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 two NDAs. It is available from four suppliers. There are four 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. Eighteen suppliers are listed for this compound. Additional details are available on the rivaroxaban profile page.
The generic ingredient in XARELTO is rivaroxaban. There are thirty-five drug master file entries for this compound. Eighteen 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: | 4 |
Pharmacology for NDA: 022406
| Mechanism of Action | Factor 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 | 50090-3625 | 50090-3625-1 | 12 TABLET, FILM COATED in 1 BOTTLE (50090-3625-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Jul 1, 2011 | TE: | AB | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | Aug 23, 2024 | ||||||||
| Regulatory Exclusivity Use: | INDICATED 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 | ||||||||
| Regulatory Exclusivity Expiration: | Feb 23, 2025 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| Patent: | 7,157,456*PED | Patent Expiration: | Feb 28, 2025 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Expired US Patents for NDA 022406
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Janssen Pharms | XARELTO | rivaroxaban | TABLET;ORAL | 022406-002 | Nov 4, 2011 | 7,585,860 | ⤷ Get Started Free |
| Janssen Pharms | XARELTO | rivaroxaban | TABLET;ORAL | 022406-001 | Jul 1, 2011 | 7,592,339 | ⤷ Get Started Free |
| Janssen Pharms | XARELTO | rivaroxaban | TABLET;ORAL | 022406-004 | Oct 11, 2018 | 7,585,860 | ⤷ Get Started Free |
| Janssen Pharms | XARELTO | rivaroxaban | TABLET;ORAL | 022406-003 | Nov 4, 2011 | 7,592,339 | ⤷ Get Started Free |
| Janssen Pharms | XARELTO | rivaroxaban | TABLET;ORAL | 022406-001 | Jul 1, 2011 | 7,585,860 | ⤷ Get Started Free |
| Janssen Pharms | XARELTO | rivaroxaban | TABLET;ORAL | 022406-002 | Nov 4, 2011 | 7,592,339 | ⤷ Get Started Free |
| Janssen Pharms | XARELTO | rivaroxaban | TABLET;ORAL | 022406-004 | Oct 11, 2018 | 7,592,339 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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