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: N210365

Product 001
CANNABIDIOL (EPIDIOLEX) SOLUTION 100MG/ML

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 9949937 06/17/2035
U-2421 USE IN COMBINATION WITH CLOBAZAM FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH DRAVET SYNDROME
10/25/2018
001 9956183 06/17/2035
U-2422 USE IN COMBINATION WITH CLOBAZAM FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH LENNOX GASTAUT SYNDROME WHO HAVE BEEN PREVIOUSLY TREATED WITH CLOBAZAM
U-2423 USE IN COMBINATION WITH CLOBAZAM FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH DRAVET SYNDROME WHO HAVE BEEN PREVIOUSLY TREATED WITH CLOBAZAM
10/25/2018
001 9956184 06/17/2035
U-2424 USE IN COMBINATION WITH CLOBAZAM FOR TREATMENT OF SEIZURES IN PATIENTS WITH LENNOX GASTAUT SYNDROME
10/25/2018
001 9956185 06/17/2035
U-2425 USE FOR THE TREATMENT OF CONVULSIVE SEIZURES IN PATIENTS WITH DRAVET SYNDROME
10/25/2018
001 9956186 06/17/2035
U-2426 USE FOR THE TREATMENT OF CONVULSIVE SEIZURES IN PATIENTS WITH LENNOX GASTAUT SYNDROME
10/25/2018
001 10092525 06/17/2035
U-2427 USE FOR THE TREATMENT OF DROP SEIZURES IN PATIENTS WITH DRAVET SYNDROME
10/25/2018
001 10111840 06/17/2035
U-2442 USE FOR THE TREATMENT OF ATONIC SEIZURES IN PATIENTS WITH LENNOX-GASTAUT SYNDROME
U-2443 USE FOR THE TREATMENT OF ATONIC SEIZURES IN PATIENTS WITH DRAVET SYNDROME
11/27/2018
001 10137095 06/17/2035
U-2454 USE FOR THE TREATMENT OF DROP SEIZURES IN PATIENTS WITH LENNOX-GASTAUT SYNDROME
U-2455 USE IN COMBINATION WITH CLOBAZAM FOR TREATMENT OF DROP SEIZURES IN PATIENTS WITH LENNOX GASTAUT SYNDROME
12/17/2018
001 10195159 05/07/2022 DS
06/26/2019
001 10603288 06/17/2035
U-2780 USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH LENNOX-GASTAUT SYNDROME
U-2781 USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH DRAVET SYNDROME
U-2782 USE FOR REDUCING CONVULSIVE SEIZURE FREQUENCY IN PATIENTS WITH LENNOX GASTAUT SYNDROME
U-2783 USE FOR REDUCING CONVULSIVE SEIZURE FREQUENCY IN PATIENTS WITH DRAVET SYNDROME
04/27/2020
001 10709671 06/17/2035
U-2862 USE FOR THE TREATMENT OF FOCAL SEIZURES IN PATIENTS WITH DRAVET SYNDROME
07/30/2020
001 10709673 06/17/2035 DP
07/30/2020
001 10709674 06/17/2035
U-2780 USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH LENNOX-GASTAUT SYNDROME
U-2781 USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH DRAVET SYNDROME
07/30/2020
001 10849860 06/17/2035
U-2427 USE FOR THE TREATMENT OF DROP SEIZURES IN PATIENTS WITH DRAVET SYNDROME
U-2454 USE FOR THE TREATMENT OF DROP SEIZURES IN PATIENTS WITH LENNOX-GASTAUT SYNDROME
11/18/2020
001 10918608 10/14/2035
U-3071 USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH TUBEROUS SCLEROSIS COMPLEX
U-3072 USE FOR THE TREATMENT OF GENERALIZED SEIZURES OR FOCAL SEIZURES WITH IMPAIRMENT IN PATIENTS WITH TUBEROUS SCLEROSIS COMPLEX
U-3073 USE FOR REDUCING SEIZURE FREQUENCY IN PATIENTS WITH TUBEROUS SCLEROSIS COMPLEX
02/26/2021
001 10966939 06/17/2035 DP
U-2780 USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH LENNOX-GASTAUT SYNDROME
U-2781 USE FOR THE TREATMENT OF SEIZURES IN PATIENTS WITH DRAVET SYNDROME
04/30/2021

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001
NPPNEW PATIENT POPULATION
COMPETITIVE GENERIC THERAPY
07/31/2023
001
NCENEW CHEMICAL ENTITY
COMPETITIVE GENERIC THERAPY
09/28/2023
001
ODE-216INDICATED FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME (LGS) OR DRAVET SYNDROME (DS) IN PATIENTS 2 YEARS OF AGE AND OLDER
COMPETITIVE GENERIC THERAPY
09/28/2025
001
ODE-326TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME (LGS) OR DRAVET SYNDROME (DS) IN PATIENTS BETWEEN 1 AND 2 YEARS OF AGE
COMPETITIVE GENERIC THERAPY
07/31/2027
001
ODE-332TREATMENT OF SEIZURES ASSOCIATED WITH TUBEROUS SCLEROSIS COMPLEX (TSC) IN PATIENTS 1 YEAR OF AGE AND OLDER
COMPETITIVE GENERIC THERAPY
07/31/2027

 

 


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