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: N022272

Product 001
OXYCODONE HYDROCHLORIDE (OXYCONTIN) TABLET, EXTENDED RELEASE 10MG

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 7674799 03/30/2025 DP
Y
001 7674800 03/30/2025 DS
Y
001 7683072 03/30/2025 DS
Y
001 7776314 04/19/2025 DP
Y
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
11/14/2012
001 8808741 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
08/19/2014
001 8894987 03/29/2030 DP
11/25/2014
001 8894988 08/24/2027 DP
11/25/2014
001 9073933 03/30/2025 DS
08/03/2015
001 9492389 08/24/2027 DP
11/16/2016
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
11/16/2016
001 9492392 08/24/2027 DP
11/16/2016
001 9492393 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
11/16/2016
001 9522919 03/30/2025 DS DP
12/20/2016
001 9675610 06/16/2023 DP
07/12/2017
001 9763933 08/24/2027 DP
09/19/2017
001 9770416 08/24/2027 DP
09/27/2017
001 9775808 08/24/2027 DP
10/04/2017
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
001 10407434 03/30/2025 DS
09/10/2019
001 10675278 11/20/2023 DP
06/10/2020
001 10696684 03/30/2025 DS
06/30/2020

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration

 

 


View a list of all patent use codes
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