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: N206089

Product 003
TESTOSTERONE UNDECANOATE (JATENZO) CAPSULE 237MG

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
003	8241664	03/29/2029		DP	U-2506		04/08/2019
003	8492369	12/20/2030		DP	U-2506		04/08/2019
003	8778916	04/12/2030		DP			04/08/2019
003	10543219	04/12/2030			U-2506		02/18/2020
003	10617696	04/12/2030	DS	DP			05/05/2020
003	11179402	04/14/2026	DS	DP			12/21/2021
003	11179403	04/12/2030			U-2506		12/21/2021
003	11331325	01/06/2027			U-2506		06/02/2022
003	11426416	04/12/2030			U-3420		09/12/2022
003	11564933	04/12/2039			U-1103		02/10/2023

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration

 

 

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