FDA Orange Book
Is there a generic for Flolipid?
Flolipid contains simvastatin. 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 Flolipid (simvastatin). The Orange Book shows its last listed patent expires February 23, 2030.
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Flolipid products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suspension, oral | 20MG/5ML | Marketed (Rx) | None | 0 | None |
| suspension, oral | 40MG/5ML | Marketed (Rx) | None | 0 | None |
NDA 206679, held by SALERNO PHARMACEUTICALS. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Flolipid patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10300041 | April 26, 2027 | Drug product | None | 206679 |
| 9597289 | February 23, 2030 | Drug product | None | 206679 |
Questions
Is there a generic for Flolipid?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Flolipid (simvastatin). The Orange Book shows its last listed patent expires February 23, 2030.
What is the generic name for Flolipid?
The active ingredient in Flolipid is simvastatin, per the FDA Orange Book.
When does the Flolipid patent expire?
The last patent listed for Flolipid in the Orange Book expires February 23, 2030. 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.