Details for New Drug Application (NDA): 215859
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NDA 215859 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. Four 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. Four suppliers are listed for this compound. Additional details are available on the rivaroxaban profile page.
Summary for 215859
| Tradename: | XARELTO |
| Applicant: | Janssen Pharms |
| Ingredient: | rivaroxaban |
| Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 215859
Generic Entry Date for 215859*:
Constraining patent/regulatory exclusivity:
Dosage:
FOR SUSPENSION;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: 215859
| Mechanism of Action | Factor Xa Inhibitors |
Medical Subject Heading (MeSH) Categories for 215859
Suppliers and Packaging for NDA: 215859
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| XARELTO | rivaroxaban | FOR SUSPENSION;ORAL | 215859 | NDA | Janssen Pharmaceuticals, Inc. | 50458-575 | 50458-575-01 | 1 BOTTLE in 1 CARTON (50458-575-01) / 1 GRANULE, FOR SUSPENSION in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 1MG/ML | ||||
| Approval Date: | Dec 20, 2021 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 20, 2024 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Regulatory Exclusivity Expiration: | Jun 20, 2025 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| Patent: | 7,157,456*PED | Patent Expiration: | Feb 28, 2025 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
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