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Xarelto is a drug marketed by Janssen Pharms and is included in one NDA. There are five patents protecting this drug and two Paragraph IV challenges.
This drug has one hundred and fifty-six patent family members in forty-seven countries.
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.
Xarelto was eligible for patent challenges on July 1, 2015.
By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 13, 2024. This may change due to patent challenges or generic licensing.
Annual sales in 2018 were $4.6bn, indicating a strong incentive for generic entry.
There have been sixteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
There is one tentative approval for the generic drug (rivaroxaban), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for XARELTO
|Suppliers / Packagers:||3|
|Bulk Api Vendors:||116|
|Formulation / Manufacturing:||see details|
|Drug Prices:||Drug price information for XARELTO|
|Drug Sales Revenues:||Drug sales revenues for XARELTO|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for XARELTO|
|DailyMed Link:||XARELTO at DailyMed|
Generic Entry Opportunity Date for XARELTO
*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.
Recent Clinical Trials for XARELTO
Identify potential brand extensions & 505(b)(2) entrants
|Bill & Melinda Gates Medical Research Institute||Phase 2|
|Radboud University||Phase 4|
|The George Institute||Phase 3|
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||TE||Type||RLD||RS||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|Janssen Pharms||XARELTO||rivaroxaban||TABLET;ORAL||022406-002||Nov 4, 2011||RX||Yes||No||Start Trial||Start Trial||Start Trial|
|Janssen Pharms||XARELTO||rivaroxaban||TABLET;ORAL||022406-002||Nov 4, 2011||RX||Yes||No||Start Trial||Start Trial||Y||Y||Start Trial|
|Janssen Pharms||XARELTO||rivaroxaban||TABLET;ORAL||022406-004||Oct 11, 2018||RX||Yes||No||Start Trial||Start Trial||Y||Start Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>TE||>Type||>RLD||>RS||>Patent No.||>Patent Expiration||>Product||>Substance||>Delist Req.||>Exclusivity Expiration|
|Patent Number||Supplementary Protection Certificate||SPC Country||SPC Expiration||SPC Description|
|1261606||48/2008||Austria||Start Trial||PRODUCT NAME: RIVAROXABAN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/08/472/001 - EU/1/08/472/008 20080930|
|1261606||91497||Luxembourg||Start Trial||91497, EXPIRES: 20230930|
|>Patent Number||>Supplementary Protection Certificate||>SPC Country||>SPC Expiration||>SPC Description|