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: N210491

Product 002
IVACAFTOR; IVACAFTOR, TEZACAFTOR (SYMDEKO (COPACKAGED)) TABLET 75MG;75MG, 50MG

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
002	7495103	05/20/2027	DS	DP			07/17/2019
002	7645789	05/01/2027	DS	DP			07/17/2019
002	7776905	06/03/2027	DS	DP			07/17/2019
002	8324242	08/05/2027			U-2246		07/17/2019
002	8354427	07/06/2026			U-3021		01/14/2021
002	8410274	12/28/2026		DP			07/17/2019
002	8415387	11/12/2027			U-2246		07/17/2019
002	8598181	05/01/2027			U-2246		07/17/2019
002	8623905	05/01/2027	DS	DP			07/17/2019
002	8629162	06/24/2025			U-2247		07/17/2019
002	8754224	12/28/2026	DS	DP			07/17/2019
002	9012496	07/15/2033			U-2248		07/17/2019
002	9670163	12/28/2026		DP	U-2246		07/17/2019
002	9931334	12/28/2026		DP	U-2275 U-2575		07/17/2019
002	9974781	04/09/2027		DP	U-2318 U-2574		07/17/2019
002	10022352	04/09/2027		DP	U-2343 U-2573		07/17/2019
002	10058546	07/15/2033			U-2399 U-2572 U-3022 U-3023		07/17/2019
002	10081621	03/25/2031		DP	U-2420 U-2571 U-3024 U-3025		07/17/2019
002	10206877	04/14/2035		DP	U-2498 U-2570 U-3026 U-3027		07/17/2019
002	10239867	04/09/2027	DS	DP	U-2512 U-2569		07/17/2019
002	10646481	08/13/2029		DP			06/08/2020
002	11564916	08/13/2029			U-3527		02/28/2023
002	11578062	03/25/2031		DP	U-3545		03/16/2023
002	11639347	04/09/2027	DS	DP	U-2569		05/22/2023

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration
002	ODE-173	02/12/2025
002	ODE-247	06/21/2026
002	ODE-335	12/21/2027

 

 

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