Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 12, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022406

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NDA 022406 describes XARELTO, which is a drug marketed by Janssen Pharms and is included in one NDA. It is available from three suppliers. There are five patents protecting this drug and two Paragraph IV challenges. Additional details are available on the XARELTO profile page.

The generic ingredient in XARELTO is rivaroxaban. There are thirty-five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the rivaroxaban profile page.
Summary for 022406
Tradename:XARELTO
Applicant:Janssen Pharms
Ingredient:rivaroxaban
Patents:5
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 022406
Generic Entry Date for 022406*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 022406
Mechanism of ActionFactor Xa Inhibitors
Medical Subject Heading (MeSH) Categories for 022406
Suppliers and Packaging for NDA: 022406
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
XARELTO rivaroxaban TABLET;ORAL 022406 NDA A-S Medication Solutions 50090-3625 50090-3625-0 90 TABLET, FILM COATED in 1 BOTTLE (50090-3625-0)
XARELTO rivaroxaban TABLET;ORAL 022406 NDA A-S Medication Solutions 50090-4469 50090-4469-0 90 TABLET, FILM COATED in 1 BOTTLE (50090-4469-0)
Paragraph IV (Patent) Challenges for 022406
Tradename Dosage Ingredient NDA Submissiondate
XARELTO TABLET;ORAL rivaroxaban 022406 2018-11-19

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jul 1, 2011TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 27, 2020
Regulatory Exclusivity Use:NEW DOSING REGIMEN OF 10 MG ONCE DAILY FOR THE REDUCTION IN THE RISK OF RECURRENCE OF DEEP VEIN THROMBOSIS (DVT) AND/OR PULMONARY EMBOLISM (PE) IN PATIENTS AT CONTINUED RISK FOR DVT AND/OR PE AFTER COMPLETION OF INITIAL TREATMENT LASTING AT LEAST 6 MONTHS
Patent:  Start TrialPatent Expiration:Aug 28, 2024Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF DEEP VEIN THROMBOSIS (DVT)
Patent:  Start TrialPatent Expiration:Aug 28, 2024Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF PULMONARY EMBOLISM (PE)

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