FDA Orange Book
Is there a generic for Miebo?
Miebo contains perfluorohexyloctane. 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 Miebo (perfluorohexyloctane). The Orange Book shows its last listed patent expires June 21, 2037 and its last listed exclusivity ends May 18, 2028.
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Miebo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution/drops, ophthalmic | 1.338GM/ML | Marketed (Rx) | None | 0 | None |
NDA 216675, held by BAUSCH AND LOMB INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Miebo patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10449164 | September 12, 2033 | Method of use | U-1900 | 216675 |
| 10369117 | September 12, 2033 | Method of use | U-1900 | 216675 |
| 10058615 | September 12, 2033 | Method of use | U-1900 | 216675 |
| 12005033 | September 12, 2033 | Method of use | U-4586 | 216675 |
| 10576154 | October 1, 2035 | Method of use | U-1900 | 216675 |
| 10682315 | September 29, 2036 | Method of use | U-4586 | 216675 |
| 11357738 | September 29, 2036 | Drug product | None | 216675 |
| 12128010 | September 29, 2036 | Drug product | None | 216675 |
| RE50060 | June 21, 2037 | Method of use | U-4586 | 216675 |
Miebo exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | May 18, 2028 | 216675 |
Miebo NDC codes
Questions
Is there a generic for Miebo?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Miebo (perfluorohexyloctane). The Orange Book shows its last listed patent expires June 21, 2037 and its last listed exclusivity ends May 18, 2028.
What is the generic name for Miebo?
The active ingredient in Miebo is perfluorohexyloctane, per the FDA Orange Book.
When does the Miebo patent expire?
The last patent listed for Miebo in the Orange Book expires June 21, 2037. 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.