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: N022496

Product 002
BUPIVACAINE (EXPAREL) INJECTABLE, LIPOSOMAL 266MG/20ML (13.3MG/ML)

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
002	11033495	01/22/2041		DP	U-3182		07/30/2021
002	11179336	01/22/2041		DP	U-3250		11/30/2021
002	11278494	01/22/2041		DP	U-3250		04/04/2022
002	11304904	01/22/2041		DP	U-3346		04/21/2022
002	11311486	01/22/2041		DP	U-3250		04/27/2022
002	11357727	01/22/2041		DP	U-3380		06/16/2022
002	11426348	01/22/2041		DP	U-3380		09/02/2022
002	11452691	01/22/2041		DP	U-3439		10/04/2022
002	11819574	01/22/2041		DP	U-3250		12/06/2023
002	11819575	01/22/2041		DP	U-3250		12/06/2023
002	11918565	02/02/2043			U-3841		03/20/2024
002	11925706	01/22/2041		DP	U-3380		03/15/2024
002	11931459	03/17/2042			U-3839 U-3840		03/20/2024

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration
002	NPP	03/22/2024
002	I-929	11/09/2026

 

 

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