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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: N020866

Product 001
BROMOCRIPTINE MESYLATE (CYCLOSET) TABLET EQ 0.8MG BASE

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 8431155 04/30/2032 DP U-976 05/02/2013
001 8613947 04/30/2032 DP U-976 02/03/2014
001 8877708 06/07/2030 DP U-1706 06/18/2015
001 9192576 04/30/2032 DP U-976 02/09/2016
001 9352025 06/07/2030 U-2111 U-2112 U-2113 U-2114 U-2115 U-2116 U-2117 U-2118 U-2119 09/27/2017
001 9522117 04/30/2032 DP U-976 U-1939 01/18/2017
001 9700555 04/30/2032 DP U-2183 U-2184 U-2185 U-2186 U-2187 U-2188 U-2189 U-2190 U-2191 U-2192 U-2193 U-2194 U-2195 U-2196 U-2197 U-2198 12/18/2017
001 9895422 06/07/2030 U-2114 U-2116 U-2281 U-2282 U-2283 U-2284 U-2285 U-2286 U-2287 05/07/2018
001 9993474 04/30/2032 U-2384 U-2385 U-2386 U-2387 U-2388 U-2389 U-2390 U-2391 U-2392 U-2393 09/12/2018
001 10688094 04/30/2032 U-2870 U-2871 U-2872 U-2873 U-2874 U-2875 U-2876 U-2877 U-2878 U-2879 U-2880 U-2881 U-2882 U-2883 U-2884 U-2885 U-2886 U-2887 U-2888 08/11/2020
001 10688155 06/07/2030 U-2281 U-2890 U-2891 U-2892 U-2893 U-2894 U-2895 U-2896 U-2897 U-2898 U-2899 U-2900 U-2901 U-2902 U-2903 U-2904 U-2905 U-2906 U-2907 U-2908 U-2909 U-2910 U-2911 U-2912 U-2913 U-2914 U-2915 U-2916 U-2917 U-2918 U-2919 U-2920 U-2921 U-2922 U-2923 U-2924 U-2925 U-2926 U-2927 U-2928 U-2929 U-2930 U-2931 U-2932 U-2933 U-2934 U-2935 U-2936 U-2937 08/18/2020
001 11000522 04/30/2032 U-3119 U-3120 U-3121 U-3122 06/03/2021

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration

 

 


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