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.
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
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 150MG,N/A;150MG, 100MG 10058546 07/15/2033
U-3022 TREATMENT OF CF IN PATIENTS 12 YEARS AND OLDER WHO HAVE A F508DEL OR G551D CFTR MUTATION AND A 2ND MUTATION SELECTED FROM R117H, A455E, 2789+5G->A, & 3849+10KBC->T, COMPRISING CONCURRENT COADMINISTRATION OF THE COMPOSITIONS OF CLAIM 1 OF US 10058546
RX 09/21/2018
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 150MG,N/A;150MG, 100MG 10058546 07/15/2033
U-3023 TREATMENT OF CF IN PATIENTS 6 YEARS AND OLDER WHO HAVE A F508DEL OR G551D CFTR MUTATION AND A 2ND MUTATION SELECTED FROM R117H, A455E, 2789+5G->A, AND 3849+10KBC->T, COMPRISING CONCURRENT COADMINISTRATION OF THE COMPOSITIONS OF CLAIM 1 OF US 10058546
RX 09/21/2018
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 150MG,N/A;150MG, 100MG 10058546 07/15/2033
U-2399 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS 12 YEARS AND OLDER, WITH A F508DEL OR G551D CFTR GENE MUTATION AND A A455E, 2789+5G->A, OR 3849+10KBC->T MUTATION, COMPRISING CONCURRENT COADMINISTRATION OF THE COMPOSITIONS OF CLAIM 1 OF U.S PATENT 10058546
RX 09/21/2018
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 150MG,N/A;150MG, 100MG 10058546 07/15/2033
U-2572 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS 6 YEARS AND OLDER, WITH A F508DEL OR G551D CFTR GENE MUTATION AND A A455E, 2789+5G->, OR 3849+10KBC->T MUTATION, COMPRISING CONCURRENT COADMINISTRATION OF THE COMPOSITIONS OF CLAIM 1 OF U.S. PATENT 10058546
RX 09/21/2018
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 75MG,N/A;75MG, 50MG 10058546 07/15/2033
U-3022 TREATMENT OF CF IN PATIENTS 12 YEARS AND OLDER WHO HAVE A F508DEL OR G551D CFTR MUTATION AND A 2ND MUTATION SELECTED FROM R117H, A455E, 2789+5G->A, & 3849+10KBC->T, COMPRISING CONCURRENT COADMINISTRATION OF THE COMPOSITIONS OF CLAIM 1 OF US 10058546
RX 07/17/2019
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 75MG,N/A;75MG, 50MG 10058546 07/15/2033
U-3023 TREATMENT OF CF IN PATIENTS 6 YEARS AND OLDER WHO HAVE A F508DEL OR G551D CFTR MUTATION AND A 2ND MUTATION SELECTED FROM R117H, A455E, 2789+5G->A, AND 3849+10KBC->T, COMPRISING CONCURRENT COADMINISTRATION OF THE COMPOSITIONS OF CLAIM 1 OF US 10058546
RX 07/17/2019
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 75MG,N/A;75MG, 50MG 10058546 07/15/2033
U-2399 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS 12 YEARS AND OLDER, WITH A F508DEL OR G551D CFTR GENE MUTATION AND A A455E, 2789+5G->A, OR 3849+10KBC->T MUTATION, COMPRISING CONCURRENT COADMINISTRATION OF THE COMPOSITIONS OF CLAIM 1 OF U.S PATENT 10058546
RX 07/17/2019
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 75MG,N/A;75MG, 50MG 10058546 07/15/2033
U-2572 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS 6 YEARS AND OLDER, WITH A F508DEL OR G551D CFTR GENE MUTATION AND A A455E, 2789+5G->, OR 3849+10KBC->T MUTATION, COMPRISING CONCURRENT COADMINISTRATION OF THE COMPOSITIONS OF CLAIM 1 OF U.S. PATENT 10058546
RX 07/17/2019
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 150MG,N/A;150MG, 100MG 10081621 03/25/2031 DP
U-3024 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 12 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR WHO HAVE AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,081,621
RX 10/25/2018
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 150MG,N/A;150MG, 100MG 10081621 03/25/2031 DP
U-3025 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 6 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR WHO HAVE AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,081,621
RX 10/25/2018
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 150MG,N/A;150MG, 100MG 10081621 03/25/2031 DP
U-2420 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGES 12 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR ONE F508DEL MUTATION AND A CFTR MUTATION PREDICTED TO BE RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,081,621
RX 10/25/2018
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 150MG,N/A;150MG, 100MG 10081621 03/25/2031 DP
U-2571 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGES 6 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR ONE F508DEL MUTATION AND A CFTR MUTATION PREDICTED TO BE RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,081,621
RX 10/25/2018
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 75MG,N/A;75MG, 50MG 10081621 03/25/2031 DP
U-3024 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 12 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR WHO HAVE AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,081,621
RX 07/17/2019
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 75MG,N/A;75MG, 50MG 10081621 03/25/2031 DP
U-3025 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 6 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR WHO HAVE AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,081,621
RX 07/17/2019
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 75MG,N/A;75MG, 50MG 10081621 03/25/2031 DP
U-2420 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGES 12 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR ONE F508DEL MUTATION AND A CFTR MUTATION PREDICTED TO BE RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,081,621
RX 07/17/2019
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 75MG,N/A;75MG, 50MG 10081621 03/25/2031 DP
U-2571 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGES 6 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR ONE F508DEL MUTATION AND A CFTR MUTATION PREDICTED TO BE RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,081,621
RX 07/17/2019
N212273 ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR TRIKAFTA (COPACKAGED) TABLET, TABLET ORAL 100MG,75MG,50MG;N/A,150MG,N/A 10081621 03/25/2031 DP
U-3032 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH A COMPOSITION ACCORDING TO CLAIM 1 OF US 10081621
RX 11/14/2019
N212273 ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR TRIKAFTA (COPACKAGED) TABLET, TABLET ORAL 100MG,75MG,50MG;N/A,150MG,N/A 10081621 03/25/2031 DP
U-2652 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH A COMPOSITION ACCORDING TO CLAIM 1 OF US 10081621
RX 11/14/2019
N202860 NITRIC OXIDE GENOSYL GAS INHALATION 800PPM 10124142 08/18/2025
U-3037 A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT
RX 01/15/2021
N208065 OSIMERTINIB MESYLATE TAGRISSO TABLET ORAL EQ 40MG BASE 10183020 01/02/2035 DP
U-3016 ADJUVANT THERAPY AFTER TUMOR RESECTION IN PATIENTS WITH NON-SMALL CELL LUNG CANCER(NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19DELETIONS OR EXON 21 L858R MUTATIONS
RX 02/12/2019
N208065 OSIMERTINIB MESYLATE TAGRISSO TABLET ORAL EQ 40MG BASE 10183020 01/02/2035 DP
U-1777 TREATMENT OF PATIENTS WITH METASTATIC EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) T790M MUTATION-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC), WHO HAVE PROGRESSED ON OR AFTER EGFR TKI THERAPY
RX 02/12/2019
N208065 OSIMERTINIB MESYLATE TAGRISSO TABLET ORAL EQ 40MG BASE 10183020 01/02/2035 DP
U-2289 TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19 DELETIONS OR EXON 21L858R MUTATIONS
RX 02/12/2019
N208065 OSIMERTINIB MESYLATE TAGRISSO TABLET ORAL EQ 80MG BASE 10183020 01/02/2035 DP
U-3016 ADJUVANT THERAPY AFTER TUMOR RESECTION IN PATIENTS WITH NON-SMALL CELL LUNG CANCER(NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19DELETIONS OR EXON 21 L858R MUTATIONS
RX 02/12/2019
N208065 OSIMERTINIB MESYLATE TAGRISSO TABLET ORAL EQ 80MG BASE 10183020 01/02/2035 DP
U-1777 TREATMENT OF PATIENTS WITH METASTATIC EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) T790M MUTATION-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC), WHO HAVE PROGRESSED ON OR AFTER EGFR TKI THERAPY
RX 02/12/2019
N208065 OSIMERTINIB MESYLATE TAGRISSO TABLET ORAL EQ 80MG BASE 10183020 01/02/2035 DP
U-2289 TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19 DELETIONS OR EXON 21L858R MUTATIONS
RX 02/12/2019
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 150MG,N/A;150MG, 100MG 10206877 04/14/2035 DP
U-3026 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 12 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,206,877
RX 03/20/2019
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 150MG,N/A;150MG, 100MG 10206877 04/14/2035 DP
U-3027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 6 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,206,877
RX 03/20/2019
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 150MG,N/A;150MG, 100MG 10206877 04/14/2035 DP
U-2498 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGES 12 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR ONE F508DEL MUTATION AND A CFTR MUTATION PREDICTED TO BE RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,206,877
RX 03/20/2019
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 150MG,N/A;150MG, 100MG 10206877 04/14/2035 DP
U-2570 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGES 6 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR ONE F508DEL MUTATION AND A CFTR MUTATION PREDICTED TO BE RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,206,877
RX 03/20/2019
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 75MG,N/A;75MG, 50MG 10206877 04/14/2035 DP
U-3026 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 12 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,206,877
RX 07/17/2019
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 75MG,N/A;75MG, 50MG 10206877 04/14/2035 DP
U-3027 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 6 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,206,877
RX 07/17/2019
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 75MG,N/A;75MG, 50MG 10206877 04/14/2035 DP
U-2498 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGES 12 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR ONE F508DEL MUTATION AND A CFTR MUTATION PREDICTED TO BE RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,206,877
RX 07/17/2019
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 75MG,N/A;75MG, 50MG 10206877 04/14/2035 DP
U-2570 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGES 6 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR ONE F508DEL MUTATION AND A CFTR MUTATION PREDICTED TO BE RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,206,877
RX 07/17/2019
N212273 ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR TRIKAFTA (COPACKAGED) TABLET, TABLET ORAL 100MG,75MG,50MG;N/A,150MG,N/A 10239867 04/09/2027 DS DP
U-3033 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA
RX 11/14/2019
N212273 ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR TRIKAFTA (COPACKAGED) TABLET, TABLET ORAL 100MG,75MG,50MG;N/A,150MG,N/A 10239867 04/09/2027 DS DP
U-2653 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
RX 11/14/2019
N213189 TIRBANIBULIN KLISYRI OINTMENT TOPICAL 1% 10323001 12/28/2027 DP
RX 01/12/2021
N214621 RELUGOLIX ORGOVYX TABLET ORAL 120MG 10350170 02/25/2036 DP
RX 01/14/2021
N214621 RELUGOLIX ORGOVYX TABLET ORAL 120MG 10449191 09/29/2037
U-3020 TREATMENT OF ADULT PATIENTS WITH ADVANCED PROSTATE CANCER
RX 01/14/2021
N212306 SELINEXOR XPOVIO TABLET ORAL 20MG 10519139 08/14/2035 DS DP
U-2855 XPOVIO IS INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL), NOT OTHERWISE SPECIFIED, INCLUDING DLBCL ARISING FROM FOLLICULAR LYMPHOMA, AFTER AT LEAST 2 LINES OF SYSTEMIC THERAPY
RX 01/27/2020
N212306 SELINEXOR XPOVIO TABLET ORAL 20MG 10519139 08/14/2035 DS DP
U-3018 XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
RX 01/27/2020
N212306 SELINEXOR XPOVIO TABLET ORAL 20MG 10519139 08/14/2035 DS DP
U-2584 XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES
RX 01/27/2020
N212306 SELINEXOR XPOVIO TABLET ORAL 20MG 10544108 07/26/2032
U-3018 XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
RX 02/24/2020
N212306 SELINEXOR XPOVIO TABLET ORAL 20MG 10544108 07/26/2032
U-2584 XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES
RX 02/24/2020
N213189 TIRBANIBULIN KLISYRI OINTMENT TOPICAL 1% 10617693 03/12/2038
U-3015 TOPICAL TREATMENT OF ACTINIC KERATOSIS OF THE FACE OR SCALP
RX 01/12/2021
N213189 TIRBANIBULIN KLISYRI OINTMENT TOPICAL 1% 10669236 09/07/2038 DS DP
RX 01/12/2021
N212273 ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR TRIKAFTA (COPACKAGED) TABLET, TABLET ORAL 100MG,75MG,50MG;N/A,150MG,N/A 10758534 10/06/2035 DS DP
U-3028 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
RX 09/22/2020
N212273 ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR TRIKAFTA (COPACKAGED) TABLET, TABLET ORAL 100MG,75MG,50MG;N/A,150MG,N/A 10758534 10/06/2035 DS DP
U-2645 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
RX 09/22/2020
N214621 RELUGOLIX ORGOVYX TABLET ORAL 120MG 10786501 09/29/2037
U-3020 TREATMENT OF ADULT PATIENTS WITH ADVANCED PROSTATE CANCER
RX 01/14/2021
N212273 ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR TRIKAFTA (COPACKAGED) TABLET, TABLET ORAL 100MG,75MG,50MG;N/A,150MG,N/A 10793547 12/08/2037 DS DP
U-3028 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
RX 10/29/2020
N212273 ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR TRIKAFTA (COPACKAGED) TABLET, TABLET ORAL 100MG,75MG,50MG;N/A,150MG,N/A 10793547 12/08/2037 DS DP
U-2645 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
RX 10/29/2020
N202860 NITRIC OXIDE GENOSYL GAS INHALATION 800PPM 10814092 10/17/2025
U-3037 A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT
RX 01/15/2021
N202514 TAFLUPROST ZIOPTAN SOLUTION/DROPS OPHTHALMIC 0.0015% 10864159 05/28/2029 DP
U-778 REDUCTION OF ELEVATED INTRAOCULAR PRESSURE IN PATIENTS WITH OPEN ANGLE GLAUCOMA OR OCULAR HYPERTENSION
RX 01/08/2021
N021196 SODIUM OXYBATE XYREM SOLUTION ORAL 0.5GM/ML 10864181 03/15/2033
U-1532 METHOD OF TREATING EXCESSIVE DAYTIME SLEEPINESS AND/OR CATAPLEXY IN NARCOLEPSY PATIENTS WITH SODIUM OXYBATE WHEN DIVALPROEX SODIUM IS CONCOMITANTLY ADMINISTERED.
RX 01/13/2021
N212690 CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE XYWAV SOLUTION ORAL 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML 10864181 03/15/2033
U-3017 METHOD OF TREATING EXCESSIVE DAYTIME SLEEPINESS AND/OR CATAPLEXY IN NARCOLEPSY PATIENTS WITH A SALT OF GAMMA-HYDROXYBUTYRATE WHEN DIVALPROEX SODIUM IS CONCOMITANTLY ADMINISTERED
RX 01/13/2021
N203567 EFINACONAZOLE JUBLIA SOLUTION TOPICAL 10% 10864274 10/02/2034
U-2720 ANTIMYCOTIC USES, SPECIFICALLY TREATMENT OF ONYCHOMYCOSIS; TOPICAL TREATMENT OF THE TOENAIL(S) DUE TO TRICHOPHYTON RUBRUM AND TRICHOPHYTON MENTAGROPHYTES
RX 01/07/2021
N211243 ESKETAMINE HYDROCHLORIDE SPRAVATO SPRAY NASAL EQ 28MG BASE 10869844 09/10/2035
U-3035 TREATMENT OF DEPRESSIVE SYMPTOMS IN ADULTS WITH MDD WITH ACUTE SUICIDAL IDEATION OR BEHAVIOR BY NASALLY ADMINISTERING 56MG OR 84 MG OF ESKETAMINE 2X WEEKLY FOR 4 WEEKS IN CONJUNCTION WITH AN ORAL ANTIDEPRESSANT
RX 01/15/2021
N211243 ESKETAMINE HYDROCHLORIDE SPRAVATO SPRAY NASAL EQ 28MG BASE 10869844 09/10/2035
U-3036 TREATMENT OF TRD IN ADULTS BY NASALLY ADMINISTERING 56MG OR 84MG OF ESKETAMINE 2X WEEKLY FOR 4 WEEKS DURING THE INDUCTION PHASE FOLLOWED BY A MAINTENANCE PHASE OF 56MG OR 84 MG WEEKLY OR 1X EVERY TWO WEEKS IN CONJUNCTION WITH AN ORAL ANTIDEPRESSANT
RX 01/15/2021
N211243 ESKETAMINE HYDROCHLORIDE SPRAVATO SPRAY NASAL EQ 28MG BASE 10869844 09/10/2035
U-3034 TREATMENT OF TRD IN ADULTS BY NASALLY ADMINISTERING 56MG OR 84MG OF ESKETAMINE 2X WEEKLY FOR 4 WEEKS DURING THE INDUCTION PHASE IN CONJUNCTION WITH AN ORAL ANTIDEPRESSENT
RX 01/15/2021
N208623 MIGALASTAT HYDROCHLORIDE GALAFOLD CAPSULE ORAL EQ 123MG BASE 10874655 05/30/2038
U-2371 THE TREATMENT OF FABRY PATIENTS
RX 01/07/2021
N208623 MIGALASTAT HYDROCHLORIDE GALAFOLD CAPSULE ORAL EQ 123MG BASE 10874656 05/30/2038
U-2371 THE TREATMENT OF FABRY PATIENTS
RX 01/07/2021
N208623 MIGALASTAT HYDROCHLORIDE GALAFOLD CAPSULE ORAL EQ 123MG BASE 10874657 05/30/2038
U-2371 THE TREATMENT OF FABRY PATIENTS
RX 01/07/2021
N210875 APOMORPHINE HYDROCHLORIDE KYNMOBI FILM SUBLINGUAL 15MG 10888499 02/14/2022 DP
RX 01/14/2021
N210875 APOMORPHINE HYDROCHLORIDE KYNMOBI FILM SUBLINGUAL 25MG 10888499 02/14/2022 DP
RX 01/14/2021
N210875 APOMORPHINE HYDROCHLORIDE KYNMOBI FILM SUBLINGUAL 10MG 10888499 02/14/2022 DP
RX 01/14/2021
N210875 APOMORPHINE HYDROCHLORIDE KYNMOBI FILM SUBLINGUAL 20MG 10888499 02/14/2022 DP
RX 01/14/2021
N210875 APOMORPHINE HYDROCHLORIDE KYNMOBI FILM SUBLINGUAL 30MG 10888499 02/14/2022 DP
RX 01/14/2021
N213189 TIRBANIBULIN KLISYRI OINTMENT TOPICAL 1% 7300931 02/06/2026 DS DP
RX 01/12/2021
N214621 RELUGOLIX ORGOVYX TABLET ORAL 120MG 7300935 01/28/2024 DS
RX 01/14/2021
N213189 TIRBANIBULIN KLISYRI OINTMENT TOPICAL 1% 7851470 02/02/2029 DS DP
U-3015 TOPICAL TREATMENT OF ACTINIC KERATOSIS OF THE FACE OR SCALP
RX 01/12/2021
N202860 NITRIC OXIDE GENOSYL GAS INHALATION 800PPM 7947227 10/17/2026
U-3037 A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT
RX 01/15/2021
N202860 NITRIC OXIDE GENOSYL GAS INHALATION 800PPM 8057742 01/18/2026
U-3037 A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT
RX 01/15/2021
N214621 RELUGOLIX ORGOVYX TABLET ORAL 120MG 8058280 01/28/2024 DS DP
RX 01/14/2021
N203469 PONATINIB HYDROCHLORIDE ICLUSIG TABLET ORAL EQ 30MG BASE 8114874 01/24/2027 DS DP
RX 06/09/2015
N203469 PONATINIB HYDROCHLORIDE ICLUSIG TABLET ORAL EQ 10MG BASE 8114874 01/24/2027 DS DP
RX 01/14/2021
N202860 NITRIC OXIDE GENOSYL GAS INHALATION 800PPM 8226916 08/18/2025
U-3037 A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT
RX 01/15/2021
N213189 TIRBANIBULIN KLISYRI OINTMENT TOPICAL 1% 8236799 12/28/2025 DS DP
RX 01/12/2021
N212273 ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR TRIKAFTA (COPACKAGED) TABLET, TABLET ORAL 100MG,75MG,50MG;N/A,150MG,N/A 8324242 08/05/2027
U-3028 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
RX 11/14/2019
N212273 ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR TRIKAFTA (COPACKAGED) TABLET, TABLET ORAL 100MG,75MG,50MG;N/A,150MG,N/A 8324242 08/05/2027
U-2645 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
RX 11/14/2019
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 150MG,N/A;150MG, 100MG 8354427 07/06/2026
U-3021 TEZACAFTOR AND IVACAFTOR FOR THE TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 6 YEARS AND OLDER WHO HAVE A R117H MUTATION IN THE CFTR GENE
RX 01/14/2021
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 75MG,N/A;75MG, 50MG 8354427 07/06/2026
U-3021 TEZACAFTOR AND IVACAFTOR FOR THE TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 6 YEARS AND OLDER WHO HAVE A R117H MUTATION IN THE CFTR GENE
RX 01/14/2021
N212273 ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR TRIKAFTA (COPACKAGED) TABLET, TABLET ORAL 100MG,75MG,50MG;N/A,150MG,N/A 8354427 07/06/2026
U-3029 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE A R117H MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
RX 11/14/2019
N212273 ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR TRIKAFTA (COPACKAGED) TABLET, TABLET ORAL 100MG,75MG,50MG;N/A,150MG,N/A 8354427 07/06/2026
U-2646 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE ONE F508DEL MUTATION AND ONE R117H MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
RX 11/14/2019
N212273 ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR TRIKAFTA (COPACKAGED) TABLET, TABLET ORAL 100MG,75MG,50MG;N/A,150MG,N/A 8415387 11/12/2027
U-3028 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
RX 11/14/2019
N212273 ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR TRIKAFTA (COPACKAGED) TABLET, TABLET ORAL 100MG,75MG,50MG;N/A,150MG,N/A 8415387 11/12/2027
U-2645 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
RX 11/14/2019
N212273 ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR TRIKAFTA (COPACKAGED) TABLET, TABLET ORAL 100MG,75MG,50MG;N/A,150MG,N/A 8598181 05/01/2027
U-3028 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
RX 11/14/2019
N212273 ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR TRIKAFTA (COPACKAGED) TABLET, TABLET ORAL 100MG,75MG,50MG;N/A,150MG,N/A 8598181 05/01/2027
U-2645 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
RX 11/14/2019
N202860 NITRIC OXIDE GENOSYL GAS INHALATION 800PPM 8607785 07/14/2030 DP
RX 01/15/2021
N202860 NITRIC OXIDE GENOSYL GAS INHALATION 800PPM 8609028 08/18/2025
U-3037 A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT
RX 01/15/2021
N212273 ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR TRIKAFTA (COPACKAGED) TABLET, TABLET ORAL 100MG,75MG,50MG;N/A,150MG,N/A 8629162 06/24/2025
U-3030 TREATMENT OF A MODERATE TO MILD CLINICAL PHENOTYPE OF CF IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELX, TEZ, AND IVA
RX 11/14/2019
N212273 ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR TRIKAFTA (COPACKAGED) TABLET, TABLET ORAL 100MG,75MG,50MG;N/A,150MG,N/A 8629162 06/24/2025
U-2648 TREATMENT OF A MODERATE TO MILD CLINICAL PHENOTYPE OF CF IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
RX 11/14/2019
N214621 RELUGOLIX ORGOVYX TABLET ORAL 120MG 8735401 02/04/2024
U-3019 TREATMENT OF ADULT PATIENTS WITH ADVANCED PROSTATE CANCER THAT IS SEX-HORMONE-DEPENDENT
RX 01/14/2021
N202860 NITRIC OXIDE GENOSYL GAS INHALATION 800PPM 8821801 08/18/2025 DP
RX 01/15/2021
N202860 NITRIC OXIDE GENOSYL GAS INHALATION 800PPM 8944049 08/13/2029 DP
RX 01/15/2021
N208065 OSIMERTINIB MESYLATE TAGRISSO TABLET ORAL EQ 40MG BASE 8946235 08/08/2032 DS DP
U-3016 ADJUVANT THERAPY AFTER TUMOR RESECTION IN PATIENTS WITH NON-SMALL CELL LUNG CANCER(NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19DELETIONS OR EXON 21 L858R MUTATIONS
RX 12/11/2015
N208065 OSIMERTINIB MESYLATE TAGRISSO TABLET ORAL EQ 40MG BASE 8946235 08/08/2032 DS DP
U-1777 TREATMENT OF PATIENTS WITH METASTATIC EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) T790M MUTATION-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC), WHO HAVE PROGRESSED ON OR AFTER EGFR TKI THERAPY
RX 12/11/2015
N208065 OSIMERTINIB MESYLATE TAGRISSO TABLET ORAL EQ 40MG BASE 8946235 08/08/2032 DS DP
U-2289 TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19 DELETIONS OR EXON 21L858R MUTATIONS
RX 12/11/2015
N208065 OSIMERTINIB MESYLATE TAGRISSO TABLET ORAL EQ 80MG BASE 8946235 08/08/2032 DS DP
U-3016 ADJUVANT THERAPY AFTER TUMOR RESECTION IN PATIENTS WITH NON-SMALL CELL LUNG CANCER(NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19DELETIONS OR EXON 21 L858R MUTATIONS
RX 12/11/2015
N208065 OSIMERTINIB MESYLATE TAGRISSO TABLET ORAL EQ 80MG BASE 8946235 08/08/2032 DS DP
U-1777 TREATMENT OF PATIENTS WITH METASTATIC EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) T790M MUTATION-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC), WHO HAVE PROGRESSED ON OR AFTER EGFR TKI THERAPY
RX 12/11/2015
N208065 OSIMERTINIB MESYLATE TAGRISSO TABLET ORAL EQ 80MG BASE 8946235 08/08/2032 DS DP
U-2289 TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19 DELETIONS OR EXON 21L858R MUTATIONS
RX 12/11/2015
N213189 TIRBANIBULIN KLISYRI OINTMENT TOPICAL 1% 8980890 12/28/2025 DS DP
RX 01/12/2021
N203469 PONATINIB HYDROCHLORIDE ICLUSIG TABLET ORAL EQ 10MG BASE 9029533 12/22/2026
U-836 A METHOD FOR THE TREATMENT OF LEUKEMIAS
RX 01/14/2021
N203469 PONATINIB HYDROCHLORIDE ICLUSIG TABLET ORAL EQ 10MG BASE 9029533 12/22/2026
U-1699 A METHOD FOR TREATING ACUTE LYMPHOBLASTIC LEUKEMIA
RX 01/14/2021
N203469 PONATINIB HYDROCHLORIDE ICLUSIG TABLET ORAL EQ 10MG BASE 9029533 12/22/2026
U-1701 A METHOD FOR TREATING LEUKEMIA RESULTING FROM A MUTATION IN THE BCR-ABL KINASE DOMAIN
RX 01/14/2021
N203469 PONATINIB HYDROCHLORIDE ICLUSIG TABLET ORAL EQ 10MG BASE 9029533 12/22/2026
U-1700 A METHOD FOR TREATING PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA
RX 01/14/2021
N203469 PONATINIB HYDROCHLORIDE ICLUSIG TABLET ORAL EQ 10MG BASE 9029533 12/22/2026
U-1283 A METHOD OF TREATING CHRONIC MYELOGENOUS LEUKEMIA
RX 01/14/2021
N212306 SELINEXOR XPOVIO TABLET ORAL 20MG 9079865 07/26/2032
U-2855 XPOVIO IS INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL), NOT OTHERWISE SPECIFIED, INCLUDING DLBCL ARISING FROM FOLLICULAR LYMPHOMA, AFTER AT LEAST 2 LINES OF SYSTEMIC THERAPY
RX 07/31/2019
N212306 SELINEXOR XPOVIO TABLET ORAL 20MG 9079865 07/26/2032
U-3018 XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
RX 07/31/2019
N212306 SELINEXOR XPOVIO TABLET ORAL 20MG 9079865 07/26/2032
U-2584 XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES
RX 07/31/2019
N203469 PONATINIB HYDROCHLORIDE ICLUSIG TABLET ORAL EQ 10MG BASE 9493470 12/12/2033 DS DP
U-1948 A METHOD FOR TREATING CHRONIC MYELOID LEUKEMIA
RX 01/14/2021
N203469 PONATINIB HYDROCHLORIDE ICLUSIG TABLET ORAL EQ 10MG BASE 9493470 12/12/2033 DS DP
U-1700 A METHOD FOR TREATING PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA
RX 01/14/2021
N202860 NITRIC OXIDE GENOSYL GAS INHALATION 800PPM 9522249 08/18/2025 DP
RX 01/15/2021
N212273 ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR TRIKAFTA (COPACKAGED) TABLET, TABLET ORAL 100MG,75MG,50MG;N/A,150MG,N/A 9670163 12/28/2026 DP
U-3031 TREATMENT OF CF IN PATIENTS 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA USING A SOLID COMPOSITION COMPRISING ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA
RX 11/14/2019
N212273 ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR TRIKAFTA (COPACKAGED) TABLET, TABLET ORAL 100MG,75MG,50MG;N/A,150MG,N/A 9670163 12/28/2026 DP
U-2650 TREATMENT OF CF IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE USING A SOLID COMPOSITION COMPRISING ELEXACAFTOR, TEZACAFTOR, AMORPHOUS IVACAFTOR, AND LESS THAN ABOUT 30% CRYSTALLINE IVACAFTOR
RX 11/14/2019
N202860 NITRIC OXIDE GENOSYL GAS INHALATION 800PPM 9701538 01/28/2029 DP
RX 01/15/2021
N208065 OSIMERTINIB MESYLATE TAGRISSO TABLET ORAL EQ 40MG BASE 9732058 07/25/2032 DS DP
U-3016 ADJUVANT THERAPY AFTER TUMOR RESECTION IN PATIENTS WITH NON-SMALL CELL LUNG CANCER(NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19DELETIONS OR EXON 21 L858R MUTATIONS
RX 08/29/2017
N208065 OSIMERTINIB MESYLATE TAGRISSO TABLET ORAL EQ 40MG BASE 9732058 07/25/2032 DS DP
U-1777 TREATMENT OF PATIENTS WITH METASTATIC EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) T790M MUTATION-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC), WHO HAVE PROGRESSED ON OR AFTER EGFR TKI THERAPY
RX 08/29/2017
N208065 OSIMERTINIB MESYLATE TAGRISSO TABLET ORAL EQ 40MG BASE 9732058 07/25/2032 DS DP
U-2289 TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19 DELETIONS OR EXON 21L858R MUTATIONS
RX 08/29/2017
N208065 OSIMERTINIB MESYLATE TAGRISSO TABLET ORAL EQ 80MG BASE 9732058 07/25/2032 DS DP
U-3016 ADJUVANT THERAPY AFTER TUMOR RESECTION IN PATIENTS WITH NON-SMALL CELL LUNG CANCER(NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19DELETIONS OR EXON 21 L858R MUTATIONS
RX 08/29/2017
N208065 OSIMERTINIB MESYLATE TAGRISSO TABLET ORAL EQ 80MG BASE 9732058 07/25/2032 DS DP
U-1777 TREATMENT OF PATIENTS WITH METASTATIC EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) T790M MUTATION-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC), WHO HAVE PROGRESSED ON OR AFTER EGFR TKI THERAPY
RX 08/29/2017
N208065 OSIMERTINIB MESYLATE TAGRISSO TABLET ORAL EQ 80MG BASE 9732058 07/25/2032 DS DP
U-2289 TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19 DELETIONS OR EXON 21L858R MUTATIONS
RX 08/29/2017
N212273 ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR TRIKAFTA (COPACKAGED) TABLET, TABLET ORAL 100MG,75MG,50MG;N/A,150MG,N/A 9931334 12/28/2026 DP
U-3031 TREATMENT OF CF IN PATIENTS 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA USING A SOLID COMPOSITION COMPRISING ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA
RX 11/14/2019
N212273 ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR TRIKAFTA (COPACKAGED) TABLET, TABLET ORAL 100MG,75MG,50MG;N/A,150MG,N/A 9931334 12/28/2026 DP
U-2650 TREATMENT OF CF IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE USING A SOLID COMPOSITION COMPRISING ELEXACAFTOR, TEZACAFTOR, AMORPHOUS IVACAFTOR, AND LESS THAN ABOUT 30% CRYSTALLINE IVACAFTOR
RX 11/14/2019
N202860 NITRIC OXIDE GENOSYL GAS INHALATION 800PPM 9956373 08/18/2025
U-3037 A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT
RX 01/15/2021
N212273 ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR TRIKAFTA (COPACKAGED) TABLET, TABLET ORAL 100MG,75MG,50MG;N/A,150MG,N/A 9974781 04/09/2027 DP
U-3028 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
RX 11/14/2019
N212273 ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR TRIKAFTA (COPACKAGED) TABLET, TABLET ORAL 100MG,75MG,50MG;N/A,150MG,N/A 9974781 04/09/2027 DP
U-2645 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
RX 11/14/2019

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