FDA Orange Book
Is there a generic for Veltassa?
Veltassa contains patiromer sorbitex. 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 Veltassa (patiromer sorbitex). The Orange Book shows its last listed patent expires October 8, 2033 and its last listed exclusivity ends October 2, 2026.
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Veltassa products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, oral | EQ 16.8GM BASE/PACKET | Marketed (Rx) | None | 0 | None |
| powder, oral | EQ 1GM BASE/PACKET | Marketed (Rx) | None | 0 | None |
| powder, oral | EQ 25.2GM BASE/PACKET | Discontinued | None | 0 | None |
| powder, oral | EQ 8.4GM BASE/PACKET | Marketed (Rx) | None | 0 | None |
NDA 205739, held by VIFOR PHARMA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Veltassa patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8216560 | March 14, 2027 | Method of use | U-1766 | 205739 |
| 8282913 | May 29, 2027 | Drug product | None | 205739 |
| 8147873 | June 20, 2028 | Drug product | None | 205739 |
| 8337824 | May 29, 2030 | Drug substance | U-1766 | 205739 |
| 9492476 | October 8, 2033 | Method of use | U-1766 | 205739 |
| 9925212 | October 8, 2033 | Method of use | U-1766 | 205739 |
| 11123363 | October 8, 2033 | Method of use | U-1766 | 205739 |
Veltassa exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NS | New strength | October 2, 2026 | 205739 |
| NPP | New patient population | October 2, 2026 | 205739 |
Veltassa NDC codes
Questions
Is there a generic for Veltassa?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Veltassa (patiromer sorbitex). The Orange Book shows its last listed patent expires October 8, 2033 and its last listed exclusivity ends October 2, 2026.
What is the generic name for Veltassa?
The active ingredient in Veltassa is patiromer sorbitex, per the FDA Orange Book.
When does the Veltassa patent expire?
The last patent listed for Veltassa in the Orange Book expires October 8, 2033. 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.