FDA Orange Book
Is there a generic for Myhibbin?
Myhibbin contains mycophenolate mofetil. 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 Myhibbin (mycophenolate mofetil). The Orange Book shows its last listed patent expires August 16, 2039.
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Myhibbin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suspension, oral | 200MG/ML | Marketed (Rx) | None | 0 | None |
NDA 216482, held by AZURITY PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Myhibbin patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12194143 | August 16, 2039 | Drug product | U-1752 | 216482 |
| 12097285 | August 16, 2039 | Drug product | U-1752 | 216482 |
| 12226526 | August 16, 2039 | Drug product | U-1752 | 216482 |
| 11931455 | August 16, 2039 | Drug product | U-1752 | 216482 |
| 12097284 | August 16, 2039 | Drug product | None | 216482 |
Myhibbin NDC codes
Questions
Is there a generic for Myhibbin?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Myhibbin (mycophenolate mofetil). The Orange Book shows its last listed patent expires August 16, 2039.
What is the generic name for Myhibbin?
The active ingredient in Myhibbin is mycophenolate mofetil, per the FDA Orange Book.
When does the Myhibbin patent expire?
The last patent listed for Myhibbin in the Orange Book expires August 16, 2039. 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.