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: N204031

Product 001
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE (XARTEMIS XR) TABLET, EXTENDED RELEASE 325MG;7.5MG

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 7976870 06/01/2027
U-1498 METHOD OF TREATING PATIENTS WITH GASTRIC RETENTIVE DOSAGE FORM
04/03/2014
001 8372432 03/11/2029 DP
U-1499 MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
04/03/2014
001 8377453 11/19/2029 DP
U-1499 MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
04/03/2014
001 8394408 03/11/2029 DP
04/03/2014
001 8597681 12/21/2030 DP
04/03/2014
001 8658631 05/16/2032 DP
04/03/2014
001 8668929 03/11/2029
U-1499 MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
04/03/2014
001 8741885 05/16/2032 DP
U-1499 MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
06/17/2014
001 8980319 12/21/2030 DP
04/03/2015
001 8992975 05/16/2032 DP
04/03/2015
001 9050335 05/16/2032 DP
06/25/2015
001 9468636 05/16/2032
U-1499 MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
11/16/2016

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration

 

 


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