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: N211230

Product 001
SOLRIAMFETOL HYDROCHLORIDE (SUNOSI) TABLET EQ 75MG BASE

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
001	8440715	06/11/2031			U-2548		06/24/2019
001	8877806	06/07/2026			U-2548		06/24/2019
001	9604917	06/07/2026			U-2548		06/24/2019
001	10195151	09/05/2037		DP			06/24/2019
001	10351517	06/07/2026			U-2548		08/16/2019
001	10512609	09/05/2037			U-2548		01/22/2020
001	10912754	06/01/2038			U-3082		03/10/2021
001	10940133	03/19/2040			U-3099		04/07/2021
001	10959976	06/01/2038			U-3151		04/27/2021
001	11160779	03/19/2040			U-3521		02/13/2023
001	11439597	09/05/2037		DP			10/13/2022
001	11560354	03/06/2039		DP	U-3520		02/13/2023
001	11648232	06/01/2038			U-3602		05/26/2023
001	11753368	06/07/2026			U-2548		09/14/2023
001	11771666	12/30/2042			U-3693		10/06/2023
001	11771667	12/30/2042			U-3693		10/06/2023
001	11779554	12/30/2042			U-3693		10/12/2023
001	11793776	12/30/2042			U-3693		10/27/2023
001	11839598	03/19/2040			U-3765		12/15/2023
001	11839599	03/19/2040			U-3764		12/15/2023
001	11850226	03/19/2040			U-3775		12/29/2023
001	11850227	03/19/2040			U-3775		12/29/2023
001	11850228	03/19/2040			U-3775		12/29/2023
001	11857528	03/19/2040			U-3521		01/19/2024
001	11865098	06/01/2038			U-2548		02/08/2024
001	11872203	12/30/2042			U-3693		01/19/2024
001	11872204	12/30/2042			U-3693		01/19/2024
001	11969404	03/19/2040			U-3892		05/02/2024

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration
001	NCE	06/17/2024
001	ODE-254	06/17/2026

 

 

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