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: N022030

Product 002
FESOTERODINE FUMARATE (TOVIAZ) TABLET, EXTENDED RELEASE 8MG

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
002	7807715	06/07/2027		DP	U-913
002	7807715*PED	12/07/2027
002	8088398	06/07/2027		DP	U-913
002	8088398*PED	12/07/2027
002	8501723	06/07/2027		DP			08/20/2013
002	8501723*PED	12/07/2027

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration
002	I-861	06/17/2024
002	I-861 *PED	12/17/2024

 

 

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View a list of all exclusivity codes