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: N213138

Product 001
FIDAXOMICIN (DIFICID) FOR SUSPENSION 40MG/ML

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
001	7378508	07/31/2027	DS	DP			02/21/2020
001	7378508*PED	01/31/2028
001	7863249	07/31/2027		DP			02/21/2020
001	7863249*PED	01/31/2028
001	7906489	03/04/2027			U-2741		02/21/2020
001	7906489*PED	09/04/2027
001	8586551*PED	01/15/2024
001	8859510	07/31/2027			U-2741		02/21/2020
001	8859510*PED	01/31/2028
001	9808530	05/28/2034		DP			02/21/2020
001	9808530*PED	11/28/2034

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration
001	ODE-367	01/24/2027

 

 

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