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: N202811

Product 002
LINACLOTIDE (LINZESS) CAPSULE 290MCG

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
002	7304036	08/30/2026	DS	DP	U-1278 U-1516
002	7371727	01/28/2024	DS
002	7704947	01/28/2024	DS	DP
002	7745409	01/28/2024	DS	DP
002	8080526	01/28/2024	DS	DP
002	8110553	01/28/2024			U-1278
002	8748573	10/30/2031			U-1515 U-1516		06/11/2014
002	8802628	10/30/2031		DP			08/19/2014
002	8933030	02/17/2031		DP			02/06/2015
002	9708371	08/16/2033		DP	U-1515		08/10/2017

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration

 

 

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