FDA Orange Book
Is there a generic for Vanrafia?
Vanrafia contains atrasentan. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Vanrafia (atrasentan). The Orange Book shows its last listed patent expires March 25, 2043 and its last listed exclusivity ends April 2, 2030.
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Vanrafia products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 0.75MG BASE | Marketed (Rx) | None | 0 | None |
NDA 219208, held by NOVARTIS PHARMACEUTICALS CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Vanrafia patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8623819 | August 22, 2028 | Method of use | U-3980 | 219208 |
| 11874283 | February 18, 2032 | Method of use | U-3980 | 219208 |
| 9364458 | July 7, 2034 | Drug product | U-3980 | 219208 |
| 10016393 | July 7, 2034 | Drug product | None | 219208 |
| 12370174 | December 16, 2040 | Method of use | U-3980 | 219208 |
| 12121509 | December 16, 2040 | Method of use | U-3980 | 219208 |
| 11998526 | December 16, 2040 | Method of use | U-3980 | 219208 |
| 11491137 | December 16, 2040 | Method of use | U-3980 | 219208 |
| 12521369 | March 2, 2041 | Method of use | U-3980 | 219208 |
| 12582631 | March 25, 2043 | Method of use | U-3980 | 219208 |
Vanrafia exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | April 2, 2030 | 219208 |
Vanrafia NDC codes
Questions
Is there a generic for Vanrafia?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Vanrafia (atrasentan). The Orange Book shows its last listed patent expires March 25, 2043 and its last listed exclusivity ends April 2, 2030.
What is the generic name for Vanrafia?
The active ingredient in Vanrafia is atrasentan, per the FDA Orange Book.
When does the Vanrafia patent expire?
The last patent listed for Vanrafia in the Orange Book expires March 25, 2043. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.