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: N209884

Product 001
SIPONIMOD (MAYZENT) TABLET EQ 0.25MG BASE

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
001	7939519	08/27/2028	DS	DP			04/19/2019
001	8492441	11/30/2030			U-2511		04/19/2019
001	11944602	07/24/2036			U-3889		04/30/2024

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration
001	NCE	03/26/2024
001	M-274	03/01/2025

 

 

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