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: N209184

Product 001
LEVODOPA (INBRIJA) POWDER 42MG

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 6858199 11/04/2021
U-2485 INTERMITTENT TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSON'S DISEASE TREATED WITH CARBIDOPA/LEVODOPA BY INHALATION OF LEVODOPA POWDER PARTICLES THROUGH A SINGLE BREATH ACTIVATED STEP
01/18/2019
001 7146978 04/16/2021
U-2486 INTERMITTENT TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSON'S DISEASE WITH A POWDER INHALER
01/18/2019
001 7182961 02/22/2024 DP
01/18/2019
001 7384649 11/20/2022 DP
01/18/2019
001 7556798 11/04/2021
U-2485 INTERMITTENT TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSON'S DISEASE TREATED WITH CARBIDOPA/LEVODOPA BY INHALATION OF LEVODOPA POWDER PARTICLES THROUGH A SINGLE BREATH ACTIVATED STEP
01/18/2019
001 8404276 03/19/2023
U-2484 INTERMITTENT TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSON'S DISEASE TREATED WITH CARBIDOPA/LEVODOPA BY INHALATION OF LEVODOPA POWDER PARTICLES
01/18/2019
001 8545878 11/16/2032 DP
01/18/2019
001 8586093 03/19/2023
U-2484 INTERMITTENT TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSON'S DISEASE TREATED WITH CARBIDOPA/LEVODOPA BY INHALATION OF LEVODOPA POWDER PARTICLES
01/18/2019
001 8685442 11/16/2032 DP
01/18/2019
001 8945612 11/16/2032 DP
01/18/2019
001 9155699 03/19/2023 DP
01/18/2019
001 9393210 11/16/2032 DP
01/18/2019
001 RE43711 02/03/2029
U-2484 INTERMITTENT TREATMENT OF OFF EPISODES IN PATIENTS WITH PARKINSON'S DISEASE TREATED WITH CARBIDOPA/LEVODOPA BY INHALATION OF LEVODOPA POWDER PARTICLES
01/18/2019

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001
NPNEW PRODUCT
COMPETITIVE GENERIC THERAPY
12/21/2021

 

 


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