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: N208088

Product 001
TESTOSTERONE UNDECANOATE (TLANDO) CAPSULE 112.5MG

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
001	8778922	01/08/2029		DP	U-1500		04/27/2022
001	8865695	01/08/2029			U-1500		04/27/2022
001	9943527	11/30/2030			U-1500		04/27/2022
001	9949985	11/30/2030			U-1500		04/27/2022
001	10226473	11/30/2030			U-1500		04/27/2022
001	10716794	11/30/2030			U-1500		04/27/2022
001	11304960	01/08/2029		DP	U-1500		04/27/2022
001	11311555	11/30/2030			U-1500		05/26/2022
001	11364249	11/30/2030			U-1500		07/19/2022
001	11433083	11/30/2030			U-1500		10/06/2022
001	11464735	04/28/2041		DP	U-1500		11/10/2022
001	11559530	11/28/2037			U-1500		02/14/2023

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration
001	NP	03/28/2025

 

 

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