FDA Orange Book
Is there a generic for Neupro?
Neupro contains rotigotine. 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 Neupro (rotigotine). The Orange Book shows its last listed patent expires March 1, 2032.
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Neupro products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| film, extended release, transdermal | 1MG/24HR | Marketed (Rx) | None | 0 | None |
| film, extended release, transdermal | 2MG/24HR | Marketed (Rx) | None | 0 | None |
| film, extended release, transdermal | 3MG/24HR | Marketed (Rx) | None | 0 | None |
| film, extended release, transdermal | 4MG/24HR | Marketed (Rx) | None | 0 | None |
| film, extended release, transdermal | 6MG/24HR | Marketed (Rx) | None | 0 | None |
| film, extended release, transdermal | 8MG/24HR | Marketed (Rx) | None | 0 | None |
NDA 021829, held by UCB INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Neupro patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8246979 | September 1, 2027 | Drug product | U-1272 | 021829 |
| 8246979 | September 1, 2027 | Drug product | U-1273 | 021829 |
| 10130589 | December 22, 2030 | Drug product | None | 021829 |
| 10350174 | December 22, 2030 | Drug product | None | 021829 |
| 9925150 | March 1, 2032 | Drug product | None | 021829 |
Neupro NDC codes
Questions
Is there a generic for Neupro?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Neupro (rotigotine). The Orange Book shows its last listed patent expires March 1, 2032.
What is the generic name for Neupro?
The active ingredient in Neupro is rotigotine, per the FDA Orange Book.
When does the Neupro patent expire?
The last patent listed for Neupro in the Orange Book expires March 1, 2032. 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.