FDA Orange Book
Is there a generic for Mitosol?
Mitosol contains mitomycin. 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 Mitosol (mitomycin). The Orange Book shows its last listed patent expires May 21, 2029.
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Mitosol products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| for solution, topical | 0.2MG/VIAL | Marketed (Rx) | None | 0 | None |
NDA 022572, held by GLAUKOS CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Mitosol patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8186511 | July 19, 2026 | Drug product | None | 022572 |
| 9205075 | July 19, 2026 | Drug product | None | 022572 |
| 9539241 | January 2, 2028 | Drug substance, Drug product | U-2095 | 022572 |
| 7806265 | February 1, 2029 | Drug product | None | 022572 |
| 9649428 | May 21, 2029 | Method of use | U-2095 | 022572 |
Questions
Is there a generic for Mitosol?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Mitosol (mitomycin). The Orange Book shows its last listed patent expires May 21, 2029.
What is the generic name for Mitosol?
The active ingredient in Mitosol is mitomycin, per the FDA Orange Book.
When does the Mitosol patent expire?
The last patent listed for Mitosol in the Orange Book expires May 21, 2029. 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.