Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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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.

Patent and Exclusivity for: N212725

Product 001
ENTRECTINIB (ROZLYTREK) CAPSULE 100MG

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 8299057 03/01/2029 DS DP
09/13/2019
001 8673893 07/08/2028
U-2617 TREATMENT OF ROS1-POSITIVE NON-SMALL CELL LUNG CANCER
U-2618 TREATMENT OF SOLID TUMORS THAT HAVE A NEUROTROPHIC TYROSINE RECEPTOR KINASE (NTRK) GENE FUSION
09/13/2019
001 9029356 07/08/2028 DS DP
09/13/2019
001 9085558 07/08/2028 DP
09/13/2019
001 9085565 05/22/2033 DS DP
09/13/2019
001 9255087 07/08/2028
U-2617 TREATMENT OF ROS1-POSITIVE NON-SMALL CELL LUNG CANCER
U-2618 TREATMENT OF SOLID TUMORS THAT HAVE A NEUROTROPHIC TYROSINE RECEPTOR KINASE (NTRK) GENE FUSION
09/13/2019
001 9616059 07/08/2028
U-2618 TREATMENT OF SOLID TUMORS THAT HAVE A NEUROTROPHIC TYROSINE RECEPTOR KINASE (NTRK) GENE FUSION
09/13/2019
001 9649306 05/22/2033
U-2617 TREATMENT OF ROS1-POSITIVE NON-SMALL CELL LUNG CANCER
U-2618 TREATMENT OF SOLID TUMORS THAT HAVE A NEUROTROPHIC TYROSINE RECEPTOR KINASE (NTRK) GENE FUSION
09/13/2019
001 10231965 02/17/2035
U-2617 TREATMENT OF ROS1-POSITIVE NON-SMALL CELL LUNG CANCER
U-2618 TREATMENT OF SOLID TUMORS THAT HAVE A NEUROTROPHIC TYROSINE RECEPTOR KINASE (NTRK) GENE FUSION
09/13/2019
001 10398693 07/18/2038 DP
09/13/2019
001 10561651 02/19/2035
U-2745 TREATMENT OF NEUROBLASTOMAS THAT HAVE A NEUROTROPHIC TYROSINE RECEPTOR KINASE (NTRK) GENE FUSION
03/13/2020
001 10738037 05/18/2037 DS DP
U-2946 TREATMENT OF COLORECTAL CANCER THAT HAS A NEUROTROPHIC TYROSINE RECEPTOR KINASE(NTRK) GENE FUSION
09/09/2020

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001
NCENEW CHEMICAL ENTITY
COMPETITIVE GENERIC THERAPY
08/15/2024
001
ODE-265INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS ARE ROS1-POSITIVE
COMPETITIVE GENERIC THERAPY
08/15/2026
001
ODE-313INDICATED FOR THE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH SOLID TUMORS THAT HAVE A NEUROTROPHIC TYROSINE RECEPTOR KINASE (NTRK) GENE FUSION WITHOUT A KNOWN ACQUIRED RESISTENACE MUTATION, ARE METASTATIC OR WHERE SURGICAL RESECTION IS LIKELY TO RESULT IN SEVERE MORBIDITY, AND HAVE EITHER PROGRESSED FOLLOWING TREATMENT OR HAVE NO SATISFACTORY ALTERNATIVE THERAPY
COMPETITIVE GENERIC THERAPY
08/15/2026

 

 


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