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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: N202057

Product 001
ICOSAPENT ETHYL (VASCEPA) CAPSULE 1GM

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 8293727 02/09/2030 U-1287
001 8293728 02/09/2030 U-1287
001 8298554 04/29/2030 DP
001 8314086 02/09/2030 U-1287
001 8318715 02/09/2030 U-1287 11/29/2012
001 8357677 02/09/2030 U-1287
001 8367652 02/09/2030 U-1287 02/07/2013
001 8377920 02/09/2030 U-1287
001 8399446 02/09/2030 U-1287 04/17/2013
001 8410086 06/15/2030 U-2688 01/06/2020
001 8415335 02/09/2030 U-1287 04/17/2013
001 8426399 02/09/2030 U-1287
001 8431560 02/09/2030 U-1287
001 8440650 02/09/2030 U-1287
001 8445003 04/29/2030 U-1287
001 8445013 04/29/2030 U-1287
001 8454994 04/29/2030 U-2689 01/06/2020
001 8455472 06/15/2030 U-2690 01/06/2020
001 8501225 04/29/2030 U-1287
001 8518929 02/09/2030 U-1287
001 8524698 02/09/2030 U-1287 09/11/2013
001 8546372 02/09/2030 U-1287 10/01/2013
001 8551521 04/29/2030 U-1287 10/09/2013
001 8563608 04/29/2030 U-1287 10/22/2013
001 8617593 04/29/2030 U-1478 U-2691 01/14/2014
001 8617594 04/29/2030 U-1287
001 8618166 04/29/2030 U-2689 01/06/2020
001 8623406 04/29/2030 U-1478 U-2692 01/14/2014
001 8642077 04/29/2030 U-2693 01/06/2020
001 8669245 06/15/2030 U-2694 01/06/2020
001 8680144 02/09/2030 U-2695 01/06/2020
001 8691871 04/29/2030 U-2689 01/06/2020
001 8703185 04/29/2030 U-2691 01/06/2020
001 8709475 04/29/2030 U-2689 01/06/2020
001 8710041 06/15/2030 U-2690 01/06/2020
001 9198892 09/25/2027 U-2706 01/10/2020
001 9603826 06/28/2033 U-2696 01/06/2020
001 9610272 06/28/2033 U-2697 01/06/2020
001 9623001 06/28/2033 U-2698 01/06/2020
001 9693984 06/28/2033 U-2697 01/06/2020
001 9693985 06/28/2033 U-2696 01/06/2020
001 9693986 06/28/2033 U-2698 01/06/2020
001 9700537 05/31/2027 U-2707 01/10/2020
001 9918954 06/28/2033 U-2699 01/06/2020
001 10010517 04/29/2030 U-2690 01/06/2020
001 10265287 04/29/2030 U-2700 01/06/2020
001 10278935 06/28/2033 U-2701 01/06/2020
001 10278936 06/28/2033 U-2702 01/06/2020
001 10278937 06/28/2033 U-2703 01/06/2020
001 10383840 06/28/2033 U-2704 01/06/2020
001 10555924 06/28/2033 U-2743 02/26/2020
001 10555925 06/28/2033 U-2744 02/26/2020
001 10568861 06/28/2033 U-2756 03/20/2020
001 10576054 06/28/2033 U-2762 03/27/2020
001 10668042 06/28/2033 U-2841 06/26/2020
001 10786478 06/28/2033 U-2959 U-2960 10/16/2020
001 10792267 04/29/2030 U-2961 10/16/2020
001 10792270 06/28/2033 U-2962 10/16/2020
001 10842766 04/29/2030 U-2997 12/11/2020
001 10842768 06/15/2030 U-2688 12/11/2020
001 10881632 04/29/2030 U-3052 02/04/2021
001 10894028 06/28/2033 U-3053 02/04/2021
001 11000499 06/28/2033 U-3126 06/10/2021
001 11103477 04/29/2030 U-3209 09/21/2021
001 11116742 06/28/2033 U-3221 10/08/2021
001 11154526 04/29/2030 U-3240 11/08/2021
001 11213504 04/29/2030 U-3292 02/03/2022
001 11298333 06/28/2033 U-3358 05/11/2022
001 11369582 06/28/2033 U-2841 07/28/2022

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001 I-819 12/13/2022

 

 


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