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: N208399

Product 001
ROLAPITANT HYDROCHLORIDE (VARUBI) EMULSION EQ 166.5MG BASE/92.5ML (EQ 1.8MG BASE/ML)

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
001	7049320	08/19/2028	DS	DP	U-1741		11/16/2017
001	7981905	04/04/2027			U-1741		11/22/2017
001	8178550	04/04/2027	DS	DP			11/22/2017
001	8404702	04/04/2027			U-1741		11/22/2017
001	8470842	01/18/2029			U-1741		11/22/2017
001	9101615	07/14/2032			U-1741		11/22/2017

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration

 

 

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