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(EMBEDA) CAPSULE, EXTENDED RELEASE 30MG;1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

 

 

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