FDA Orange Book
Is there a generic for Nucynta ER?
Nucynta ER contains tapentadol. 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 Nucynta ER (tapentadol). The Orange Book shows its last listed patent expires March 22, 2029.
Run it in Rivvi
Map Nucynta ER and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Nucynta ER products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | EQ 100MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | EQ 150MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | EQ 200MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | EQ 250MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | EQ 50MG BASE | Marketed (Rx) | None | 0 | None |
NDA 200533, held by COLLEGIUM PHARMACEUTICAL INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Nucynta ER patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11344512 | April 21, 2028 | Method of use | U-3391 | 200533 |
| 11344512 | April 21, 2028 | Method of use | U-3392 | 200533 |
| 8536130 | September 22, 2028 | Method of use | U-1276 | 200533 |
| 11344512*PED | October 21, 2028 | Method of use | None | 200533 |
| 8536130*PED | March 22, 2029 | Method of use | None | 200533 |
Nucynta ER NDC codes
Questions
Is there a generic for Nucynta ER?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Nucynta ER (tapentadol). The Orange Book shows its last listed patent expires March 22, 2029.
What is the generic name for Nucynta ER?
The active ingredient in Nucynta ER is tapentadol, per the FDA Orange Book.
When does the Nucynta ER patent expire?
The last patent listed for Nucynta ER in the Orange Book expires March 22, 2029. 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.