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: N022406

Product 004
RIVAROXABAN (XARELTO) TABLET 2.5MG

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
004 7157456 08/28/2024 DS DP
11/08/2018
004 7157456*PED 02/28/2025
004 9415053 11/13/2024 DP
U-2435 REDUCTION OF RISK OF MAJOR CARDIOVASCULAR EVENTS (CV DEATH, MI, AND STROKE) IN CHRONIC CAD OR PAD
U-3205 REDUCTION OF RISK OF MAJOR CARDIOVASCULAR EVENTS (CARDIOVASCULAR DEATH, MYOCARDIAL INFARCTION AND STROKE) IN PATIENTS WITH CAD
U-3206 REDUCTION OF RISK OF MAJOR THROMBOTIC VASCULAR EVENTS (MYOCARDIAL INFARCTION, ISCHEMIC STROKE, ACUTE LIMB ISCHEMIA, AND MAJOR AMPUTATION OF VASCULAR ETIOLOGY) IN PATIENTS WITH PAD
11/08/2018
004 9415053*PED 05/13/2025
004 10828310 01/31/2039
U-3207 REDUCTION OF RISK OF CARDIOVASCULAR DEATH, MYOCARDIAL INFARCTION, AND STROKE IN PATIENTS WITH CAD BY ADMINISTERING CLINICALLY PROVEN EFFECTIVE AMOUNTS THAT ARE 2.5 MG RIVAROXABAN TWICE DAILY AND 75-100 MG ASPIRIN DAILY
U-3208 REDUCTION OF RISK OF MYOCARDIAL INFARCTION AND ISCHEMIC STROKE IN PATIENTS WITH PAD BY ADMINISTERING CLINICALLY PROVEN EFFECTIVE AMOUNTS THAT ARE 2.5 MG RIVAROXABAN TWICE DAILY AND 75-100 MG ASPIRIN DAILY
12/09/2020
004 10828310*PED 07/31/2039

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
004
I-824RIVAROXABAN IN COMBINATION WITH ASPIRIN, IS INDICATED TO REDUCE THE RISK OF MAJOR CV EVENTS (CV DEATH, MI, AND STROKE) IN PATIENTS WITH CHRONIC CORONARY ARTERY DISEASE (CAD) OR PERIPHERAL ARTERY DISEASE (PAD)
COMPETITIVE GENERIC THERAPY
10/11/2021
004
I-810PROPHYLAXIS OF VENOUS THROMBOEMBOLISM IN ACUTELY ILL MEDICAL PATIENTS AT RISK FOR THROMBOEMBOLIC COMPLICATIONS NOT AT HIGH RISK OF BLEEDING
COMPETITIVE GENERIC THERAPY
10/11/2022
004
I-810PROPHYLAXIS OF VENOUS THROMBOEMBOLISM IN ACUTELY ILL MEDICAL PATIENTS AT RISK FOR THROMBOEMBOLIC COMPLICATIONS NOT AT HIGH RISK OF BLEEDING
*PED PEDIATRIC EXCLUSIVITY
04/11/2023
004
I-867INDICATED TO REDUCE THE RISK OF MAJOR THROMBOTIC VASCULAR EVENTS (MYOCARDIAL INFARCTION, ISCHEMIC STROKE, ACUTE LIMB ISCHEMIA, AND MAJOR AMPUTATION OF VASCULAR ETIOLOGY) IN PATIENTS WITH PAD, INCLUDING PATIENTS WHO HAVE RECENTLY UNDERGONE A LOWER EXTREMITY REVASCULARIZATION PROCEDURE DUE TO SYMPTOMATIC PAD
COMPETITIVE GENERIC THERAPY
08/23/2024
004
I-867INDICATED TO REDUCE THE RISK OF MAJOR THROMBOTIC VASCULAR EVENTS (MYOCARDIAL INFARCTION, ISCHEMIC STROKE, ACUTE LIMB ISCHEMIA, AND MAJOR AMPUTATION OF VASCULAR ETIOLOGY) IN PATIENTS WITH PAD, INCLUDING PATIENTS WHO HAVE RECENTLY UNDERGONE A LOWER EXTREMITY REVASCULARIZATION PROCEDURE DUE TO SYMPTOMATIC PAD
*PED PEDIATRIC EXCLUSIVITY
02/23/2025

 

 


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