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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: N022321

Product 002
MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE (EMBEDA) CAPSULE, EXTENDED RELEASE 30MG;1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
002 7682633 06/19/2027 U-1510
002 7682634 06/19/2027 DP
002 7815934 12/12/2027 DP
002 8158156 06/19/2027 U-1510
002 8623418 11/07/2029 U-1640 01/22/2015
002 8685443 07/03/2025 U-1508
002 8685444 07/03/2025 DP
002 8846104 06/19/2027 DP 10/28/2014
002 8877247 06/19/2027 DP 12/01/2014

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration



View a list of all patent use codes
View a list of all exclusivity codes

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