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: N208462

Product 003
IXAZOMIB CITRATE (NINLARO) CAPSULE EQ 4MG BASE

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
003	7442830	11/20/2029	DS	DP	U-2434		12/14/2015
003	7687662	08/06/2027	DS	DP			12/14/2015
003	8003819	08/06/2027	DS	DP	U-2434		12/14/2015
003	8530694	08/06/2027	DS	DP	U-2434		12/14/2015
003	8546608	08/12/2024	DS				12/14/2015
003	8859504	06/16/2029	DS	DP			12/14/2015
003	8871745	08/06/2027			U-2434		12/14/2015
003	9175017	06/16/2029			U-2434		12/14/2015
003	9233115	08/12/2024			U-2434		02/08/2016

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration

 

 

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