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
N206353 ATAZANAVIR SULFATE; COBICISTAT EVOTAZ TABLET ORAL EQ 300MG BASE;150MG 10039718 10/06/2032 DP
RX 09/05/2018
N211710 LAROTRECTINIB SULFATE VITRAKVI SOLUTION ORAL EQ 20MG BASE/ML 10668072 04/04/2037 DP
RX 09/17/2020
N212725 ENTRECTINIB ROZLYTREK CAPSULE ORAL 200MG 10738037 05/18/2037 DS DP
U-2946 TREATMENT OF COLORECTAL CANCER THAT HAS A NEUROTROPHIC TYROSINE RECEPTOR KINASE(NTRK) GENE FUSION
RX 09/09/2020
N212725 ENTRECTINIB ROZLYTREK CAPSULE ORAL 100MG 10738037 05/18/2037 DS DP
U-2946 TREATMENT OF COLORECTAL CANCER THAT HAS A NEUROTROPHIC TYROSINE RECEPTOR KINASE(NTRK) GENE FUSION
RX 09/09/2020
N205552 IBRUTINIB IMBRUVICA CAPSULE ORAL 140MG 10751342 06/03/2031
U-1491 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
RX 09/10/2020
N205552 IBRUTINIB IMBRUVICA CAPSULE ORAL 140MG 10751342 06/03/2031
U-2943 TREATMENT OF RELAPSED OR REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA
RX 09/10/2020
N205552 IBRUTINIB IMBRUVICA CAPSULE ORAL 140MG 10751342 06/03/2031
U-2944 TREATMENT OF RELAPSED OR REFRACTORY SMALL LYMPHOCYTIC LYMPHOMA
RX 09/10/2020
N205552 IBRUTINIB IMBRUVICA CAPSULE ORAL 140MG 10751342 06/03/2031
U-1946 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
RX 09/10/2020
N205552 IBRUTINIB IMBRUVICA CAPSULE ORAL 70MG 10751342 06/03/2031
U-1491 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
RX 09/10/2020
N205552 IBRUTINIB IMBRUVICA CAPSULE ORAL 70MG 10751342 06/03/2031
U-2943 TREATMENT OF RELAPSED OR REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA
RX 09/10/2020
N205552 IBRUTINIB IMBRUVICA CAPSULE ORAL 70MG 10751342 06/03/2031
U-2944 TREATMENT OF RELAPSED OR REFRACTORY SMALL LYMPHOCYTIC LYMPHOMA
RX 09/10/2020
N205552 IBRUTINIB IMBRUVICA CAPSULE ORAL 70MG 10751342 06/03/2031
U-1946 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
RX 09/10/2020
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 560MG 10751342 06/03/2031
U-1491 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
RX 09/10/2020
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 560MG 10751342 06/03/2031
U-2943 TREATMENT OF RELAPSED OR REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA
RX 09/10/2020
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 560MG 10751342 06/03/2031
U-2944 TREATMENT OF RELAPSED OR REFRACTORY SMALL LYMPHOCYTIC LYMPHOMA
RX 09/10/2020
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 560MG 10751342 06/03/2031
U-1946 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
RX 09/10/2020
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 420MG 10751342 06/03/2031
U-1491 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
RX 09/10/2020
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 420MG 10751342 06/03/2031
U-2943 TREATMENT OF RELAPSED OR REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA
RX 09/10/2020
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 420MG 10751342 06/03/2031
U-2944 TREATMENT OF RELAPSED OR REFRACTORY SMALL LYMPHOCYTIC LYMPHOMA
RX 09/10/2020
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 420MG 10751342 06/03/2031
U-1946 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
RX 09/10/2020
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 280MG 10751342 06/03/2031
U-1491 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
RX 09/10/2020
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 280MG 10751342 06/03/2031
U-2943 TREATMENT OF RELAPSED OR REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA
RX 09/10/2020
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 280MG 10751342 06/03/2031
U-2944 TREATMENT OF RELAPSED OR REFRACTORY SMALL LYMPHOCYTIC LYMPHOMA
RX 09/10/2020
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 280MG 10751342 06/03/2031
U-1946 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
RX 09/10/2020
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 140MG 10751342 06/03/2031
U-1491 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
RX 09/10/2020
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 140MG 10751342 06/03/2031
U-2943 TREATMENT OF RELAPSED OR REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA
RX 09/10/2020
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 140MG 10751342 06/03/2031
U-2944 TREATMENT OF RELAPSED OR REFRACTORY SMALL LYMPHOCYTIC LYMPHOMA
RX 09/10/2020
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 140MG 10751342 06/03/2031
U-1946 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
RX 09/10/2020
N205552 IBRUTINIB IMBRUVICA CAPSULE ORAL 140MG 10752634 06/03/2033 DP
RX 09/10/2020
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 140MG 10752634 06/03/2033 DP
RX 09/10/2020
N207999 OBETICHOLIC ACID OCALIVA TABLET ORAL 10MG 10758549 04/26/2036
U-2945 TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC) IN COMBINATION WITH URSODEOXYCHOLIC ACID (UDCA) IN ADULTS WITH AN INADEQUATE RESPONSE TO UDCA, OR AS MONOTHERAPY IN ADULTS UNABLE TO TOLERATE UDCA
RX 09/10/2020
N207999 OBETICHOLIC ACID OCALIVA TABLET ORAL 5MG 10758549 04/26/2036
U-2945 TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC) IN COMBINATION WITH URSODEOXYCHOLIC ACID (UDCA) IN ADULTS WITH AN INADEQUATE RESPONSE TO UDCA, OR AS MONOTHERAPY IN ADULTS UNABLE TO TOLERATE UDCA
RX 09/10/2020
N209627 ETHINYL ESTRADIOL; SEGESTERONE ACETATE ANNOVERA RING VAGINAL 0.013MG/24HR;0.15MG/24HR 10765628 02/01/2039
U-2787 METHOD OF CONTRACEPTION BY INSERTING A VAGINAL SYSTEM FOR UP TO 13 21/7-DAY (IN/OUT) CYCLES, WHEREIN EFFICACY REQUIRES THE SYSTEM CANNOT BE OUT OF THE VAGINA FOR MORE THAN 2 CUMULATIVE HOURS IN ANY SUCH CYCLE WITHOUT USING ALTERNATIVE CONTRACEPTION
RX 09/14/2020
N209627 ETHINYL ESTRADIOL; SEGESTERONE ACETATE ANNOVERA RING VAGINAL 0.013MG/24HR;0.15MG/24HR 10765628 02/01/2039
U-2786 METHOD OF PREVENTING PREGNANCY BY INSERTING A VAGINAL SYSTEM CONTAINING 103 MG OF SEGESTERONE ACETATE AND 17.4 MG ETHINYL ESTRADIOL INTO A VAGINA FOR UP TO THIRTEEN 21/7-DAY (IN/OUT) CYCLES
RX 09/14/2020
N205832 NINTEDANIB ESYLATE OFEV CAPSULE ORAL EQ 150MG BASE 6762180 10/01/2025 DS DP
RX 10/22/2014
N205832 NINTEDANIB ESYLATE OFEV CAPSULE ORAL EQ 100MG BASE 6762180 10/01/2025 DS DP
RX 10/22/2014
N205552 IBRUTINIB IMBRUVICA CAPSULE ORAL 140MG 8008309 11/13/2027 DS DP
RX 12/12/2013
N205552 IBRUTINIB IMBRUVICA CAPSULE ORAL 70MG 8008309 11/13/2027 DS DP
RX 01/19/2018
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 560MG 8008309 11/13/2027 DS DP
RX 03/06/2018
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 420MG 8008309 11/13/2027 DS DP
RX 03/06/2018
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 280MG 8008309 11/13/2027 DS DP
RX 03/06/2018
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 140MG 8008309 11/13/2027 DS DP
RX 03/06/2018
N022219 TESTOSTERONE UNDECANOATE AVEED INJECTABLE INTRAMUSCULAR 750MG/3ML (250MG/ML) 8338395 05/08/2027
U-1500 TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE; PRIMARY HYPOGONADISM (CONGENITAL OR ACQUIRED); HYPOGONADOTROPIC HYPOGONADISM (CONGENITAL OR ACQUIRED).
RX
N210045 AMLODIPINE BESYLATE; CELECOXIB CONSENSI TABLET ORAL EQ 5MG BASE;200MG 9408837 02/28/2030
U-2410 TREATMENT OF ADULT PATIENTS FOR WHOM TREATMENT WITH BOTH AMLODIPINE FOR HYPERTENSION AND CELECOXIB FOR OSTEOARTHRITIS ARE APPROPRIATE
RX 09/11/2020
N210045 AMLODIPINE BESYLATE; CELECOXIB CONSENSI TABLET ORAL EQ 2.5MG BASE;200MG 9408837 02/28/2030
U-2410 TREATMENT OF ADULT PATIENTS FOR WHOM TREATMENT WITH BOTH AMLODIPINE FOR HYPERTENSION AND CELECOXIB FOR OSTEOARTHRITIS ARE APPROPRIATE
RX 09/11/2020
N210045 AMLODIPINE BESYLATE; CELECOXIB CONSENSI TABLET ORAL EQ 10MG BASE;200MG 9408837 02/28/2030
U-2410 TREATMENT OF ADULT PATIENTS FOR WHOM TREATMENT WITH BOTH AMLODIPINE FOR HYPERTENSION AND CELECOXIB FOR OSTEOARTHRITIS ARE APPROPRIATE
RX 09/11/2020
N213535 RISDIPLAM EVRYSDI FOR SOLUTION ORAL 0.75MG/ML 9586955 02/08/2033 DS DP
RX 09/03/2020
N213535 RISDIPLAM EVRYSDI FOR SOLUTION ORAL 0.75MG/ML 9969754 05/11/2035 DS DP
U-1943 TREATMENT OF SPINAL MUSCULAR ATROPHY
RX 09/03/2020

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Last Updated September 18, 2020.

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