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: N206627

Product 001
HYDROCODONE BITARTRATE (HYSINGLA ER) TABLET, EXTENDED RELEASE 20MG

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 6733783 10/30/2021 DP
U-1556 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
11/21/2014
001 8309060 11/20/2023 DP
U-1556 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
11/21/2014
001 8361499 10/30/2021 DP
11/21/2014
001 8529948 08/06/2022 DP
11/21/2014
001 8551520 10/30/2021 DP
11/21/2014
001 8647667 10/30/2021 DP
11/21/2014
001 8808740 12/21/2031 DP
U-1556 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
11/21/2014
001 9023401 10/30/2020 DP
05/22/2015
001 9056052 10/30/2020 DP
07/13/2015
001 9060940 10/30/2020
U-1556 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
07/17/2015
001 9084816 08/24/2027 DP
07/21/2015
001 9095614 08/24/2027
U-1556 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
08/04/2015
001 9095615 08/24/2027 DP
08/04/2015
001 9198863 10/30/2020 DP
12/24/2015
001 9205056 10/30/2020 DP
12/24/2015
001 9289391 10/30/2020 DP
04/19/2016
001 9486412 08/24/2027 DP
11/08/2016
001 9486413 08/24/2027 DP
11/08/2016
001 9492389 08/24/2027 DP
11/16/2016
001 9492390 08/24/2027
U-1556 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
11/17/2016
001 9492391 08/24/2027
U-1556 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
11/17/2016
001 9517236 10/30/2020 DP
02/09/2017
001 9545380 08/24/2027
U-1556 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
01/17/2017
001 9572779 12/21/2031 DP
02/21/2017
001 9572804 10/30/2020 DP
03/22/2017
001 9669023 10/30/2020 DP
06/06/2017
001 9669024 10/30/2020 DP
06/06/2017
001 9675610 06/16/2023 DP
07/12/2017
001 9675611 10/30/2020
U-1556 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
06/20/2017
001 9682077 10/30/2020
U-1556 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
06/20/2017
001 9750703 12/21/2031 DP
09/14/2017
001 9763933 08/24/2027 DP
09/19/2017
001 9770416 08/24/2027 DP
09/27/2017
001 9775809 08/24/2027 DP
10/04/2017
001 9861584 12/21/2031 DP
01/10/2018
001 9872837 12/21/2031 DP
01/23/2018
001 10130591 11/20/2023 DP
U-1819 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
11/27/2018
001 10369109 06/16/2023 DP
08/09/2019

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration

 

 


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