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 001
RIVAROXABAN (XARELTO) TABLET 10MG

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 7157456 08/28/2024 DS DP
U-1301 TREATMENT OF DEEP VEIN THROMBOSIS (DVT)
U-1302 TREATMENT OF PULMONARY EMBOLISM (PE)
08/04/2011
001 7157456*PED 02/28/2025
001 9415053 11/13/2024 DP
U-1167 PROPHYLAXIS OF DEEP VEIN THROMBOSIS (DVT)
U-2142 REDUCTION IN THE RISK OF RECURRENCE OF DEEP VEIN THROMBOSIS (DVT) AND/OR PULMONARY EMBOLISM (PE) IN PATIENTS AT CONTINUED RISK FOR RECURRENT DVT AND/OR AFTER COMPLETION OF INITIAL TREATMENT LASTING AT LEAST 6 MONTHS
U-2640 PROPHYLAXIS OF VENOUS THROMBOEMBOLISM IN ACUTELY ILL MEDICAL PATIENTS AT RISK FOR THROMBOEMBOLIC COMPLICATIONS NOT AT HIGH RISK OF BLEEDING
U-3284 PROPHYLAXIS OF THROMBOEMBOLIC DISEASES IN PEDIATRIC PATIENTS AGED 2 YEARS AND OLDER WITH CONGENITAL HEART DISEASE WHO HAVE UNDERGONE THE FONTAN PROCEDURE AND A BODY WEIGHT OF >=50 KG
09/14/2016
001 9415053*PED 05/13/2025
001 9539218 02/17/2034
U-1957 PROPHYLAXIS OF DEEP VEIN THROMBOSIS, WHICH MAY LEAD TO PULMONARY EMBOLISM IN PATIENTS UNDERGOING KNEE OR HIP REPLACEMENT SURGERY, WITH ONCE DAILY, RAPID-RELEASE TABLET ADMINISTERED FOR AT LEAST FIVE CONSECUTIVE DAYS
U-2143 AFTER COMPLETION OF INITIAL TREATMENT LASTING AT LEAST 6 MONTHS, TO REDUCE THE RISK OF RECURRENCE OF DEEP VEIN THROMBOSIS AND/OR PULMONARY EMBOLISM IN CERTAIN PATIENTS WITH ONCE DAILY, RAPID-RELEASE TABLET ADMINISTERED FOR AT LEAST 5 CONSECUTIVE DAYS
U-2641 PROPHYLAXIS OF VENOUS THROMBOEMBOLISM IN ACUTELY ILL MEDICAL PATIENTS AT RISK FOR THROMBOEMBOLIC COMPLICATIONS NOT AT HIGH RISK OF BLEEDING WITH ONCE DAILY, RAPID-RELEASE TABLET ADMINISTERED FOR AT LEAST 5 CONSECUTIVE DAYS
U-3288 PROPHYLAXIS OF PE, DVT AND/OR STROKE IN PEDIATRIC PATIENTS (>=50 KG) AGED 2 YEARS AND OLDER WITH CONGENITAL HEART DISEASE AFTER FONTAN PROCEDURE WITH ONCE DAILY, RAPID-RELEASE TABLET ADMINISTERED FOR AT LEAST 5 CONSECUTIVE DAYS
02/07/2017
001 9539218*PED 08/17/2034

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001
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
001
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
001
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
001
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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