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: N204384

Product 001
BEDAQUILINE FUMARATE (SIRTURO) TABLET EQ 100MG BASE

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 7498343 12/01/2026 DS DP
U-1321 TREATMENT OF PULMONARY MULTI-DRUG RESISTANT TUBERCULOSIS
01/24/2013
001 8546428 03/19/2029 DS DP
U-1321 TREATMENT OF PULMONARY MULTI-DRUG RESISTANT TUBERCULOSIS
03/14/2014

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001
NPPNEW PATIENT POPULATION
COMPETITIVE GENERIC THERAPY
08/09/2022
001
ODE-251INDICATED AS PART OF COMBINATION THERAPY IN THE TREATMENT OF PEDIATRIC PATIENTS (12 TO LESS THAN 18 YEARS OF AGE AND WEIGHING AT LEAST 30 KG) WITH PULMONARY MULTI-DRUG RESISTANT TUBERCULOSIS
COMPETITIVE GENERIC THERAPY
08/09/2026

 

 


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