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 001
TELAVANCIN HYDROCHLORIDE (VIBATIV) POWDER EQ 250MG BASE/VIAL

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 6635618 09/11/2023 DS DP
U-728 METHOD FOR TREATING BACTERIAL INFECTION
001 6858584 08/24/2022 DP
001 6872701 06/05/2021 DP
001 7008923 05/06/2021
U-1005 METHOD OF TREATING A STAPHYLOCOCCAL INFECTION
001 7208471 05/01/2021 DS DP
001 7351691 05/01/2021 DS DP
U-728 METHOD FOR TREATING BACTERIAL INFECTION
001 7531623 01/01/2027 DS
001 7544364 05/01/2021 DP
001 7700550 05/01/2021
U-282 METHOD OF TREATING BACTERIAL INFECTIONS
001 8101575 05/01/2021 DP
001 8158580 05/01/2021 DP
04/25/2012

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration

 

 


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