FDA Orange Book
Is there a generic for Tolsura?
Tolsura contains itraconazole. 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 Tolsura (itraconazole). The Orange Book shows its last listed patent expires June 21, 2033.
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Tolsura products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 65MG | Marketed (Rx) | None | 0 | None |
NDA 208901, held by MAYNE PHARMA INTERNATIONAL PTY LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Tolsura patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10463740 | June 21, 2033 | Drug product | U-2453 | 208901 |
| 9713642 | June 21, 2033 | Method of use | U-2453 | 208901 |
| 10806792 | June 21, 2033 | Drug product | None | 208901 |
| 8921374 | June 21, 2033 | Drug product | None | 208901 |
| 9272046 | June 21, 2033 | Drug product | None | 208901 |
Tolsura NDC codes
Questions
Is there a generic for Tolsura?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Tolsura (itraconazole). The Orange Book shows its last listed patent expires June 21, 2033.
What is the generic name for Tolsura?
The active ingredient in Tolsura is itraconazole, per the FDA Orange Book.
When does the Tolsura patent expire?
The last patent listed for Tolsura in the Orange Book expires June 21, 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.