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: N217785

Product 001
RESMETIROM (REZDIFFRA) TABLET 60MG

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
001	7452882	09/12/2027	DS	DP			04/03/2024
001	9266861	09/17/2033	DS	DP			04/03/2024
001	10376517	09/17/2033			U-3861		04/03/2024
001	11564926	09/17/2033	DS	DP	U-3861		04/03/2024
001	11986481	09/17/2033			U-3861		06/05/2024
001	12661359	01/28/2042			U-4568		07/13/2026
001	12667575	02/04/2045			U-4567		07/13/2026

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration
001	NCE	03/14/2029

 

 

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