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: N210875

Product 003
APOMORPHINE HYDROCHLORIDE (KYNMOBI) FILM 20MG

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
003 8414922 12/16/2031 DP
U-2825 TREATMENT OF 'OFF' EPISODES IN PATIENTS WITH PARKINSON'S DISEASE
06/04/2020
003 8603514 04/03/2024 DP
06/04/2020
003 8663687 02/02/2023 DP
06/04/2020
003 8765167 02/20/2024 DP
06/04/2020
003 8846074 12/16/2031 DP
U-2825 TREATMENT OF 'OFF' EPISODES IN PATIENTS WITH PARKINSON'S DISEASE
06/04/2020
003 9044475 06/11/2030 DP
06/04/2020
003 9283219 06/11/2030 DP
U-2825 TREATMENT OF 'OFF' EPISODES IN PATIENTS WITH PARKINSON'S DISEASE
06/04/2020
003 9326981 06/11/2030
U-2825 TREATMENT OF 'OFF' EPISODES IN PATIENTS WITH PARKINSON'S DISEASE
06/04/2020
003 9669019 06/11/2030 DP
U-2825 TREATMENT OF 'OFF' EPISODES IN PATIENTS WITH PARKINSON'S DISEASE
06/04/2020
003 9669021 06/11/2030
U-2825 TREATMENT OF 'OFF' EPISODES IN PATIENTS WITH PARKINSON'S DISEASE
06/04/2020
003 9855221 02/14/2022 DP
06/04/2020
003 9931305 02/14/2022 DP
06/04/2020
003 10420763 06/11/2030 DP
U-2825 TREATMENT OF 'OFF' EPISODES IN PATIENTS WITH PARKINSON'S DISEASE
06/04/2020
003 10449146 04/19/2036
U-2825 TREATMENT OF 'OFF' EPISODES IN PATIENTS WITH PARKINSON'S DISEASE
06/04/2020
003 10821074 08/07/2029 DP
11/12/2020
003 10888499 02/14/2022 DP
01/14/2021
003 10959943 04/19/2036
U-2825 TREATMENT OF 'OFF' EPISODES IN PATIENTS WITH PARKINSON'S DISEASE
04/02/2021

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
003
NPNEW PRODUCT
COMPETITIVE GENERIC THERAPY
05/21/2023

 

 


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