FDA Orange Book
Is there a generic for Pliaglis?
Pliaglis contains lidocaine and tetracaine. 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 Pliaglis (lidocaine and tetracaine). The Orange Book shows its last listed patent expires January 14, 2031.
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Pliaglis products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | 7%;7% | Marketed (Rx) | None | 0 | None |
NDA 021717, held by CRESCITA THERAPEUTICS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Pliaglis patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12558328 | January 14, 2031 | Method of use | U-4421 | 021717 |
| 10603293 | January 14, 2031 | Drug product | None | 021717 |
| 10751305 | January 14, 2031 | Drug product | None | 021717 |
| 10350180 | January 14, 2031 | Drug product | None | 021717 |
Pliaglis NDC codes
Questions
Is there a generic for Pliaglis?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Pliaglis (lidocaine and tetracaine). The Orange Book shows its last listed patent expires January 14, 2031.
What is the generic name for Pliaglis?
The active ingredient in Pliaglis is lidocaine and tetracaine, per the FDA Orange Book.
When does the Pliaglis patent expire?
The last patent listed for Pliaglis in the Orange Book expires January 14, 2031. 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.