Details for New Drug Application (NDA): 219208
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NDA 219208 describes VANRAFIA, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug. Additional details are available on the VANRAFIA profile page.
The generic ingredient in VANRAFIA is atrasentan hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the atrasentan hydrochloride profile page.
The generic ingredient in VANRAFIA is atrasentan hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the atrasentan hydrochloride profile page.
Summary for 219208
| Tradename: | VANRAFIA |
| Applicant: | Novartis |
| Ingredient: | atrasentan hydrochloride |
| Patents: | 9 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 219208
Generic Entry Date for 219208*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY 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.
Suppliers and Packaging for NDA: 219208
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VANRAFIA | atrasentan hydrochloride | TABLET;ORAL | 219208 | NDA | Novartis Pharmaceuticals Corporation | 0078-1420 | 0078-1420-15 | 30 TABLET, FILM COATED in 1 BOTTLE (0078-1420-15) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 0.75MG BASE | ||||
| Approval Date: | Apr 2, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Apr 2, 2030 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 10,016,393 | Patent Expiration: | Jul 7, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 11,491,137 | Patent Expiration: | Dec 16, 2040 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF PRIMARY IMMUNOGLOBULIN A NEPHROPATHY (IGAN) | ||||||||
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