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: N205677

Product 001
TASIMELTEON (HETLIOZ) CAPSULE 20MG

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
001	9060995	01/25/2033			U-1710		06/26/2015
001	9539234	01/25/2033			U-1934 U-3004		01/11/2017
001	9549913	01/25/2033			U-1486		01/27/2017
001	9730910	05/17/2034			U-2085 U-3005		08/22/2017
001	9855241	01/25/2033			U-2149		01/18/2018
001	10071977	02/12/2035	DS	DP			09/17/2018
001	10149829	01/25/2033			U-2477 U-3006		12/27/2018
001	10179119	08/29/2035			U-3003		12/21/2020
001	10376487	07/27/2035			U-2615 U-3007		09/11/2019
001	10449176	01/25/2033			U-2149		11/20/2019
001	10610510	01/25/2033			U-2805 U-3009		05/08/2020
001	10610511	10/10/2034			U-2615 U-3007		05/08/2020
001	10829465	02/12/2035	DS	DP			11/17/2020
001	10945988	01/25/2033			U-2149		03/25/2021
001	10980770	01/25/2033			U-3106 U-3107		04/15/2021
001	11141400	10/10/2034			U-2615 U-3007		10/25/2021
001	11266622	08/29/2035			U-3003		06/14/2022
001	11285129	01/25/2033			U-3342 U-3343		04/15/2022
001	11566011	02/12/2035	DS	DP			02/15/2023
001	11633377	01/25/2033			U-2149 U-3003		04/27/2023
001	11759446	02/21/2041			U-3003		10/13/2023
001	11760740	02/12/2035	DS	DP			10/13/2023
001	11786502	10/10/2034			U-3007 U-3739		11/13/2023
001	11826339	01/25/2033			U-3342 U-3343		04/04/2024
001	11833130	01/25/2033			U-2149 U-3003		01/03/2024
001	11850229	01/25/2033			U-3342 U-3343		01/03/2024
001	11918556	01/25/2033			U-3342 U-3343		04/04/2024
001	11918557	04/07/2033			U-3003 U-3865		04/04/2024
001	RE46604	01/25/2033			U-2147		11/30/2017

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration
001	ODE-330	12/01/2027

 

 

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