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  • Patent information is published on or after the submission date as defined in 21 CFR 314.53(d)(5).
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Patent and Exclusivity for: N208558

Product 002
OLAPARIB (LYNPARZA) TABLET 150MG

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
002 7151102 04/29/2022 DS DP
09/15/2017
002 7449464 10/11/2024 DS DP
09/15/2017
002 7981889 10/11/2024 DS DP
09/15/2017
002 8071579 08/12/2027
U-2101 MAINTENANCE TREATMENT OF RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER, WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY
U-2103 MAINTENANCE TREATMENT OF BRCA-MUTATED RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER, WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY
U-2480 MAINTENANCE TREATMENT OF GBRCA- OR SBRCA-MUTATED ADVANCED EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMOTHERAPY
U-2481 TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE BRCA-MUTATED ADVANCED OVARIAN CANCER WHO HAVE BEEN TREATED WITH THREE OR MORE PRIOR LINES OF CHEMOTHERAPY
U-2482 TREATMENT OF HR-NEGATIVE, HER-2 NEGATIVE, GBRCA-MUTATED METASTATIC BREAST CANCER, WHO HAVE BEEN TREATED WITH CHEMOTHERAPY IN THE NEOADJUVANT, ADJUVANT, OR METASTATIC SETTING
U-2483 TREATMENT OF HR-POSITIVE, HER-2 NEGATIVE, GBRCA-MUTATED METASTATIC BREAST CANCER, WHO HAVE BEEN TREATED WITH CHEMOTHERAPY IN THE NEOADJUVANT, ADJUVANT, OR METASTATIC SETTING, AND WITH ENDOCRINE THERAPY OR ARE INAPPROPRIATE FOR ENDOCRINE THERAPY
U-2716 MAINTENANCE TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GBRCA-MUTATED METASTATIC PANCREATIC ADENOCARCINOMA WHOSE DISEASE HAS NOT PROGRESSED ON AT LEAST 16 WEEKS OF A FIRST-LINE PLATINUM-BASED CHEMOTHERAPY REGIMEN
U-2819 MAINTENANCE TREATMENT WITH BEVACIZUMAB OF ADV. EPITHELIAL OVARIAN CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION
U-2820 MAINTENANCE TREATMENT WITH BEVACIZUMAB OF ADV. EPITHELIAL OVARIAN CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH GENOMIC INSTABILITY
U-2821 MAINTENANCE TREATMENT WITH BEVACIZUMAB OF FALLOPIAN TUBE CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION
U-2822 MAINTENANCE TREATMENT WITH BEVACIZUMAB OF FALLOPIAN TUBE CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH GENOMIC INSTABILITY
U-2823 MAINTENANCE TREATMENT WITH BEVACIZUMAB OF PRIMARY PERITONEAL CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION
U-2824 MAINTENANCE TREATMENT WITH BEVACIZUMAB OF PRIMARY PERITONEAL CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH GENOMIC INSTABILITY
U-2832 TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC HOMOLOGOUS RECOMBINATION REPAIR GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER, WHICH HAS PROGRESSED FOLLOWING PRIOR TREATMENT WITH ENZALUTAMIDE OR ABIRATERONE
U-2833 TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC BRCA-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER, WHICH HAS PROGRESSED FOLLOWING PRIOR TREATMENT WITH ENZALUTAMIDE OR ABIRATERONE
06/18/2020
002 8143241 08/12/2027
U-2101 MAINTENANCE TREATMENT OF RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER, WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY
U-2103 MAINTENANCE TREATMENT OF BRCA-MUTATED RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER, WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY
U-2480 MAINTENANCE TREATMENT OF GBRCA- OR SBRCA-MUTATED ADVANCED EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMOTHERAPY
U-2481 TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE BRCA-MUTATED ADVANCED OVARIAN CANCER WHO HAVE BEEN TREATED WITH THREE OR MORE PRIOR LINES OF CHEMOTHERAPY
U-2482 TREATMENT OF HR-NEGATIVE, HER-2 NEGATIVE, GBRCA-MUTATED METASTATIC BREAST CANCER, WHO HAVE BEEN TREATED WITH CHEMOTHERAPY IN THE NEOADJUVANT, ADJUVANT, OR METASTATIC SETTING
U-2483 TREATMENT OF HR-POSITIVE, HER-2 NEGATIVE, GBRCA-MUTATED METASTATIC BREAST CANCER, WHO HAVE BEEN TREATED WITH CHEMOTHERAPY IN THE NEOADJUVANT, ADJUVANT, OR METASTATIC SETTING, AND WITH ENDOCRINE THERAPY OR ARE INAPPROPRIATE FOR ENDOCRINE THERAPY
U-2716 MAINTENANCE TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GBRCA-MUTATED METASTATIC PANCREATIC ADENOCARCINOMA WHOSE DISEASE HAS NOT PROGRESSED ON AT LEAST 16 WEEKS OF A FIRST-LINE PLATINUM-BASED CHEMOTHERAPY REGIMEN
U-2819 MAINTENANCE TREATMENT WITH BEVACIZUMAB OF ADV. EPITHELIAL OVARIAN CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION
U-2820 MAINTENANCE TREATMENT WITH BEVACIZUMAB OF ADV. EPITHELIAL OVARIAN CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH GENOMIC INSTABILITY
U-2821 MAINTENANCE TREATMENT WITH BEVACIZUMAB OF FALLOPIAN TUBE CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION
U-2822 MAINTENANCE TREATMENT WITH BEVACIZUMAB OF FALLOPIAN TUBE CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH GENOMIC INSTABILITY
U-2823 MAINTENANCE TREATMENT WITH BEVACIZUMAB OF PRIMARY PERITONEAL CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION
U-2824 MAINTENANCE TREATMENT WITH BEVACIZUMAB OF PRIMARY PERITONEAL CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH GENOMIC INSTABILITY
U-2832 TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC HOMOLOGOUS RECOMBINATION REPAIR GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER, WHICH HAS PROGRESSED FOLLOWING PRIOR TREATMENT WITH ENZALUTAMIDE OR ABIRATERONE
U-2833 TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC BRCA-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER, WHICH HAS PROGRESSED FOLLOWING PRIOR TREATMENT WITH ENZALUTAMIDE OR ABIRATERONE
09/15/2017
002 8475842 12/31/2029 DP
09/15/2017
002 8859562 08/04/2031
U-2101 MAINTENANCE TREATMENT OF RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER, WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY
U-2103 MAINTENANCE TREATMENT OF BRCA-MUTATED RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER, WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY
U-2480 MAINTENANCE TREATMENT OF GBRCA- OR SBRCA-MUTATED ADVANCED EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMOTHERAPY
U-2481 TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE BRCA-MUTATED ADVANCED OVARIAN CANCER WHO HAVE BEEN TREATED WITH THREE OR MORE PRIOR LINES OF CHEMOTHERAPY
U-2482 TREATMENT OF HR-NEGATIVE, HER-2 NEGATIVE, GBRCA-MUTATED METASTATIC BREAST CANCER, WHO HAVE BEEN TREATED WITH CHEMOTHERAPY IN THE NEOADJUVANT, ADJUVANT, OR METASTATIC SETTING
U-2483 TREATMENT OF HR-POSITIVE, HER-2 NEGATIVE, GBRCA-MUTATED METASTATIC BREAST CANCER, WHO HAVE BEEN TREATED WITH CHEMOTHERAPY IN THE NEOADJUVANT, ADJUVANT, OR METASTATIC SETTING, AND WITH ENDOCRINE THERAPY OR ARE INAPPROPRIATE FOR ENDOCRINE THERAPY
U-2716 MAINTENANCE TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GBRCA-MUTATED METASTATIC PANCREATIC ADENOCARCINOMA WHOSE DISEASE HAS NOT PROGRESSED ON AT LEAST 16 WEEKS OF A FIRST-LINE PLATINUM-BASED CHEMOTHERAPY REGIMEN
U-2819 MAINTENANCE TREATMENT WITH BEVACIZUMAB OF ADV. EPITHELIAL OVARIAN CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION
U-2820 MAINTENANCE TREATMENT WITH BEVACIZUMAB OF ADV. EPITHELIAL OVARIAN CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH GENOMIC INSTABILITY
U-2821 MAINTENANCE TREATMENT WITH BEVACIZUMAB OF FALLOPIAN TUBE CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION
U-2822 MAINTENANCE TREATMENT WITH BEVACIZUMAB OF FALLOPIAN TUBE CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH GENOMIC INSTABILITY
U-2823 MAINTENANCE TREATMENT WITH BEVACIZUMAB OF PRIMARY PERITONEAL CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION
U-2824 MAINTENANCE TREATMENT WITH BEVACIZUMAB OF PRIMARY PERITONEAL CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH GENOMIC INSTABILITY
U-2832 TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC HOMOLOGOUS RECOMBINATION REPAIR GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER, WHICH HAS PROGRESSED FOLLOWING PRIOR TREATMENT WITH ENZALUTAMIDE OR ABIRATERONE
U-2833 TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC BRCA-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER, WHICH HAS PROGRESSED FOLLOWING PRIOR TREATMENT WITH ENZALUTAMIDE OR ABIRATERONE
09/15/2017
002 8912187 03/12/2024
U-2101 MAINTENANCE TREATMENT OF RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER, WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY
U-2480 MAINTENANCE TREATMENT OF GBRCA- OR SBRCA-MUTATED ADVANCED EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMOTHERAPY
U-2481 TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE BRCA-MUTATED ADVANCED OVARIAN CANCER WHO HAVE BEEN TREATED WITH THREE OR MORE PRIOR LINES OF CHEMOTHERAPY
U-2482 TREATMENT OF HR-NEGATIVE, HER-2 NEGATIVE, GBRCA-MUTATED METASTATIC BREAST CANCER, WHO HAVE BEEN TREATED WITH CHEMOTHERAPY IN THE NEOADJUVANT, ADJUVANT, OR METASTATIC SETTING
U-2483 TREATMENT OF HR-POSITIVE, HER-2 NEGATIVE, GBRCA-MUTATED METASTATIC BREAST CANCER, WHO HAVE BEEN TREATED WITH CHEMOTHERAPY IN THE NEOADJUVANT, ADJUVANT, OR METASTATIC SETTING, AND WITH ENDOCRINE THERAPY OR ARE INAPPROPRIATE FOR ENDOCRINE THERAPY
U-2819 MAINTENANCE TREATMENT WITH BEVACIZUMAB OF ADV. EPITHELIAL OVARIAN CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION
U-2820 MAINTENANCE TREATMENT WITH BEVACIZUMAB OF ADV. EPITHELIAL OVARIAN CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH GENOMIC INSTABILITY
U-2821 MAINTENANCE TREATMENT WITH BEVACIZUMAB OF FALLOPIAN TUBE CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION
U-2822 MAINTENANCE TREATMENT WITH BEVACIZUMAB OF FALLOPIAN TUBE CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH GENOMIC INSTABILITY
U-2823 MAINTENANCE TREATMENT WITH BEVACIZUMAB OF PRIMARY PERITONEAL CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION
U-2824 MAINTENANCE TREATMENT WITH BEVACIZUMAB OF PRIMARY PERITONEAL CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM CHEMOTHERAPY AND HOMOLOGOUS RECOMBINATION DEFICIENCY-POSITIVE WITH GENOMIC INSTABILITY
09/15/2017
002 9169235 03/12/2024
U-2832 TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC HOMOLOGOUS RECOMBINATION REPAIR GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER, WHICH HAS PROGRESSED FOLLOWING PRIOR TREATMENT WITH ENZALUTAMIDE OR ABIRATERONE
U-2833 TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC BRCA-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER, WHICH HAS PROGRESSED FOLLOWING PRIOR TREATMENT WITH ENZALUTAMIDE OR ABIRATERONE
06/18/2020
002 9566276 03/12/2024
U-2716 MAINTENANCE TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GBRCA-MUTATED METASTATIC PANCREATIC ADENOCARCINOMA WHOSE DISEASE HAS NOT PROGRESSED ON AT LEAST 16 WEEKS OF A FIRST-LINE PLATINUM-BASED CHEMOTHERAPY REGIMEN
01/22/2020

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
002
I-762TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE BRCA-MUTATED, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2-NEGATIVE METASTATIC BREAST CANCER WHO HAVE BEEN TREATED WITH CHEMOTHERAPY IN THE NEOADJUVANT, ADJUVANT OR METASTATIC SETTING
COMPETITIVE GENERIC THERAPY
01/12/2021
002
I-776FIRSTLINE MAINTENANCE TX IN PTS W/ DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE, SOMATIC BRCA-MUTATED ADVANCED EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CA WHO ARE IN COMPLETE OR PARTIAL RESPONSE TO FIRSTLINE PLATINUM-BASED CHEMOTHERAPY
COMPETITIVE GENERIC THERAPY
12/19/2021
002
ODE-83USE OF AS MONOTHERAPY FOR PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE BRCA MUTATED (AS DETECTED BY AN FDA-APPROVED TEST) ADVANCED OVARIAN CANCER WHO HAVE BEEN TREATED WITH THREE OR MORE PRIOR LINES OF CHEMOTHERAPY
COMPETITIVE GENERIC THERAPY
12/19/2021
002
I-818MAINTENANCE TREATMENT OF ADULT PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GBRCAM METASTATIC PANCREATIC ADENOCARCINOMA WHOSE DISEASE HAS NOT PROGRESSED ON AT LEAST 16 WEEKS OF A FIRST-LINE PLATINUM-BASED CHEMOTHERAPY REGIMEN
COMPETITIVE GENERIC THERAPY
12/27/2022
002
I-831W/BEVACIZUMAB FOR MAINTENANCE TX OF ADULTS W/ADV. EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CA IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMO & CA ASSOCIATED W/ HOMOLOGOUS RECOMBINATION DEFICIENCY POSITIVE STATUS
COMPETITIVE GENERIC THERAPY
05/08/2023
002
I-832TX OF ADULT PTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC HOMOLOGOUS RECOMBINATION REPAIR GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER WHO HAVE PROGRESSED FOLLOWING PRIOR TREATMENT WITH ENZALUTAMIDE OR ABIRATERONE
COMPETITIVE GENERIC THERAPY
05/19/2023
002
ODE-180MAINTENANCE TREATMENT OF ADULT PATIENTS WITH RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER, WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY
COMPETITIVE GENERIC THERAPY
08/17/2024
002
ODE-181TREATMENT OF ADULT PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE BRCA-MUTATED ADVANCED OVARIAN CANCER WHO HAVE BEEN TREATED WITH THREE OR MORE PRIOR LINES OF CHEMOTHERAPY
COMPETITIVE GENERIC THERAPY
08/17/2024
002
ODE-226MAINTENANCE TREATMENT OF ADULTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC BRCA-MUTATED ADVANCED EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMOTHERAPY
COMPETITIVE GENERIC THERAPY
12/19/2025
002
ODE-283MAINTENANCE TX OF ADULTS W/ DELETERIOUS OR SUSPECTED DELETERIOUS GBRCAM METASTATIC PANCREATIC ADENOCARCINOMA WHOSE DZ HAS NOT PROGRESSED ON >=16WKS OF 1ST LINE PLATINUM BASED CHEMO REGIMEN. SELECT PTS FOR THERAPY BASED ON APPROVED COMPANION DIAGNOSTIC
COMPETITIVE GENERIC THERAPY
12/27/2026
002
ODE-306W/ BEVACIZUMAB FOR MAINT TX OF ADULTS W/ ADV EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CA IN COMPLETE OR PARTIAL RESPONSE TO 1ST LINE PT BASED CHEMO & WHOSE CA IS ASSOC W/ HOMOLOGOUS RECOMB DEF + STATUS DEFINED BY GENOMIC INSTABILITY
COMPETITIVE GENERIC THERAPY
05/08/2027

 

 


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