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: N022110

Product 002
TELAVANCIN HYDROCHLORIDE (VIBATIV) POWDER EQ 750MG BASE/VIAL

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
002 6635618 09/11/2023 DS DP
U-728 METHOD FOR TREATING BACTERIAL INFECTION
002 6858584 08/24/2022 DP
002 6872701 06/05/2021 DP
002 7008923 05/06/2021
U-1005 METHOD OF TREATING A STAPHYLOCOCCAL INFECTION
002 7208471 05/01/2021 DS DP
002 7351691 05/01/2021 DS DP
U-728 METHOD FOR TREATING BACTERIAL INFECTION
002 7531623 01/01/2027 DS
002 7544364 05/01/2021 DP
002 7700550 05/01/2021
U-282 METHOD OF TREATING BACTERIAL INFECTIONS
002 8101575 05/01/2021 DP
002 8158580 05/01/2021 DP

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration

 

 


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