FDA Orange Book
Is there a generic for Nexplanon?
Nexplanon contains etonogestrel. 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 Nexplanon (etonogestrel). The Orange Book shows its last listed patent expires July 28, 2030 and its last listed exclusivity ends January 16, 2029.
Run it in Rivvi
Map Nexplanon 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.
Nexplanon products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| implant, implantation | 68MG/IMPLANT | Marketed (Rx) | None | 0 | None |
NDA 021529, held by ORGANON USA LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Nexplanon patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8888745 | August 28, 2026 | Drug product | None | 021529 |
| 10821277 | May 31, 2027 | Drug product | None | 021529 |
| 8722037 | September 28, 2027 | Drug product | None | 021529 |
| 9757552 | July 28, 2030 | Drug product | U-1 | 021529 |
Nexplanon exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| D-199 | New dosing schedule | January 16, 2029 | 021529 |
Nexplanon NDC codes
Questions
Is there a generic for Nexplanon?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Nexplanon (etonogestrel). The Orange Book shows its last listed patent expires July 28, 2030 and its last listed exclusivity ends January 16, 2029.
What is the generic name for Nexplanon?
The active ingredient in Nexplanon is etonogestrel, per the FDA Orange Book.
When does the Nexplanon patent expire?
The last patent listed for Nexplanon in the Orange Book expires July 28, 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.