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: N022512

Product 002
DABIGATRAN ETEXILATE MESYLATE (PRADAXA) CAPSULE EQ 150MG BASE

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
002 6087380 12/28/2021 DS DP
U-1931 PROPHYLAXIS OR TREATMENT OF VENOUS AND ARTERIAL THROMBOTIC DISEASE
002 7866474 08/31/2027 DP
Y 08/01/2011
002 7932273 09/07/2025 DS DP
002 9034822 01/20/2031
U-1759 METHOD OF REVERSING THE ANTICOAGULANT EFFECT OF DABIGATRAN USING IDARUCIZUMAB
11/09/2015
002 9925174 06/14/2023 DP
04/12/2018

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration

 

 


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