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: N208271

Product 001
METHYLNALTREXONE BROMIDE (RELISTOR) TABLET 150MG

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
001	8420663	09/30/2029			U-1185		07/25/2016
001	8524276	03/10/2031		DP			07/25/2016
001	8956651	03/10/2031		DP			07/25/2016
001	9180125	09/30/2029		DP	U-1185		07/25/2016
001	9314461	03/10/2031		DP			08/12/2016
001	9492445	09/30/2029		DP	U-1185		08/30/2017
001	9724343	09/30/2029		DP	U-1185		08/16/2017
001	10307417	03/10/2031		DP			06/07/2019
001	10376505	03/10/2031		DP			09/10/2019

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration

 

 

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