROMIDE | OGSIVEO | TABLET | ORAL | EQ 150MG BASE | 11844780 | 09/08/2042 | DP | U-3754 | RX | 04/12/2024 | ||
| N217677 | NIROGACESTAT HYDROBROMIDE | OGSIVEO | TABLET | ORAL | EQ 100MG BASE | 11845732 | 08/09/2039 | DS | U-3754 | RX | 04/12/2024 | ||
| N217677 | NIROGACESTAT HYDROBROMIDE | OGSIVEO | TABLET | ORAL | EQ 150MG BASE | 11845732 | 08/09/2039 | DS | U-3754 | RX | 04/12/2024 | ||
| N215192 | VADADUSTAT | VAFSEO | TABLET | ORAL | 150MG | 11857543 | 06/09/2034 | U-3876 | RX | 04/10/2024 | |||
| N215192 | VADADUSTAT | VAFSEO | TABLET | ORAL | 450MG | 11857543 | 06/09/2034 | U-3876 | RX | 04/10/2024 | |||
| N215192 | VADADUSTAT | VAFSEO | TABLET | ORAL | 300MG | 11857543 | 06/09/2034 | U-3876 | RX | 04/10/2024 | |||
| N217677 | NIROGACESTAT HYDROBROMIDE | OGSIVEO | TABLET | ORAL | EQ 100MG BASE | 11872211 | 05/19/2043 | U-3754 | RX | 04/12/2024 | |||
| N217677 | NIROGACESTAT HYDROBROMIDE | OGSIVEO | TABLET | ORAL | EQ 150MG BASE | 11872211 | 05/19/2043 | U-3754 | RX | 04/12/2024 | |||
| N217677 | NIROGACESTAT HYDROBROMIDE | OGSIVEO | TABLET | ORAL | EQ 100MG BASE | 11884634 | 08/09/2039 | DP | RX | 04/12/2024 | |||
| N217677 | NIROGACESTAT HYDROBROMIDE | OGSIVEO | TABLET | ORAL | EQ 150MG BASE | 11884634 | 08/09/2039 | DP | RX | 04/12/2024 | |||
| N217677 | NIROGACESTAT HYDROBROMIDE | OGSIVEO | TABLET | ORAL | EQ 100MG BASE | 11884635 | 08/09/2039 | DP | RX | 04/12/2024 | |||
| N217677 | NIROGACESTAT HYDROBROMIDE | OGSIVEO | TABLET | ORAL | EQ 150MG BASE | 11884635 | 08/09/2039 | DP | RX | 04/12/2024 | |||
| N213217 | ZANUBRUTINIB | BRUKINSA | CAPSULE | ORAL | 80MG | 11896596 | 01/19/2043 | U-3715 | RX | 03/12/2024 | |||
| N213217 | ZANUBRUTINIB | BRUKINSA | CAPSULE | ORAL | 80MG | 11896596 | 01/19/2043 | U-3720 | RX | 03/12/2024 | |||
| N213217 | ZANUBRUTINIB | BRUKINSA | CAPSULE | ORAL | 80MG | 11896596 | 01/19/2043 | U-3719 | RX | 03/12/2024 | |||
| N213217 | ZANUBRUTINIB | BRUKINSA | CAPSULE | ORAL | 80MG | 11896596 | 01/19/2043 | U-3875 | RX | 03/12/2024 | |||
| N213217 | ZANUBRUTINIB | BRUKINSA | CAPSULE | ORAL | 80MG | 11896596 | 01/19/2043 | U-3718 | RX | 03/12/2024 | |||
| N213217 | ZANUBRUTINIB | BRUKINSA | CAPSULE | ORAL | 80MG | 11896596 | 01/19/2043 | U-3717 | RX | 03/12/2024 | |||
| N213217 | ZANUBRUTINIB | BRUKINSA | CAPSULE | ORAL | 80MG | 11896596 | 01/19/2043 | U-3716 | RX | 03/12/2024 | |||
| N217677 | NIROGACESTAT HYDROBROMIDE | OGSIVEO | TABLET | ORAL | EQ 100MG BASE | 11905255 | 08/09/2039 | DP | RX | 04/12/2024 | |||
| N217677 | NIROGACESTAT HYDROBROMIDE | OGSIVEO | TABLET | ORAL | EQ 150MG BASE | 11905255 | 08/09/2039 | DP | RX | 04/12/2024 | |||
| N213217 | ZANUBRUTINIB | BRUKINSA | CAPSULE | ORAL | 80MG | 11911386 | 01/19/2043 | U-3715 | RX | 02/28/2024 | |||
| N213217 | ZANUBRUTINIB | BRUKINSA | CAPSULE | ORAL | 80MG | 11911386 | 01/19/2043 | U-3720 | RX | 02/28/2024 | |||
| N213217 | ZANUBRUTINIB | BRUKINSA | CAPSULE | ORAL | 80MG | 11911386 | 01/19/2043 | U-3719 | RX | 02/28/2024 | |||
| N213217 | ZANUBRUTINIB | BRUKINSA | CAPSULE | ORAL | 80MG | 11911386 | 01/19/2043 | U-3875 | RX | 02/28/2024 | |||
| N213217 | ZANUBRUTINIB | BRUKINSA | CAPSULE | ORAL | 80MG | 11911386 | 01/19/2043 | U-3718 | RX | 02/28/2024 | |||
| N213217 | ZANUBRUTINIB | BRUKINSA | CAPSULE | ORAL | 80MG | 11911386 | 01/19/2043 | U-3717 | RX | 02/28/2024 | |||
| N213217 | ZANUBRUTINIB | BRUKINSA | CAPSULE | ORAL | 80MG | 11911386 | 01/19/2043 | U-3716 | RX | 02/28/2024 | |||
| N217806 | TIRZEPATIDE | ZEPBOUND | SOLUTION | SUBCUTANEOUS | 2.5MG/0.5ML (2.5MG/0.5ML) | 11918623 | 06/14/2039 | U-3855 | RX | 04/18/2024 | |||
| N217806 | TIRZEPATIDE | ZEPBOUND | SOLUTION | SUBCUTANEOUS | 5MG/0.5ML (5MG/0.5ML) | 11918623 | 06/14/2039 | U-3855 | RX | 04/18/2024 | |||
| N217806 | TIRZEPATIDE | ZEPBOUND | SOLUTION | SUBCUTANEOUS | 7.5MG/0.5ML (7.5MG/0.5ML) | 11918623 | 06/14/2039 | U-3855 | RX | 04/18/2024 | |||
| N217806 | TIRZEPATIDE | ZEPBOUND | SOLUTION | SUBCUTANEOUS | 12.5MG/0.5ML (12.5MG/0.5ML) | 11918623 | 06/14/2039 | U-3855 | RX | 04/18/2024 | |||
| N217806 | TIRZEPATIDE | ZEPBOUND | SOLUTION | SUBCUTANEOUS | 10MG/0.5ML (10MG/0.5ML) | 11918623 | 06/14/2039 | U-3855 | RX | 04/18/2024 | |||
| N217806 | TIRZEPATIDE | ZEPBOUND | SOLUTION | SUBCUTANEOUS | 15MG/0.5ML (15MG/0.5ML) | 11918623 | 06/14/2039 | U-3855 | RX | 04/18/2024 | |||
| N217677 | NIROGACESTAT HYDROBROMIDE | OGSIVEO | TABLET | ORAL | EQ 100MG BASE | 11925619 | 05/19/2043 | U-3754 | RX | 04/12/2024 | |||
| N217677 | NIROGACESTAT HYDROBROMIDE | OGSIVEO | TABLET | ORAL | EQ 150MG BASE | 11925619 | 05/19/2043 | U-3754 | RX | 04/12/2024 | |||
| N217677 | NIROGACESTAT HYDROBROMIDE | OGSIVEO | TABLET | ORAL | EQ 100MG BASE | 11925620 | 05/19/2043 | U-3754 | RX | 04/12/2024 | |||
| N217677 | NIROGACESTAT HYDROBROMIDE | OGSIVEO | TABLET | ORAL | EQ 150MG BASE | 11925620 | 05/19/2043 | U-3754 | RX | 04/12/2024 | |||
| N211765 | UBROGEPANT | UBRELVY | TABLET | ORAL | 100MG | 11925709 | 01/30/2035 | DP | RX | 04/10/2024 | |||
| N211765 | UBROGEPANT | UBRELVY | TABLET | ORAL | 50MG | 11925709 | 01/30/2035 | DP | RX | 04/10/2024 | |||
| N021343 | LEUPROLIDE ACETATE | ELIGARD KIT | POWDER | SUBCUTANEOUS | 7.5MG | 11931559 | 12/22/2041 | DS | RX | 04/15/2024 | |||
| N021379 | LEUPROLIDE ACETATE | ELIGARD KIT | POWDER | SUBCUTANEOUS | 22.5MG | 11931559 | 12/22/2041 | DS | RX | 04/15/2024 | |||
| N021488 | LEUPROLIDE ACETATE | ELIGARD KIT | POWDER | SUBCUTANEOUS | 30MG | 11931559 | 12/22/2041 | DS | RX | 04/15/2024 | |||
| N021731 | LEUPROLIDE ACETATE | ELIGARD KIT | POWDER | SUBCUTANEOUS | 45MG | 11931559 | 12/22/2041 | DS | RX | 04/15/2024 | |||
| N213150 | LEUPROLIDE ACETATE | FENSOLVI KIT | POWDER | SUBCUTANEOUS | 45MG | 11931559 | 12/22/2041 | DS | RX | 04/15/2024 | |||
| N217677 | NIROGACESTAT HYDROBROMIDE | OGSIVEO | TABLET | ORAL | EQ 100MG BASE | 11938116 | 05/19/2043 | U-3754 | RX | 04/12/2024 | |||
| N217677 | NIROGACESTAT HYDROBROMIDE | OGSIVEO | TABLET | ORAL | EQ 150MG BASE | 11938116 | 05/19/2043 | U-3754 | RX | 04/12/2024 | |||
| N211349 | GILTERITINIB FUMARATE | XOSPATA | TABLET | ORAL | EQ 40MG BASE | 11938130 | 07/01/2036 | DP | RX | 04/25/2024 | |||
| N211349 | GILTERITINIB FUMARATE | XOSPATA | TABLET | ORAL | EQ 40MG BASE | 11938131 | 07/01/2036 | DP | RX | 04/25/2024 | |||
| N211349 | GILTERITINIB FUMARATE | XOSPATA | TABLET | ORAL | EQ 40MG BASE | 11938132 | 07/01/2036 | DP | RX | 04/25/2024 | |||
| N211349 | GILTERITINIB FUMARATE | XOSPATA | TABLET | ORAL | EQ 40MG BASE | 11938133 | 07/01/2036 | DP | RX | 04/25/2024 | |||
| N213535 | RISDIPLAM | EVRYSDI | FOR SOLUTION | ORAL | 0.75MG/ML | 11938136 | 11/08/2036 | DP | RX | 04/17/2024 | |||
| N215973 | LENACAPAVIR SODIUM | SUNLENCA | SOLUTION | SUBCUTANEOUS | EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML) | 11944611 | 06/04/2041 | U-3507 | RX | 04/23/2024 | |||
| N215974 | LENACAPAVIR SODIUM | SUNLENCA | TABLET | ORAL | EQ 300MG BASE | 11944611 | 06/04/2041 | DS | DP | U-3507 | RX | 04/23/2024 | |
| N211349 | GILTERITINIB FUMARATE | XOSPATA | TABLET | ORAL | EQ 40MG BASE | 11944620 | 07/01/2036 | DP | RX | 04/25/2024 | |||
| N217677 | NIROGACESTAT HYDROBROMIDE | OGSIVEO | TABLET | ORAL | EQ 50MG BASE | 11951096 | 05/19/2043 | U-3754 | RX | 04/24/2024 | |||
| N217677 | NIROGACESTAT HYDROBROMIDE | OGSIVEO | TABLET | ORAL | EQ 100MG BASE | 11951096 | 05/19/2043 | U-3754 | RX | 04/24/2024 | |||
| N217677 | NIROGACESTAT HYDROBROMIDE | OGSIVEO | TABLET | ORAL | EQ 150MG BASE | 11951096 | 05/19/2043 | U-3754 | RX | 04/24/2024 | |||
| N213378 | OLANZAPINE; SAMIDORPHAN L-MALATE | LYBALVI | TABLET | ORAL | 20MG;EQ 10MG BASE | 11951111 | 11/12/2041 | U-3886 | RX | 04/24/2024 | |||
| N213378 | OLANZAPINE; SAMIDORPHAN L-MALATE | LYBALVI | TABLET | ORAL | 20MG;EQ 10MG BASE | 11951111 | 11/12/2041 | U-3887 | RX | 04/24/2024 | |||
| N213378 | OLANZAPINE; SAMIDORPHAN L-MALATE | LYBALVI | TABLET | ORAL | 5MG;EQ 10MG BASE | 11951111 | 11/12/2041 | U-3886 | RX | 04/24/2024 | |||
| N213378 | OLANZAPINE; SAMIDORPHAN L-MALATE | LYBALVI | TABLET | ORAL | 5MG;EQ 10MG BASE | 11951111 | 11/12/2041 | U-3887 | RX | 04/24/2024 | |||
| N213378 | OLANZAPINE; SAMIDORPHAN L-MALATE | LYBALVI | TABLET | ORAL | 15MG;EQ 10MG BASE | 11951111 | 11/12/2041 | U-3886 | RX | 04/24/2024 | |||
| N213378 | OLANZAPINE; SAMIDORPHAN L-MALATE | LYBALVI | TABLET | ORAL | 15MG;EQ 10MG BASE | 11951111 | 11/12/2041 | U-3887 | RX | 04/24/2024 | |||
| N213378 | OLANZAPINE; SAMIDORPHAN L-MALATE | LYBALVI | TABLET | ORAL | 10MG;EQ 10MG BASE | 11951111 | 11/12/2041 | U-3886 | RX | 04/24/2024 | |||
| N213378 | OLANZAPINE; SAMIDORPHAN L-MALATE | LYBALVI | TABLET | ORAL | 10MG;EQ 10MG BASE | 11951111 | 11/12/2041 | U-3887 | RX | 04/24/2024 | |||
| N216285 | DROSPIRENONE | DROSPIRENONE | TABLET, CHEWABLE | ORAL | 3.5MG | 11951213 | 06/28/2031 | U-2553 | DISCN | 04/25/2024 | |||
| N211367 | DROSPIRENONE | SLYND | TABLET | ORAL | 4MG | 11951213 | 06/28/2031 | U-2553 | RX | 04/25/2024 | |||
| N217677 | NIROGACESTAT HYDROBROMIDE | OGSIVEO | TABLET | ORAL | EQ 50MG BASE | 11957662 | 05/19/2043 | U-3754 | RX | 04/24/2024 | |||
| N217677 | NIROGACESTAT HYDROBROMIDE | OGSIVEO | TABLET | ORAL | EQ 100MG BASE | 11957662 | 05/19/2043 | U-3754 | RX | 04/24/2024 | |||
| N217677 | NIROGACESTAT HYDROBROMIDE | OGSIVEO | TABLET | ORAL | EQ 150MG BASE | 11957662 | 05/19/2043 | U-3754 | RX | 04/24/2024 | |||
| N214846 | ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX | MYFEMBREE | TABLET | ORAL | 1MG;0.5MG;40MG | 11957684 | 09/29/2037 | U-3129 | RX | 04/17/2024 | |||
| N022272 | OXYCODONE HYDROCHLORIDE | OXYCONTIN | TABLET, EXTENDED RELEASE | ORAL | 10MG | 11964056 | 08/24/2027 | DP | RX | 04/25/2024 | |||
| N022272 | OXYCODONE HYDROCHLORIDE | OXYCONTIN | TABLET, EXTENDED RELEASE | ORAL | 15MG | 11964056 | 08/24/2027 | DP | RX | 04/25/2024 | |||
| N022272 | OXYCODONE HYDROCHLORIDE | OXYCONTIN | TABLET, EXTENDED RELEASE | ORAL | 20MG | 11964056 | 08/24/2027 | DP | RX | 04/25/2024 | |||
| N022272 | OXYCODONE HYDROCHLORIDE | OXYCONTIN | TABLET, EXTENDED RELEASE | ORAL | 30MG | 11964056 | 08/24/2027 | DP | RX | 04/25/2024 | |||
| N022272 | OXYCODONE HYDROCHLORIDE | OXYCONTIN | TABLET, EXTENDED RELEASE | ORAL | 40MG | 11964056 | 08/24/2027 | DP | RX | 04/25/2024 | |||
| N022272 | OXYCODONE HYDROCHLORIDE | OXYCONTIN | TABLET, EXTENDED RELEASE | ORAL | 60MG | 11964056 | 08/24/2027 | DP | RX | 04/25/2024 | |||
| N022272 | OXYCODONE HYDROCHLORIDE | OXYCONTIN | TABLET, EXTENDED RELEASE | ORAL | 80MG | 11964056 | 08/24/2027 | DP | RX | 04/25/2024 | |||
| N212608 | AVAPRITINIB | AYVAKIT | TABLET | ORAL | 300MG | 11964980 | 04/10/2040 | DS | DP | RX | 04/23/2024 | ||
| N212608 | AVAPRITINIB | AYVAKIT | TABLET | ORAL | 100MG | 11964980 | 04/10/2040 | DS | DP | RX | 04/23/2024 | ||
| N212608 | AVAPRITINIB | AYVAKIT | TABLET | ORAL | 200MG | 11964980 | 04/10/2040 | DS | DP | RX | 04/23/2024 | ||
| N212608 | AVAPRITINIB | AYVAKIT | TABLET | ORAL | 50MG | 11964980 | 04/10/2040 | DS | DP | RX | 04/23/2024 | ||
| N212608 | AVAPRITINIB | AYVAKIT | TABLET | ORAL | 25MG | 11964980 | 04/10/2040 | DS | DP | RX | 04/23/2024 | ||
| N212904 | TIVOZANIB HYDROCHLORIDE | FOTIVDA | CAPSULE | ORAL | EQ 0.89MG BASE | 6821987 | 04/26/2025 | DS | DP | U-3100 | RX | 04/06/2021 | |
| N212904 | TIVOZANIB HYDROCHLORIDE | FOTIVDA | CAPSULE | ORAL | EQ 1.34MG BASE | 6821987 | 04/26/2025 | DS | DP | U-3100 | RX | 04/06/2021 | |
| N218490 | MACITENTAN; TADALAFIL | OPSYNVI | TABLET | ORAL | 10MG;20MG | 7094781 | 12/05/2025 | DS | DP | RX | 04/18/2024 | ||
| N218490 | MACITENTAN; TADALAFIL | OPSYNVI | TABLET | ORAL | 10MG;40MG | 7094781 | 12/05/2025 | DS | DP | RX | 04/18/2024 | ||
| N217677 | NIROGACESTAT HYDROBROMIDE | OGSIVEO | TABLET | ORAL | EQ 100MG BASE | 7342118 | 08/18/2025 | DS | RX | 04/12/2024 | |||
| N217677 | NIROGACESTAT HYDROBROMIDE | OGSIVEO | TABLET | ORAL | EQ 150MG BASE | 7342118 | 08/18/2025 | DS | RX | 04/12/2024 | |||
| N021196 | SODIUM OXYBATE | XYREM | SOLUTION | ORAL | 0.5GM/ML | 7668730 | 06/16/2024 | U-1110 | Y | RX | |||
| N021196 | SODIUM OXYBATE | XYREM | SOLUTION | ORAL | 0.5GM/ML | 7668730*PED | 12/16/2024 | RX | |||||
| N217677 | NIROGACESTAT HYDROBROMIDE | OGSIVEO | TABLET | ORAL | EQ 100MG BASE | 7795447 | 08/18/2025 | DS | RX | 04/12/2024 | |||
| N217677 | NIROGACESTAT HYDROBROMIDE | OGSIVEO | TABLET | ORAL | EQ 150MG BASE | 7795447 | 08/18/2025 | DS | RX | 04/12/2024 | |||
| N217677 | NIROGACESTAT HYDROBROMIDE | OGSIVEO | TABLET | ORAL | EQ 100MG BASE | 7951958 | 03/11/2025 | DS | RX | 04/12/2024 | |||
| N217677 | NIROGACESTAT HYDROBROMIDE | OGSIVEO | TABLET | ORAL | EQ 150MG BASE | 7951958 | 03/11/2025 | DS | RX | 04/12/2024 | |||
| N218490 | MACITENTAN; TADALAFIL | OPSYNVI | TABLET | ORAL | 10MG;20MG | 8268847 | 04/18/2029 | DP | U-3882 | RX | 04/18/2024 | ||
| N218490 | MACITENTAN; TADALAFIL | OPSYNVI | TABLET | ORAL | 10MG;40MG | 8268847 | 04/18/2029 | DP | U-3882 | RX | 04/18/2024 | ||
| N215192 | VADADUSTAT | VAFSEO | TABLET | ORAL | 150MG | 8323671 | 04/03/2028 | U-3876 | RX | 04/10/2024 | |||
| N215192 | VADADUSTAT | VAFSEO | TABLET | ORAL | 450MG | 8323671 | 04/03/2028 | U-3876 | RX | 04/10/2024 | |||
| N215192 | VADADUSTAT | VAFSEO | TABLET | ORAL | 300MG | 8323671 | 04/03/2028 | U-3876 | RX | 04/10/2024 | |||
| N217686 | APROCITENTAN | TRYVIO | TABLET | ORAL | 12.5MG | 8324232 | 09/21/2029 | DS | DP | U-3878 | RX | 04/16/2024 | |
| N215192 | VADADUSTAT | VAFSEO | TABLET | ORAL | 150MG | 8598210 | 06/26/2027 | DS | DP | RX | 04/10/2024 | ||
| N215192 | VADADUSTAT | VAFSEO | TABLET | ORAL | 450MG | 8598210 | 06/26/2027 | DS | DP | RX | 04/10/2024 | ||
| N215192 | VADADUSTAT | VAFSEO | TABLET | ORAL | 300MG | 8598210 | 06/26/2027 | DS | DP | RX | 04/10/2024 | ||
| N208464 | TENOFOVIR ALAFENAMIDE FUMARATE | VEMLIDY | TABLET | ORAL | EQ 25MG BASE | 8754065 | 08/15/2032 | DS | DP | U-999 | RX | 11/28/2016 | |
| N208464 | TENOFOVIR ALAFENAMIDE FUMARATE | VEMLIDY | TABLET | ORAL | EQ 25MG BASE | 8754065 | 08/15/2032 | DS | DP | U-1275 | RX | 11/28/2016 | |
| N208464 | TENOFOVIR ALAFENAMIDE FUMARATE | VEMLIDY | TABLET | ORAL | EQ 25MG BASE | 8754065 | 08/15/2032 | DS | DP | U-3880 | RX | 11/28/2016 | |
| N208464 | TENOFOVIR ALAFENAMIDE FUMARATE | VEMLIDY | TABLET | ORAL | EQ 25MG BASE | 8754065*PED | 02/15/2033 | RX | |||||
| N215192 | VADADUSTAT | VAFSEO | TABLET | ORAL | 150MG | 8940773 | 06/26/2027 | U-3876 | RX | 04/10/2024 | |||
| N215192 | VADADUSTAT | VAFSEO | TABLET | ORAL | 450MG | 8940773 | 06/26/2027 | U-3876 | RX | 04/10/2024 | |||
| N215192 | VADADUSTAT | VAFSEO | TABLET | ORAL | 300MG | 8940773 | 06/26/2027 | U-3876 | RX | 04/10/2024 | |||
| N203284 | GLYCEROL PHENYLBUTYRATE | RAVICTI | LIQUID | ORAL | 1.1GM/ML | 9254278 | 09/22/2030 | U-1816 | RX | 02/29/2016 | |||
| N208464 | TENOFOVIR ALAFENAMIDE FUMARATE | VEMLIDY | TABLET | ORAL | EQ 25MG BASE | 9296769 | 08/15/2032 | DS | DP | U-999 | RX | 11/28/2016 | |
| N208464 | TENOFOVIR ALAFENAMIDE FUMARATE | VEMLIDY | TABLET | ORAL | EQ 25MG BASE | 9296769 | 08/15/2032 | DS | DP | U-1275 | RX | 11/28/2016 | |
| N208464 | TENOFOVIR ALAFENAMIDE FUMARATE | VEMLIDY | TABLET | ORAL | EQ 25MG BASE | 9296769 | 08/15/2032 | DS | DP | U-3880 | RX | 11/28/2016 | |
| N208464 | TENOFOVIR ALAFENAMIDE FUMARATE | VEMLIDY | TABLET | ORAL | EQ 25MG BASE | 9296769*PED | 02/15/2033 | RX | |||||
| N203284 | GLYCEROL PHENYLBUTYRATE | RAVICTI | LIQUID | ORAL | 1.1GM/ML | 9326966 | 09/22/2030 | U-1816 | RX | 05/25/2016 | |||
| N217865 | GIVINOSTAT HYDROCHLORIDE | DUVYZAT | SUSPENSION | ORAL | EQ 8.86MG BASE/ML | 9421184 | 02/03/2032 | U-3885 | RX | 04/19/2024 | |||
| N213217 | ZANUBRUTINIB | BRUKINSA | CAPSULE | ORAL | 80MG | 9447106 | 04/22/2034 | DS | DP | U-1745 | RX | 11/20/2019 | |
| N213217 | ZANUBRUTINIB | BRUKINSA | CAPSULE | ORAL | 80MG | 9447106 | 04/22/2034 | DS | DP | U-3063 | RX | 11/20/2019 | |
| N213217 | ZANUBRUTINIB | BRUKINSA | CAPSULE | ORAL | 80MG | 9447106 | 04/22/2034 | DS | DP | U-2666 | RX | 11/20/2019 | |
| N213217 | ZANUBRUTINIB | BRUKINSA | CAPSULE | ORAL | 80MG | 9447106 | 04/22/2034 | DS | DP | U-2537 | RX | 11/20/2019 | |
| N213217 | ZANUBRUTINIB | BRUKINSA | CAPSULE | ORAL | 80MG | 9447106 | 04/22/2034 | DS | DP | U-2145 | RX | 11/20/2019 | |
| N213217 | ZANUBRUTINIB | BRUKINSA | CAPSULE | ORAL | 80MG | 9447106 | 04/22/2034 | DS | DP | U-3860 | RX | 11/20/2019 | |
| N213217 | ZANUBRUTINIB | BRUKINSA | CAPSULE | ORAL | 80MG | 9447106 | 04/22/2034 | DS | DP | U-3486 | RX | 11/20/2019 | |
| N217806 | TIRZEPATIDE | ZEPBOUND | SOLUTION | SUBCUTANEOUS | 2.5MG/0.5ML (2.5MG/0.5ML) | 9474780 | 01/05/2036 | DS | DP | RX | 04/18/2024 | ||
| N217806 | TIRZEPATIDE | ZEPBOUND | SOLUTION | SUBCUTANEOUS | 5MG/0.5ML (5MG/0.5ML) | 9474780 | 01/05/2036 | DS | DP | RX | 04/18/2024 | ||
| N217806 | TIRZEPATIDE | ZEPBOUND | SOLUTION | SUBCUTANEOUS | 7.5MG/0.5ML (7.5MG/0.5ML) | 9474780 | 01/05/2036 | DS | DP | RX | 04/18/2024 | ||
| N217806 | TIRZEPATIDE | ZEPBOUND | SOLUTION | SUBCUTANEOUS | 12.5MG/0.5ML (12.5MG/0.5ML) | 9474780 | 01/05/2036 | DS | DP | RX | 04/18/2024 | ||
| N217806 | TIRZEPATIDE | ZEPBOUND | SOLUTION | SUBCUTANEOUS | 10MG/0.5ML (10MG/0.5ML) | 9474780 | 01/05/2036 | DS | DP | RX | 04/18/2024 | ||
| N217806 | TIRZEPATIDE | ZEPBOUND | SOLUTION | SUBCUTANEOUS | 15MG/0.5ML (15MG/0.5ML) | 9474780 | 01/05/2036 | DS | DP | RX | 04/18/2024 | ||
| N215192 | VADADUSTAT | VAFSEO | TABLET | ORAL | 150MG | 9701636 | 11/14/2034 | DS | DP | RX | 04/10/2024 | ||
| N215192 | VADADUSTAT | VAFSEO | TABLET | ORAL | 450MG | 9701636 | 11/14/2034 | DS | DP | RX | 04/10/2024 | ||
| N215192 | VADADUSTAT | VAFSEO | TABLET | ORAL | 300MG | 9701636 | 11/14/2034 | DS | DP | RX | 04/10/2024 | ||
| N215727 | COLCHICINE | LODOCO | TABLET | ORAL | 0.5MG | 9744144 | 11/01/2033 | U-3643 | RX | 06/29/2023 | |||
| N204326 | AMPHETAMINE | ADZENYS XR-ODT | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE | ORAL | EQ 15.7MG BASE | 9839619 | 06/28/2032 | DP | RX | 04/22/2024 | |||
| N204326 | AMPHETAMINE | ADZENYS XR-ODT | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE | ORAL | EQ 3.1MG BASE | 9839619 | 06/28/2032 | DP | RX | 04/22/2024 | |||
| N204326 | AMPHETAMINE | ADZENYS XR-ODT | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE | ORAL | EQ 6.3MG BASE | 9839619 | 06/28/2032 | DP | RX | 04/22/2024 | |||
| N204326 | AMPHETAMINE | ADZENYS XR-ODT | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE | ORAL | EQ 18.8MG BASE | 9839619 | 06/28/2032 | DP | RX | 04/22/2024 | |||
| N204326 | AMPHETAMINE | ADZENYS XR-ODT | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE | ORAL | EQ 12.5MG BASE | 9839619 | 06/28/2032 | DP | RX | 04/22/2024 | |||
| N204326 | AMPHETAMINE | ADZENYS XR-ODT | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE | ORAL | EQ 9.4MG BASE | 9839619 | 06/28/2032 | DP | RX | 04/22/2024 | |||
| N217865 | GIVINOSTAT HYDROCHLORIDE | DUVYZAT | SUSPENSION | ORAL | EQ 8.86MG BASE/ML | 9867799 | 02/03/2032 | U-3885 | RX | 04/19/2024 | |||
| N215192 | VADADUSTAT | VAFSEO | TABLET | ORAL | 150MG | 9987262 | 11/14/2034 | U-3876 | RX | 04/10/2024 | |||
| N215192 | VADADUSTAT | VAFSEO | TABLET | ORAL | 450MG | 9987262 | 11/14/2034 | U-3876 | RX | 04/10/2024 | |||
| N215192 | VADADUSTAT | VAFSEO | TABLET | ORAL | 300MG | 9987262 | 11/14/2034 | U-3876 | RX | 04/10/2024 | |||
| N215192 | VADADUSTAT | VAFSEO | TABLET | ORAL | 150MG | RE47437 | 06/26/2027 | DS | DP | RX | 04/10/2024 | ||
| N215192 | VADADUSTAT | VAFSEO | TABLET | ORAL | 450MG | RE47437 | 06/26/2027 | DS | DP | RX | 04/10/2024 | ||
| N215192 | VADADUSTAT | VAFSEO | TABLET | ORAL | 300MG | RE47437 | 06/26/2027 | DS | DP | RX | 04/10/2024 |
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Last Updated April 26, 2024.