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: N207356

Product 001
AMIKACIN SULFATE (ARIKAYCE KIT) SUSPENSION, LIPOSOMAL EQ 590MG BASE/8.4ML

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 7718189 06/06/2025 DP
U-2415 TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION ANTIBACTERIAL DRUG REGIMEN
10/24/2018
001 8226975 08/15/2028 DP
10/24/2018
001 8632804 12/05/2026
U-2416 TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS WITH CYSTIC FIBROSIS AS PART OF A COMBINATION DRUG REGIMEN
10/24/2018
001 8642075 12/05/2026 DP
10/24/2018
001 8679532 12/05/2026
U-2415 TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION ANTIBACTERIAL DRUG REGIMEN
10/24/2018
001 8802137 04/08/2024 DP
U-2414 TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION DRUG REGIMEN
10/24/2018
001 9566234 01/18/2034 DP
U-2415 TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION ANTIBACTERIAL DRUG REGIMEN
10/24/2018
001 9827317 04/08/2024 DP
U-2415 TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION ANTIBACTERIAL DRUG REGIMEN
10/24/2018
001 9895385 05/15/2035
U-2417 TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN NON-CYSTIC FIBROSIS ADULTS AS PART OF A COMBINATION ANTIBACTERIAL DRUG REGIMEN
10/24/2018
001 10251900 05/15/2035
U-2414 TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION DRUG REGIMEN
05/02/2019
001 10751355 05/15/2035
U-2414 TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION DRUG REGIMEN
09/24/2020

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001
ODE-214TX OF MAC LUNG DISEASE IN ADULTS WITH LIMITED OR NO ALTERNATIVE TX OPTIONS AS PART OF A COMBO ANTIBACTERIAL DRUG REGIMEN WHO DO NOT ACHIEVE NEGATIVE SPUTUM CULTURES AFTER A MINIMUM OF 6 CONSECUTIVE MONTHS OF A MULTIDRUG BACKGROUND REGIMEN THERAPY
COMPETITIVE GENERIC THERAPY
09/28/2025
001
ODE-214TX OF MAC LUNG DISEASE IN ADULTS WITH LIMITED OR NO ALTERNATIVE TX OPTIONS AS PART OF A COMBO ANTIBACTERIAL DRUG REGIMEN WHO DO NOT ACHIEVE NEGATIVE SPUTUM CULTURES AFTER A MINIMUM OF 6 CONSECUTIVE MONTHS OF A MULTIDRUG BACKGROUND REGIMEN THERAPY
*GAIN GENERATING ANTIBIOTIC INCENTIVES NOW
09/28/2030

 

 


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