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: N022225

Product 002
SUGAMMADEX SODIUM (BRIDION) SOLUTION EQ 200MG BASE/2ML (EQ 100MG BASE/ML)

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
002 6949527 01/27/2021
U-1795 REVERSAL OF NEUROMUSCULAR BLOCKAGE INDUCED BY ROCURONIUM BROMIDE OR VECURONIUM BROMIDE
01/12/2016
002 RE44733 01/27/2026 DS DP
U-1794 REVERSAL OF DRUG-INDUCED NEUROMUSCULAR BLOCK
01/12/2016

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
002
M-262REVISIONS TO THE USE IN SPECIFIC POPULATIONS SECTION OF THE PACKAGE INSERT TO INCLUDE THE RESULT OF STUDY P146 TO FULFILL THE REQUIREMENTS OF PMR 3003-4
COMPETITIVE GENERIC THERAPY
06/09/2023

 

 


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