FDA Orange Book
Is there a generic for Bafiertam?
Bafiertam contains monomethyl. 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 Bafiertam (monomethyl). The Orange Book shows its last listed patent expires February 27, 2035.
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Bafiertam products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, delayed release, oral | 95MG | Marketed (Rx) | None | 0 | None |
NDA 210296, held by BANNER LIFE SCIENCES LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Bafiertam patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11903918 | February 27, 2035 | Method of use | U-1384 | 210296 |
| 10918615 | February 27, 2035 | Drug product | U-1384 | 210296 |
| 10918616 | February 27, 2035 | Method of use | U-1384 | 210296 |
| 11590095 | February 27, 2035 | Method of use | U-1384 | 210296 |
| 9511043 | February 27, 2035 | Method of use | U-1384 | 210296 |
| 9326965 | February 27, 2035 | Method of use | U-1384 | 210296 |
| 9814692 | February 27, 2035 | Method of use | U-1384 | 210296 |
| 9636318 | February 27, 2035 | Method of use | U-1384 | 210296 |
| 9814691 | February 27, 2035 | Method of use | U-1384 | 210296 |
| 10105336 | February 27, 2035 | Drug product | U-1384 | 210296 |
| 9820961 | February 27, 2035 | Drug product | U-1384 | 210296 |
| 10098863 | February 27, 2035 | Drug product | U-1384 | 210296 |
| 9517209 | February 27, 2035 | Drug product | None | 210296 |
| 9566259 | February 27, 2035 | Drug product | None | 210296 |
| 9326947 | February 27, 2035 | Drug product | None | 210296 |
| 10105335 | February 27, 2035 | Drug product | None | 210296 |
| 10105337 | February 27, 2035 | Drug product | None | 210296 |
| 10918617 | February 27, 2035 | Drug product | None | 210296 |
| 9636319 | February 27, 2035 | Drug product | None | 210296 |
| 10945985 | February 27, 2035 | Drug product | None | 210296 |
| 9820960 | February 27, 2035 | Drug product | None | 210296 |
Bafiertam NDC codes
Questions
Is there a generic for Bafiertam?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Bafiertam (monomethyl). The Orange Book shows its last listed patent expires February 27, 2035.
What is the generic name for Bafiertam?
The active ingredient in Bafiertam is monomethyl, per the FDA Orange Book.
When does the Bafiertam patent expire?
The last patent listed for Bafiertam in the Orange Book expires February 27, 2035. 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.